Meet Us at DIA Europe 2023

Get to know some of the organizations and speakers that will take a part at this yearly landmark in life-science events.

Speakers

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  Virginia Acha, PhD, MSc

  • AVP, Global Regulatory Policy
  • Merck Sharpe & Dohme LLC , United States

  Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

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  Peter Richard Arlett, MD, FFPM, FRCP

  • Head Data Analytics and Methods Task Force
  • European Medicines Agency, Netherlands

  Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

• 

  Sabine Atzor, MPharm, RPh

  • Head of EU Regulatory Policies
  • F. Hoffmann-La Roche Ltd, Switzerland

  Sabine Atzor joined F. Hoffmann-La Roche Ltd in Basel as Head of EU Regulatory Policy in 2010. In this function she has been leading or contributing to numerous discussions within Roche and EFPIA, e.g. EU Clinical Trial Regulation and recently the revision of the EU Pharma Legislation. This included an advisory role to EFPIA as part of a secondment. Prior to joining Roche she worked for about 14 years in the public sector, of which almost 6 years in the Pharmaceuticals Unit of the European Commission, DG ENTR and later at DG SANCO with a focus on the Falsified Medicines Directive. Before that she held different roles in regional health authorities in Germany.

• 

  Alison Bond, PhD

  • Director, Global Regulatory and R&D Policy
  • Amgen, United Kingdom

  Alison is Director of Global Regulatory and R&D Policy at Amgen and is dedicated to shaping the regulatory environment to promote and support innovative, efficient, and effective approaches to developing important new therapies for patients. Alison has been a Regulatory Policy leader for over 10 years, engaging in multi-stakeholder groups and initiatives, such as through EFPIA, IMI/IHI and TransCelerate. She draws upon her extensive R&D experience across the medicine lifecycle, from gaining her PhD to holding senior roles within several CROs and large and small biopharmaceutical companies.

• 

  Thomas Brookland, MSc

  • Regulatory Science and Policy Lead
  • F. Hoffmann-La Roche Ltd, Switzerland

  Thomas (Tom) Brookland has worked in the Pharma industry for the last 15 years, combining interests in regulatory science, health technology and policy research. He joined Hoffmann La Roche in 2008 and in this time has held multiple roles within regulatory product development across molecules and therapeutic areas, in addition to globally and regionally focused policy lead roles in the emerging areas of RWD/RWE, big data, digital health and AI/ML. His current work and passion is focused on strategy and external engagement in the European policy landscape for data, digital and AI, supporting the development of new policy options as the convergence of medical knowledge, technology and data science is revolutionising patient care.

• 

  Ursula Busse, PhD, MBA

  • Head of Regulatory Affairs
  • Tigen Pharma SA, Switzerland

  Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma (Novartis, Boehringer Ingelheim) and small Biotech companies. She is a long time active member of several non-for profit organizations (namely DIA) and speaks four languages fluently. Ursula holds a PhD in cell and molecular biology and an MBA she earned with honors.

• 

  Claudia Cabrera

  • Senior Director Epidemiology & Evidence Excellence, AstraZeneca AB
  • Adj Researcher Karolinska Institute, Dept Epidemiology and Biostatistics, Sweden

  Claudia Cabrera-Moksnes graduated from Tulane University School of Public Health with a master’s degree in Epidemiology. She completed her doctorate degree at Sahlgrenska Academy at Göteborg University, Department of Primary Health Care and she also holds a Licentiate in Medical Science, from 2005. Claudia has worked in Industry for 17 years across all therapy areas and patient safety, of late she has focused on the build of large global studies related to respiratory disease. In her most recent position, she leads studies in Patient Safety, China RWE development as part of the Global Evidence Hub, as well as leading Clinical Trial Diversity research.

• 

  Michelle Crouthamel, PhD

  • Head, Digital Science
  • AbbVie, United States

  Michelle Crouthamel is a recognized industry leader who integrates digital health in pharmaceutical development and collaborates broadly with academics, tech, consortia, and health authorities to create impacts. As the Head of Digital Science at AbbVie, Michelle leads digital strategy and implementation in RCT and RWE. Prior to joining AbbVie, Michelle led many successful R&D programs at Merck and GSK. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health.

• 

  Juan Garcia-Burgos, MD, PhD

  • Head of Public and Stakeholders Engagement Department
  • European Medicines Agency, Netherlands

  Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.

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  Markus Goese

  • Head EU CMC Regulatory Policy
  • F. Hoffmann-La Roche Ltd, Switzerland

  Markus Goese holds a Ph.D. in Biochemistry/ Organic Chemistry from the Technische Universität München (Munich), Germany. He has over 20 years industry experience in various companies (Roche, DSM, Novartis) in Pharmaceuticals and Fine Chemicals Research, Development and Commercialization. For the last 15 years he has been working in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early- and late-stage development, and in 2011 he took on the responsibility as EU Lead CMC Regulatory Policy for Roche Pharma Global Technical Operations. Markus is based in Basel, Switzerland. He is currently Chair of EFPIA's Manufacturing and Quality Expert Group (MQEG), EFPIA topic lead for ICH Q12 and CoLead of EFPIA's PRIME/BT/Covid CMC team

• 

  Fengyun (Vicky) Han

  • Senior Director, Head of Regulatory Policy for Asia Pacific
  • Johnson & Johnson Pte. Ltd., Singapore

  Fengyun (Vicky) Han, the Senior Director, Head of Asia Pacific Regulatory Policy, Global Regulatory Affairs, Johnson & Johnson Vicky has more than 25 years regulatory experience in pharmaceutical industry mainly in GSK ang J&J with various roles in China, Belgium, UK, and Singapore, encompassing a wide range of products, including chemical and biological products, vaccines, biosimilars, and generics. In recent year, she has been involving in many policy areas discussion such as MRCT & ICH E17, RWE, Digital/AL/ML, Cell & Gene Therapy, Orphan Drug, Regulatory Reliance etc.Vicky is the Chair of EFPIA Japan Network, and Vice-Chair of EFPIA China Network.

• 

  Shahid Hanif, PhD, MSc

  • Managing Director
  • GetReal Institute, Netherlands

  Shahid Hanif is the Managing Director of the GetReal Institute, a not-for-profit multi-stakeholder association based in the Netherlands, which aims to facilitate the adoption and implementation of real-world evidence in regulatory, HTA and clinical decision-making in Europe. He leads the GetReal Institute, which follows two Innovative Medicines Initiative (IMI) funded programmes, to establish it as a leading independent and sustainable European forum for stakeholder dialogue, consensus development and co-creation of solutions to advance the use of real-world evidence.

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  Helena Harnik

  • Executive Director
  • The Synergist ASBL, France

  Helena Harnik, MBA, is currently the Program Executive Director at The Synergist, where she oversees the day to day operations and delivery of all the Synergist programmes. Helena has worked with The Synergist since its founding. Helena has previously worked at several companies including Sanofi Pasteur and Gerson Lehrman Group (GLG), successfully showing how to solve societal issues by connecting diverse people together. Helena has an International MBA from EM Lyon in France, and a Bachelor of Arts in English Literature (cum laude) from Williams College in the United States. Based in France, Helena is American – Japanese and has lived in Japan, the UK, USA and France.

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  Inka Heikkinen, MBA, MSc

  • Regulatory Policy Lead
  • Lundbeck, Denmark

  Inka has been involved very closely in HTA Regulation implementation at EFPIA since the very beginning. She leads EFPIA workstream around regulatory-HTA interaction and Joint Scientific Consultation, with extensive work on defining industry positions and thinking around the future processes and system on Marketing Authorisation review process and Joint Clinical Assessment. As her day job, she leads R&D and regulatory policy strategy and operational excellence at Lundbeck, working with senior leaders defining and advocating for policies that optimizes the environment for future health technologies. Inka holds master degrees on health economics and in policy, an Executive MBA degree with specialisation in finance.

• 

  Anne-Sophie Henry-Eude, PharmD

  • Head of Documents Access and Publication Department
  • European Medicines Agency, Netherlands

  Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

• 

  Esteban Herrero-Martinez, PhD

  • Director Regulatory Policy and Intelligence
  • AbbVie, United Kingdom

  Esteban has worked in both academia and industry in a range of roles including academic research, drug discovery, pharmacovigilance and regulatory policy. Before joining AbbVie, Esteban was Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) as well as working in pharmacovigilance for P&G Pharmaceuticals and drug discovery for Novartis. He holds a Biochemistry BSc from Warwick University, PhD in virology from University College London, and has worked as a postdoctoral researcher at Imperial College London

• 

  Milou Hogervorst, PharmD, MSc

  • PhD Candidate
  • Utrecht University, Netherlands

  I studied Pharmacy between 2012-2019 at Utrecht University and added a Master’s in Health Economics Policy and Law from Erasmus University between 2016-2018. Currently I am doing a PhD at the UU within the H2020 HTx project. My interest for research was sparked during an internship on US pharmaceutical pricing policies at the University of California San Francisco where I lived in 2018.

• 

  Tony Humphreys, MPharm

  • Head of the Regulatory Science and Innovation Task Force
  • European Medicines Agency, Netherlands

  Tony is the Head of the Regulatory Science and Innovation Task Force (TRS) responsible for providing leadership in the Task Force and the Agency to enable its continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance. He also provides leadership for supply and availability of medicines under the extended mandate of the Agency.

• 

  Judith Catherine Macdonald

  • Senior Director, Global Policy Development
  • Pfizer, United Kingdom

  Judith is responsible for global regulatory policy development at Pfizer. She has more than 30 years’ experience in regulatory affairs, where she was responsible for registration of small molecule and biological products across the entire development cycle. Judith joined Pfizer in 2007 working in regulatory strategy, public affairs and regulatory policy. In 2016 she moved into a dedicated regulatory policy role heading up the policy team for Pfizer’s essential health products. In January 2019 she became responsible for global policy development on the innovative product portfolio focusing on regulatory science advocacy. Judith serves on IFPMA’s RSC/ICH Management Committee and works with Accumulus on Global regulatory Policy.

• 

  Marina Alexandra Malikova, PhD, MBA, MS, RAC

  • Executive Director, Translational Research, Assistant Professor of Surgery
  • Boston University School of Medicine, United States

  Dr. Malikova has over 15 years of experience in the clinical research field, with 8 years’ experience on executive level. She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

• 

  Michael Meighu, PhD, MS

  • Director AI Lead - Life Sciences
  • CGI, United States

  Dr. Meighu is a specialist in Artificial Intelligence and how it relates to Knowledge Science and Innovation. With 20+ years in the Life Science industry, he has an acute perspective in its data pain points, use cases, and paths for resolutions, in order to create more robust innovation ecosystems. His AI and related experiences includes building complex Ontology systems to make data inter-operable and improve search, Natural Language Processing, and Classification.

• 

  Anne Moen, PhD, MSc, RN

  • Professor, Faculty of Medicine, Coordinator, Gravitate-Health
  • University of Oslo, Norway

  Prof. Anne Moen, is at the Faculty of Medicine at the University of Oslo, Oslo, Norway, and Norwegian Center for eHealth Research, Tromsø, Norway. In her 25 years of research she combines health, nursing and informatics for design and deployment of citizen centered digital tools and services, emphasizing empowerment, digital health literacy and engagement for health and wellness. She is Coordinator of “Gravitate – Health”, IMI project with 39 partners in 15 countries, 2020-2025. She is a Registered Nurse, holds a PhD in Social Sciences with specialization in health informatics, elected Fellow of the American college of Medical Informatics and honorary fellow of EFMI (European Federation for Medical Informatics).

• 

  Mireille Muller, DrSc, PhD, MSc

  • Regulatory Policy & Intelligence Director
  • Novartis Pharma AG, Switzerland

  Mireille Muller Ph.D. has over 25 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, expedited regulatory pathways, and innovative clinical trials such as innovative clinical trial designs, decentralised trials and digital health systems. Involved in several public private partnerships IHI/IMI programs and pre-competitive collaboration.

• 

  Koen Nauwelaerts, PharmD, PhD, MBA

  • Regulatory Policy and Innovation Lead
  • Bayer AG, Belgium

  Koen Nauwelaerts holds a Master’s degree in Pharmacy from Leuven University, Belgium and a PhD in Drug Development from the same university. Further he obtained an MBA degree from Vlerick Business School and completed the technology immersion program at MIT. Koen is currently working at Bayer as RA Policy and Innovation Lead. He joined Bayer as head of regulatory affairs and quality for the Belgium/Luxemburg region and previously has been active within MSD and Medicines for Europe in different roles in Regulatory Affairs and Quality. Within his current role as RA Policy and Innovation Lead, Koen leads the internal global e-labeling initiatives at Bayer and is vice-chair of the Inter Association TaskForce (IATF) for ePI.

• 

  Francesco Pignatti, MD

  • Scientific Adviser for Oncology
  • European Medicines Agency, Netherlands

  Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In 1999 he joined the European Medicines Agency (EMA) in London, UK. Since 2009, he has held the position of Head of Oncology, Haematology and Diagnostics in the Human Medicines Evaluation Division. In 2023 he was appointed as Scientific adviser for oncology. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

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  Matt Popkin, PhD

  • Senior Director, CMC Excellence, Global Regulatory Affairs
  • GSK, United Kingdom

  Matt Popkin has a degree in Chemistry from the University of Bristol and a PhD from University College London. Following postdoctoral research, he joined GSK to work as synthetic chemist in 2000. Since then, he has worked in a number of roles in the CMC development and registration of novel medicines. In his current role he is responsible for CMC Policy, Devices and vaccines facilities. Matt is vice-chair of Manufacturing and Quality Expert Group of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Amongst his roles for EFPIA, he leads the CMC PRIME/COVID task force, has been a member of the ICH Q11 Implementation Working Group, and currently represents EFPIA on the ICH Quality Discussion Group.

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  Claudia Popp

  • Head EU Regulatory Science and EMA Liaison
  • F. Hoffmann-La Roche Ltd, Switzerland

  Claudia Popp is the Head EU Regulatory Science & EMA Liaison at Roche. As a senior leader, Claudia has worked for the pharmaceutical industry for more than 20 years and joined Hoffmann La Roche in 2008. She has substantial experience in global regulatory affairs and has held multiple roles within regulatory product development across molecules and therapeutic areas. She combines substantial experience of EMA and FDA processes with a deep knowledge of Health Authority interactions at national level, having held the role of Head Drug Regulatory Affairs at the Roche German Affiliate. The scope of her work includes complex drug/device interfaces.

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  Valerie Powell, MS

  • Chief Patient Officer, CorEvitas and EVP, Patient Experience
  • CorEvitas, LLC, United States

  Valerie Powell has over 35 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She is the Chief Patient Officer of CorEvitas, ensuring the organization's services center on and address the needs of patients worldwide. As EVP, Valerie also oversees business growth and delivery for Patient Experience Team of CorEvitas, where research teams use a range of methodologies to uncover insights into the patient lived experience. Ms. Powell is passionate about learning what matters most to patients and finding the most effective ways to motivate and engage them across the product lifecycle.

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  Lars Rugholm, MSc

  • Senior Adviser
  • Danish Medicines Agency (DKMA), Denmark

  Senior Adviser and Innovation Coordinator in the office of International Relations at the Danish Medicines Agency (DKMA). Have previously worked at the DKMA Data Analytics Centre and took part in drafting the DKMA Data Ethics Charter that was published in July 2022.

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  Tina Wang, MSc

  • Senior Manager, HTA programme and strategic partnership
  • CIRS- Centre For Innovation In Regulatory Science, United Kingdom

  Tina leads CIRS’ work on HTA strategy and research as part of the CIRS mission to advance regulatory and HTA policies and processes. Tina's responsibilities cover all aspects of HTA activities (project managing the CIRS HTA Programme, coordinating a HTA steering committee, executing and implementation of metrics studies evaluating the HTA processes within companies and agencies,independent literature research, designing specialised surveys,construction and maintenance of the Regulatory and Reimbursement Atlas Platform). Tina is responsible for developing the CIRS HTA Programme research strategy,ensuring alignment between the overarching CIRS regulatory and HTA vision, and leading the strategic partnership with multi-stakeholders globally.

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  Amira Younes

  • Director, Global Regulatory Policy EEMEA
  • MSD, United Arab Emirates

  Amira is the Global Regulatory Policy Director for Eastern Europe, Middle East, and Africa at MSD. With over 15 years in Regulatory Science and Policy, she’s a thought leader in reliance, work sharing, and regional harmonization. She’s built a network to advance regulatory science in the region. She chairs the EFPIA Middle East Regulatory Network (MERN) and is an active member of several trade associations including IFPMA ,PhRMA, and an industry network for Southeast Europe. She regularly presents at DIA conferences and has contributed to publications on regulatory topics. She holds a bachelor’s degree in Pharmacy and Biotechnology from the German University in Cairo.

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  Blythe Adamson, PhD, MPH

  • Principal Scientist
  • Flatiron Health, United States

  Blythe Adamson is an epidemiologist and economist accelerating the development of valuable medicines and health policy. She serves as Principal Scientist at Flatiron Health in NY, advancing the use of machine learning in the curation of electronic health records for real world evidence. She designs treatment comparative-effectiveness studies, codes mathematical models of disease, and delivers research for global health technology assessment. Dr. Adamson served as the lead data scientist in The White House. She is an Affiliate Professor in the Comparative Health Outcomes, Policy, and Economics Institute at the University of Washington and has held roles at the Bill and Melinda Gates Foundation. She continues to be a leader in the ISPOR.

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  Susana Almeida, PhD

  • Clinical Development and Safety Director
  • Medicines for Europe, Belgium

  Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe. Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. She has worked in clinical development in Europe and in North America, and her experience includes the pharmaceutical industry and clinical research organizations. At Medicines for Europe, Susana is responsible for the coordination of multiple working groups involving policy and regulatory science and is currently engaged in the ICH M13 EWG (and previously in M9 and the Generic Discussion Group). She holds a PhD from the Faculty of Medicine, Universidad Autònoma de Barcelona and has authored numerous publications.

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  Billy Amzal, PhD, MPA, MSc

  • CEO
  • Quinten Health, France

  Billy Amzal is a mathematical engineer from Ecole Polytechnique and holds an award-winning PhD in Bayesian Optimal Design. Over the past 20 years, Billy has developed quantitative methodologies to inform strategic decision making in healthcare. Prior to joining Quinten Health as CEO, Billy led the model-based drug development at Novartis. He then headed analytical/data science groups with various public health agencies. Billy acts as data science, Bayesian statistician and predictive modelling expert for public Health Authorities (EFSA, ANSES, WHO, Gates Foundation). He has led hundreds of RWD projects, authored 100+ publications, defended/submitted 100+ regulatory and reimbursements dossiers, and led 100+ data modelling or ML projects.

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  Susanne Ausborn, PhD

  • Global Head International Regulatory Policy
  • Roche, Switzerland

  Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global convergence of regulatory requirements and has been engaged in many international conferences, workshops and meetings with regulators from various emerging markets around the world over the last decade. Currently, she is the Vice Chair of the EFPIA IREG, member of EFPIA Middle East network and several IFPMA expert groups.

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  Samvel Azatyan, MD, PhD

  • Team Lead, Regulatory Convergence and Networks (RCN/REG)
  • World Health Organization (WHO), Switzerland

  Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

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  Gesine Bejeuhr, PharmD

  • Pediatric Regulatory Leader
  • Bayer AG, Germany

  Gesine Bejeuhr, PharmD, PhD, is responsible for generating and implementing global pediatric regulatory strategies and for pediatric regulatory science innovation within Bayer AG. She also provides advice to pediatric development teams. Gesine represents Bayer in the Pediatric WGs of EFPIA, PhRMA, and BIO. She is Vice-Chair of EFPIA's Pediatric Expert Group and member of EFGCP's Children's Medicines Working Party. In her previous role at the German trade association vfa she was responsible for Regulatory Affairs, Production, Quality and Environment and in addition coordinated and co-chaired the Inter-Association-Task Force of EFPIA, Medicines for Europe and AESGP on eProductInformation (ePI) and a German pilot project on ePI.

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  Susan Bhatti, PhD

  • Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs
  • Merck BV, Netherlands

  Susan Bhatti has been working in Regulatory Affairs in the pharmaceutical and clinical research industry for more than 25 years. At Merck BV she is Director EU Global Regulatory and Scientific Policy and is responsible for supporting the development of regulatory and scientific policies as well as responding to regulatory & legislative issues that impact product development. She is co-chair of the Clinical Research Expert Group at EFPIA as well as a co-chairing subgroup focussed on patient engagement. She is currently co-leading a multi-stakeholder initiative on cross-border access to clinical trials in Europe (EU-X-CT), which is a joint undertaking by the European Forum for Good Clinical Practice and EFPIA.

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  Agnete Louise Bjerregaard Nielsen

  • Principal Advisory Consultant
  • NNIT, Denmark

  Agnete has extensive experience from biomedical research and drug development including master data management, process optimization and system implementation. Hence, she has an excellent understanding of the R&D value chain and data flow. As an advisory consultant, Agnete bridges the Line of Business and IT and she puts great value in delivering the right, data-driven solutions by thinking data before technology and linking business goals to technical capabilities. Agnete specializes in data enablement by making the right data available to the right people at the right time.

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  Karl Broich, DrMed

  • President
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany

  Prof. Broich is a physician and has been President of the Federal Institute for Drugs and Medical Devices in Bonn since 2014. His current activities in the European network of regulatory authorities are Member of the Management Board of the European Medicines Agency, Chair of the Network Portfolio Advisory Group. He is a member of the HMA Management Group and is currently its Chair. He is also co-chair of the EMA's Darwin EU Advisory Board. His scientific focus is on clinical psychopharmacology, imaging of neurodegenerative diseases and other potential biomarkers and dementia, and clinical trial methodology, among others. Prof. Broich is author and co-author of more than 220 papers (original scientific papers, reviews, book contributions).

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  Sérgio Cavalheiro Filho, MPharm

  • Manager, Regulatory Affairs
  • IFPMA, Switzerland

  Sérgio works with different IFPMA regulatory workstreams in the development of technical policy documents and implementation of related advocacy activities for regulatory system strengthening, manufacturing quality, and regulatory reliance. He also spearheaded IFPMA’s contribution toward the establishment of the Fight the Fakes Alliance. Before joining IFPMA, Sérgio worked on late-stage drug formulation and development, and as a community pharmacist in Portugal. Sérgio holds a Diploma in Advanced Studies in Management of Clinical Trials from the University of Geneva and a Master in Pharmaceutical Sciences from the University of Coimbra, Portugal.

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  Alison Cave, PhD

  • Chief Safety Officer
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

  Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

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  Christophe Clement

  • Director Business Development
  • ICTA PM, France

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  Evjatar Cohen

  • Global Head of Life Sciences Industry Solutions
  • ServiceNow , Switzerland

  Evi is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. He is a skilled innovation and process management professional. As Global Head of Life Sciences at ServiceNow Evi leads the Life Sciences strategy and solutions approach, creating value for patients. Prior to ServiceNow Evi was VP Global Life Science & Healthcare at Appian, VP Global Innovation at Catalent and held roles in Legal Affairs, R&D, Clinical Operations, Quality, CSV, Regulatory and Program Management. He holds an M.B.A. in Pharmaceutical Management, M.S. in Biotechnology, and a B.S. in Chemistry.

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  Solange Corriol-Rohou, DrMed, MD, PhD

  • Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
  • AstraZeneca , France

  Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI/IHI, and passionate about paediatric drug development, rare/ultra-rare diseases and drug development optimisation.

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  Helena Corte-Real Correia, PhD

  • Regulatory Portfolio Data and Content Lead
  • F. Hoffmann-La Roche Ltd, Switzerland

  Helena Corte-Real Correia is the VP, Regulatory Portfolio Data and Content Lead within Product Development at Roche. With a PhD in Marine Genetics from the University of Liverpool and over 10 years of research in molecular genetics at Oxford University, the Portuguese National Institute of Health, and Basel University, she transitioned to the pharmaceutical industry to apply her scientific knowledge and skills to advance healthcare. She joined the Regulatory Affairs group at Roche in 2003 and has had various roles of increasing responsibility as Late Stage Head for Regulatory Documentation, Global Head of Regulatory Operations and Regulatory Portfolio Data and Content Leader.

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  Annick De Bruin, MBA

  • Chief Research and Insights Officer, Research Services
  • CISCRP, United States

  Annick de Bruin is the Senior Director of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards. She has more than 25 years of experience conducting primary and secondary research studies in the healthcare, life sciences and consumer goods industries. She holds an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University.

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  Jean-Christophe Delumeau, MD, PhD

  • Senior Expert
  • Institute of Pharmacovigilance, Czech Republic

  Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan. In 2002 he was appointed by Bayer to lead pharmacovigilance organisations in Japan (until 2009) then in Asia-Pacific. He is a founding member and coordinator of ISoP’s Special Interest Group on Risk Minimisation Methods for Asian Countries. His focus is to create and facilitate the deployment of novel risk minimization methods applicable to a wide array of countries and health care systems, especially in developing countries.

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  Laurent Desqueper

  • IDMP Business Data Lead
  • -, Belgium

  Laurent has over 20 years experience in Pharmaceutical Regulatory Affairs, including 10 years at MSD Europe and 10 years of consultancy for the European Medicines Agency. At MSD, Laurent has been focused on the business IDMP implementation. Laurent has also been externally focused, as IDMP/SPOR Task Force Industry Co-Chair until Jan-2023, one of the 4 PMS SMEs and EFPIA’s European Regulatory Affairs & Operations (ERAO) IDMP Subgroup co-chair since January 2022.

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  Douglas Drake, MBA

  • Digital Health Strategy
  • NMS HEALTH, Switzerland

  Douglas Drake, MS, MBA, is originally a life science researcher with a passion for digital enablement of better patient care. With over 30 years of experience working in various aspects of diagnostics, therapeutic research and drug discovery, Douglas has broad experience in transformative technologies, data sciences, global business development and applying these to improving patient engagement and the patient journey.

• 

  Maria Dutarte, MA

  • Executive Director
  • European Patients Academy (EUPATI), Netherlands

• 

  Jelena Duza

  • Junior Public Affairs Manager
  • Novartis, Switzerland

• 

  Theo Favard

  • Vice President of External Relations
  • European Pharmaceutical Students' Association (EPSA), Belgium

  Theo is a 5th year pharmaceutical student from Montpellier, in the south of France. He is currently an intern at EFPIA in the Science Policy and Regulatory Affairs team and Vice President of External Relations in EPSA. He is responsible for sponsorships and partnerships of EPSA, in charge of taking care of the EPSA interests in European organisations based in Brussels and also to carry out tasks as EPSA Permanent Officer. Theo is also responsible for the following Coordinators: Mobility and Professional Affairs and in charge of ensuring that they are well performing and fulfilling their tasks and in the absence of any of them take over their responsibilities.

• 

  Jan Geissler, MBA

  • Managing Director
  • Patvocates, Germany

  Jan Geissler is the founder and CEO of Patvocates. He also was the Director of EUPATI. As a patient advocate, he co-founded the patient organisations LeukaNET, WECAN, CML Advocates Network, Acute Leukemia Advocates Network and ECPC. Jan represents patients in committees of EU projects and medical societies and is a member of an ethics committee.

• 

  Andrew Gray, PhD

  • Director, QA Clinical Therapeutic Area Head
  • Johnson & Johnson, United Kingdom

  Andrew is a member of Johnson and Johnson's R&D Quality organisation where he has responsibility for risk-based audit strategies across the company’s clinical therapeutic areas. With an active interest in the use of RWE for regulatory decision making, Andrew was responsible for establishing the EUCOPE RWE Focus Group while working in Amgen’s Global R&D Policy group. Prior to his return to the pharmaceutical industry, Andrew was a Deputy Director and Head of the Medicines Inspectorate at MHRA. Andrew has led international regulatory groups for the OECD, EMA and the EC. Andrew’s experience includes 15 years in academic research and pharmaceutical drug development, with a scientific background in cardiovascular disease & tissue repair.

• 

  Paolo Guerra

  • Medtech Director and Principle Consultant
  • ProductLife Group, France

  Paolo Guerra has Paolo has over 20 years of experience in Life Science industry, and is MedTech Director and Principle Consultant to ProductLife Group. His main profile includes QA manager, Risk Manager, V&V Specialist and RA correspondent. As medical devices platform lead, he ensures all customer-related projects are properly supported and meet the guidelines set by the client. He is responsible for all projects in device vigilance, CE marking, and quality assurance, building on PLG’s existing portfolio and areas of expertise.

• 

  Sabine Haubenreisser, PhD, MSc

  • Principal Scientific Administrator, Stakeholders and Communication Division
  • European Medicines Agency, Netherlands

  Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.

• 

  Claudia Hey, DrSc, PharmD

  • Senior Director, Head Europe Global Regulatory & Scientific Policy
  • Merck Healthcare KGaA, Germany

  Claudia has extensive regulatory affairs expertise (> 20 years) including clinical and pediatric development, registration, and life-cycle management of medicinal products in oncology, immunology and general medicines. At EFPIA Claudia is chairing the Scientific Dialogue WG which compiled the EFPIA Reflection paper on integrated R&D product support along the product lifecycle. The group currently works on Qualifications providing recommendations for improving this important development tool. She is also a member in the EFPIA Expedited Pathways WG and the Pediatrics WG. Claudia holds a Doctorate in Pharmacy from the University of Frankfurt.

• 

  Kenneth Hu, PharmD, MBA

  • Senior Manager (US Reg Lead), Global Regulatory Strategy & Policy, Oncology
  • Bristol Myers Squibb, United States

  Kenneth is a US Regulatory Lead and former Fellow with the Rutgers Pharmaceutical Industry Fellowship Program. As a Fellow he supported Regulatory Science and Policy, Strategy, and Advertising and Promotion across I&I, oncology, and primary care while also gaining insight into digital therapeutics, Value & Access, and field positions. As an adjunct faculty at Rutgers University, Kenneth presented at conferences around the globe on topics including RWE, AI, and policy. Kenneth received his Doctor of Pharmacy degree and MBA degree from Rutgers. Kenneth looks forward to engaging with attendees and speakers at DIA.

• 

  Angelika Joos, MPharm

  • Executive Director, Global Regulatory Policy
  • MSD, Belgium

  Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.

• 

  Katrin Manlik

  • Senior Lead Data Scientist
  • Bayer AG, Pharmaceuticals, Germany

  Katrin Manlik is a Senior Lead Data Scientist in Medical Affairs & Pharmacovigilance at Bayer Pharmaceuticals. She brings 18 years of experience in pharmacovigilance in various roles of increasing responsibility as Safety Data Analyst, Signal Detection Lead and PV Data Scientist. In her current role, she is driving digital innovation projects in PV to utilize novel technologies, advanced analytical tools and data sources. Katrin has been engaged in several workstreams of multi-stakeholder initiatives, such as IMI and TransCelerate around safety signal detection and signal assessment. She holds a master's degree in Computer Science from TU Dresden, Germany.

• 

  Mary Lynn Mercado, PhD

  • Senior Group Head Regulatory Writing
  • Novartis Pharmaceuticals Corporation, United States

  Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas. On the Clinical electronic Structured Harmonised Protocol (CeSHarP) M11 EWG, Mary Lynn is the Deputy Topic Lead for PhRMA. She participates in the TransCelerate Clinical Content & Reuse (CC&R) workstream, where she is the lead for Strategic Engagement. Additionally, Mary Lynn has a PhD in Pharmacology and over 10 years of experience in Neuroscience research and drug discovery.

• 

  Alexandra Moens

  • Director of Product Marketing
  • H1, United States

  Alexandra Moens is a PharmD who has been part of the clinical industry for over 6 years. Her aim is to make a positive impact on patient lives by working with innovative solutions, implementing enhanced clinical strategies and increasing diversity and equity in the drug development lifecycle. Her scientific background and experience working with pharmaceutical partners hand-in-hand have positively impacted clinical teams to get new insights to successfully manage their portfolio strategy in the fast evolving clinical industry.

• 

  Rodrigo Palacios, MBA

  • Executive Director, Technical Regulatory Policy
  • F. Hoffmann-La Roche, Switzerland

  Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's deputy topic lead in the ICH M4Q R2 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

• 

  Nikos Paragios

  • President & Chief Executive Officer
  • TheraPanacea, France

  Nikos Paragios (50) is distinguished professor of Mathematics (on partial leave) at Ecole CentraleSupelec, the school of engineering of the University of Paris-Saclay and Chief Executive Officer of TheraPanacea.Pr. Paragios received an IBM faculty award in 2014, a European Research Council excellence award in 2011 while in 2008 was the laureate of the Greece's (nationality or descent) highest honor (world-wide) for young academics and scientists, the Bodossaki Prize. In 2006, he was named one of the top 35 innovators world-wide innovators under the age of 35 from the MIT's Technology Review. Professor Paragios is member of the scientific council of Safran conglomerate.

• 

  Marjon Pasmooij, PhD

  • Head Science Department / Associate Professor of Drug Regulatory Science
  • Dutch Medicines Evaluation Board / Utrecht University, Netherlands

• 

  Mark Perrott, PhD

  • Managing Partner
  • Axian Consulting Ltd., United Kingdom

  Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit-risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.

• 

  Marc Philipp

  • Partner & Managing Director
  • Kearney, Germany

  As a Partner & Managing Director at KEARNEY, Marc acts as a senior advisor to executive leaders in Biotech and Pharmaceuticals on shaping and executing strategies to achieve competitive advantage through superior performance/ productivity improvement and top-line growth. He also leads a premier team of strategy consultants in Germany, Switzerland and Austria, seamlessly embedded in KEARNEY’s global Healthcare & Life Sciences practice. With almost 20 years of experience across the healthcare and biomedical ecosystem, he brings strong first-hand experience in discovery, development, commercial launch and lifecycle management of drugs, devices, diagnostics and services across a number of specialty medicine therapeutic areas.

• 

  Elena Popa, MPharm

  • Regulatory Policy and Innovation Lead
  • Bayer, Switzerland

  Elena is a pharmacist by training with a master in drug safety and pharmacovigilance. She joined Bayer as a Regulatory Policy & Intelligence Lead and provides direction and development of Regulatory Policy & Intelligence activities supporting Bayer’s pipeline and strategies, with a particular emphasis on the regulatory use and acceptance of RWD/RWE in drug development. Before joining Bayer, Elena was a Senior Manager, Scientific Programmes at Drug Information Association and engaged annually with over 500 stakeholders and volunteers from the entire healthcare ecosystem. In her free time, Elena is passionate about traveling, visiting art museums, painting and watching Formula 1 (#essereFerrari).

• 

  Smita Robinson

  • Director - Regulatory Labelling
  • Pfizer, United Kingdom

  Smita has over 20 years of experience in the pharma Industry at Pfizer. Her career started within pharmaceutical sciences where she had the role of clinical supplies manager. Here she worked on the delivery of clinical supplies demand, manufacturing, packaging and distribution for Human Health and Veterinary medicinal products. She then moved to Regulatory Operations. She was a labelling manager developing core labelling, USPI and EU CP labelling. From here she took on the role of leading and developing the translations model and organisation for regulatory operations. This then led to heading up the Investigator Brochure team. Today Smita works with the international labelling organisation leading the Digital Labelling Centre.

• 

  Stephan Roenninger, DrSc

  • Director, Quality External Affairs
  • Amgen (Europe) GmbH, Switzerland

  Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

• 

  Sharmila Sabaratnam

  • Senior Director, Vault Safety Strategy, EU
  • Veeva Systems, United Kingdom

  Sharmila Sabaratnam is a Senior Director at Veeva Systems responsible for EU SMB Vault Safety Strategy helping customers to transform their business through a unified safety platform. A physiologist by training with research experience within oncology and arthritis. She has 10+ years’ experience within safety, previously leading safety and regulatory advisory services for Top-25 and Top-100 companies within Ernst & Young and Navitas. Her experience includes operating model design and safety strategy, PV automation, benefit-risk management, and performance benchmarking. As a senior leader within the NHS,she led R&D clinical operations with a large oncology clinical trials portfolio, including the Biomedical Centre for Translational Research.

• 

  Junko Sato, PhD

  • Associate Executive Director
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as a guest reviewer from 2002-2003, and in EMA as the Japan Liaison Officer from 2012-2014. She is actively involved in many academic societies, and contribute them as counselor, committee member, and a board member.

• 

  Phil Tregunno

  • Deputy Director - Patient Safety Monitoring
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

  Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

• 

  Katherine Tyner, PhD

  • FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
  • FDA, United States

  Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical Quality (OPQ), Dr. Tyner led the OPQ Science Staff in coordinating the intersection between science, review, and policy as well as facilitating interactions among FDA Centers and Offices. Prior to her appointment as liaison, Dr. Tyner was in the Office of Science and Technology Policy within the Executive Office of the President working on efforts to increase technology transfer across the research, development, and deployment continuum.

• 

  Adrian van den Hoven

  • Director General
  • Medicines for Europe, Belgium

  Adrian van den Hoven joined Medicines for Europe as a Director General in September 2013. His priorities at Medicines for Europe are to stimulate competition in off-patent medicine markets, to foster market access for generic, biosimilar and value added medicines, to support policy measures for sustainable pricing, to promote high regulatory standards while ensuring that the associated costs can be integrated into market dynamics and to develop a coherent EU industrial strategy to support the long-term viability of the generic, biosimilar and value added medicines industries.

• 

  Sarah Vaughan

  • Head of Vigilance Operations
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

  Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation of the Agency's vigilance systems for all medicinal product types.

• 

  Emmanuel Walckenaer, MS

  • CEO
  • Yseop, France

  Emmanuel joined Yseop as CEO in 2017, leading the company’s growth and vision to bring the benefits of automation and NLG to enterprise companies globally. He brings over 25 years of international experience in high-tech service and business development. He joined from Sierra Wireless, where he was General Manager and Senior Vice President of the Cloud & Connectivity Services business unit. He led the growth of this unit across Europe and North America through strategic acquisitions and the development of a bespoke cloud and connectivity offering for the expanding Internet of Things (IOT) market.

• 

  Kathy Wang, MSc, RAC

  • CMC Regulatory Affairs Director
  • AstraZeneca, Sweden

  Kathy Wang is a regulatory affairs professional with strong record in the medical device and drug-device combination product field. In her current position as a Regulatory Affairs Director, Devices and Digital Therapeutics at Astrazeneca, she supports the company in developing and marketing drug and device combined products. She provides regulatory strategy support to projects from pre-clinical phase to marketing. Before joining Astrazeneca, she was responsible for the development and implementation of global regulatory strategies of implantable medical devices at Cochlear Ltd. Having lived and worked in China, Australia and Sweden, Kathy has extensive experience and strong interest in international regulatory affairs.

• 

  Anne Willemsen, MSc

  • Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals
  • ZIN - National Health Care Institute, Netherlands

  Anne holds double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment and Health Policy. This led her through research and project management roles within the Dutch National Healthcare Institute (Zorginstituut Nederland) since 2016 and she lead the EUnetHTA 21 Joint Clinical Assessment (JCA) Secretariat. Since April 2023, she is the co-chair of the HTA Coordination Group Subgroup on JCA under the HTA Regulation.

• 

  Youness Ameur

  • Regulatory Associate Program Director
  • Roche, Switzerland

  Youness holds a Pharm.D and a Master’s in European and International Regulatory Affairs. He joined Roche in 2019 as a trainee in the EU Policy and Regulatory Intelligence group and experienced a Regulatory Program Manager role. He is now working as Regulatory Associate Program Director at F. Hoffmann-La Roche in the Rare disease Franchise. He is in charge with the cross functional team for defining and executing the regulatory strategy for the development and registration of innovative products. Prior to joining Roche, he worked in the public sector for the French national competent authority (ANSM) and the European Medicines Agency where he acquired a thorough knowledge on how the EU network and regulatory system operate.

• 

  Priya Bahri, PhD, RPh

  • Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
  • European Medicines Agency, Netherlands

  Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

• 

  Anne Bourrelly, MBA, MSc

  • Regulatory Innovation & Sustainment Leader
  • F Hoffmann-La Roche Ltd , Switzerland

  Anne has over 30 years experience in drug development, the past 18 years with F. Hoffmann-La Roche PD Regulatory, covering Labeling, Program Management and Regulatory Operations. She joined Roche´s IDMP/SPOR program in 2018 as master data process alignment lead and in 2023 became SPOR lead. Anne is also externally focussed, serving as EFPIA’s European Regulatory Affairs & Operations (ERAO) IDMP Subgroup co-chair in 2022 and as their chair since 2023. She has been PMS Focus Group Data Industry lead and is member of the PMS Industry Support Team since 2023.

• 

  Patrick Brady, PharmD

  • Global Head, Therapeutic Innovation & Regulatory Science
  • IQVIA, United States

  With more than two decades of experience in Regulatory Affairs in the biopharmaceutical industry, Patrick Brady, PharmD, Global Head, Therapeutic Innovation & Regulatory Science, IQVIA, regularly advises R&D leadership and project teams on global drug development strategies, emerging technologies and the changing regulatory landscape and policies to help inform strategies and decision-making.

• 

  Magda Chlebus, MA

  • Executive Director, Science Policy & Regulatory Affairs
  • EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

  Magda Chlebus is Executive Director Scientific & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D-based pharmaceutical industry in Europe. Magda and her team are in charge of following policy and legislative developments that influence the research and regulatory environments for the healthcare industry in Europe. She joined EFPIA in 1995. Her experience covers public and government affairs mainly at EU level, on a range of legislative and non-legislative files in the area of research, development and access to medicines and enabling technologies. Magda, a Polish national, holds a Master Degree in Applied Linguistics from the University of Warsaw.

• 

  Vicki Edwards, RPh

  • Vice President, Pharmacovigilance Excellence and International QPPV
  • Abbvie, United Kingdom

  Vicki, a qualified pharmacist, began her career in hospital pharmacy and later specialized in Drug Information Services, setting up Kuwait's first National Drug Information Centre. After returning to the UK and spending four years in community pharmacy, she transitioned to pharmacovigilance, joining Abbott as EU QPPV in 2005. She stepped down as AbbVie EU QPPV in 2018 due to Brexit. Now, as Head of PV Excellence and International QPPV, Vicki oversees the QPPV Office, Global Safety Compliance, and Risk Management. She is passionate about pharmacovigilance and developing teams.

• 

  Claudia Ferreira

  • Scientific Programs Manager
  • DIA, Switzerland

• 

  Zaide Frias, PharmD

  • Head of Digital Business Transformation Task Force
  • European Medicines Agency, Netherlands

  Zaïde Frias has degrees in Pharmacy and Business Administration. Prior to joining the European Medicines Agency she worked in Pharmaceutical Industry. She joined the EMA in 1999; she was appointed Head of Human Medicines Research & Development Support Division in 2013 and Head of Head of Human Medicines Evaluation Division in 2016. In 2020, she took the position of Head of Digital Business Transformation Task Force. The Digital Business Transformation Task Force was created to drive complex, disruptive change initiatives that have a profound impact on the strategy of EMA, its operational structure and operation in relation to the EU medicines regulatory network, its partners and stakeholders.

• 

  David Haerry

  • Co-Chair Advisory Committee
  • EUPATI Foundation,European AIDS Treatment Group, Belgium

  David has been involved with providing input to R&D from a patient perspective for more than 20 years. He has played an active role in the European Patients’ Academy on Therapeutic Innovation (EUPATI), and currently co-leads their external Advisory Committee. He is a past co-chair of the Patient and Consumer Working Party at the European Medicines Agency.Currently, is involved with Swissmedic’s Patients and Consumer Working Group, and he is a member of the PFMD Executive Committee, of the Zurich Cantonal Ethics Committee and the Impact Council for Gilde Healthcare. As a past member of the DIA Regional Advisory Council for EMEA, he was awarded the Outstanding Contribution to Global Health award in 2019.

• 

  Martin Harvey Allchurch, LLM

  • Head of International Affairs
  • European Medicines Agency, Netherlands

  Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.

• 

  Ralf Herold, DrMed, MD

  • Head of Regulatory Science and Academia Workstream (ad interim)
  • European Medicines Agency, Netherlands

  Ralf is a Senior scientific officer in the Regulatory Science & Innovation Task Force of the European Medicines Agency, Amsterdam, responsible for Horizon scanning, Academia liaison and Regulatory science project involvement. Previously, he worked with stakeholders on Oncology, Haematology & Diagnostic as well as Paediatric medicines, starting 2007 at the Agency. Ralf was the Pediatric development leader of Bayer AG, Regulatory affairs (2017 to 2018). At Humboldt University in Berlin, Germany, he obtained an experimental research PhD, board-certified in 2004 in paediatric and adolescent medicine, trained in Paediatric oncology and haematology, and managed a publicly-funded national clinical research network.

• 

  Anette Hjelmsmark, MS

  • Senior Regulatory Intelligence Manager
  • Novo Nordisk A/S, Denmark

  Ms. Anette Hjelmsmark holds a position as Senior Regulatory Intelligence Manager at Novo Nordisk A/S headquarters. In her current capacity she leads Novo Nordisk Regulatory Affairs’ efforts on regulatory intelligence and advocacy in China. Before this she spearheaded similar activities in the EU. ATMPs as well as siRNAs are new areas of involvement. She currently chairs the EFPIA China Regulatory Network, is a member of the EFPIA International Regulatory Expert Group covering various regions and countries as well as a member of the EFPIA ATMP SG. Anette is a faculty member at the University of Copenhagen Master of Industrial Drug Development and holds a MSc. from the Royal Veterinary and Agricultural University in Copenhagen, Denmark

• 

  Ian Hudson

  • Senior Advisor, Integrated Development
  • Bill and Melinda Gates Foundation, United States

  Dr. Ian Hudson has a leading role on the team in areas that include optimizing clinical studies and strengthening regulatory systems in Africa and other low-resource regions, particularly for malaria, polio, and COVID-19 drugs. Ian was a practicing pediatrician before joining SmithKline Beecham in 1989 to work in research and development. In 2001, he joined the UK government’s MHRA, where he served as director of licensing and then CEO. Ian was the UK delegate to the scientific committee of EMA’s Management Board, CHMP, later becoming its vice chair. He was also an honorary senior lecturer in clinical pharmacology at the University of London and served as chair of the International Coalition of Medicines Regulatory Authorities.

• 

  Christophe Lahorte

  • Head of National Innovation Office and Scientific-Technical Advice Unit
  • Federal Agency for Medicines and Health Products, Belgium

  Dr. Christophe Lahorte, PhD. performed academic research for 6 years at the Gent University. Since 2004 he has been actively involved within the R&D department of Belgian agency for medicines and health products (FAMHP) in the quality assessment of CTA’s and PIP’s. In 2009, Dr. Lahorte was appointed as head of the FAMHP’s Unit for National Scientific-Technical Advice & Knowledge Management. In 2017, he became the Head of the FAMHP’s National Innovation Office which aims to support and guide all types of innovators developing new innovative drug products and medical technologies in Belgium and Europe. In addition, he is actively involved in several European projects coordinated by the EMA and European Commission including the ACT EU.

• 

  Fadila Lakkis

  • Regulatory Affairs, Intelligence & Communications Manager, Gulf
  • GSK, United Arab Emirates

  Fadilla has over 12 years of experience in Pharma Industry transitioning from Sales, to Global Policy and Intelligence till reaching Regional Regulatory Affairs. She is the Vice Chair of EFPIA Middle East Regulatory Network (MERN) since end 2021 and an active member in PhRMA Gulf Regulatory Affairs Working Group (RAWG). She holds bachelor’s degree of Pharmacy from the Lebanese International University & MBA degree from the American University of Science & Technology in Lebanon.

• 

  Susanne Norskov, MPharm

  • EFPIA ICH E6(R3) Expert Working Group Member
  • Denmark

  Susanne Nørskov is a pharmacist with 30 years of experience within the industry at a global level. Her interest includes drug development focused on clinical research specifically within quality and compliance. Since 2019 she has been the deputy EFPIA topic lead on the ICH E6(R3) update. Currently, Susanne is holding a position as a scientific Vice President in the Global Clinical Compliance, R&D Quality in Novo Nordisk A/S. She is based in Copenhagen.

• 

  Chelsea O'Connell, MS, RAC

  • Director, Global Regulatory Policy & Intelligence
  • Amgen, United States

  Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory Policy & Intelligence Director, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various policy topics. Before joining Policy, she led regulatory teams and developed filing strategies across various therapeutic areas and product presentations including companion diagnostics, combination products, and software. Prior to joining Amgen, she worked for ophthalmic and cardiac medical device companies. She earned a B.S./M.S. from California Polytechnic State University, San Luis Obispo in Biomedical Engineering.

• 

  Magdalini Papadaki, PhD, MBA, MSc

  • Director, Regulatory Affairs International
  • MSD, United Kingdom

  A cell and gene therapy scientist with over a decade regulatory and business experience in the EU and US. She joined MSD from the ABPI as Head of Product & Process Innovation. Magda’s experience includes Innovate UK, the MIT Center for Biomedical Innovation and Regulatory Affairs Director at Novartis Greece and Cyprus. Specialises on the development of partnerships to reshape the HA and HTA assessment of novel treatments and was member of the global consortium developing the Adaptive Pathway paradigm in MIT. She holds a PhD in Gene Therapy from the Un. of Athens, an MPhil in Bioscience Enterprise from the University of Cambridge, UK and MSc in Pharmacology from the University of Oxford.

• 

  Leonardo Semprun, PharmD

  • Global Regulatory Policy Lead-LatAm
  • MSD, Panama

  Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with LATAM-based regulators and multilateral organizations. He has worked with governments, regulators, trade bodies and other external stakeholders to shape regional regulatory policy. Leonardo' work in the industry spans over 20 years, across regulatory, quality, intellectual property and policy functions

• 

  Nick Sykes, MS

  • Policy Advisor
  • EFPIA, Belgium

  Nick is a Policy Advisor for Regulatory Strategy at EFPIA. Nick’s current focus is on the revision of the general pharmaceutcal legislation, regulatory aspects of the Innovative Health Initiative (IHI), and the interface between the drug, device and diagnostics legislative frameworks in the EU. Prior to working at EFPIA, Nick spent 25 years at Pfizer within their Global Regulatory Sciences team. His last role in Pfizer was as Head of Europe and International Regulatory Policy. In this role he was also Co-Chair of EFPIA's Regulatory Strategy Committee. During 2019 Nick was President of TOPRA and Chairman of TOPRA's Board of Directors. Nick has a graduate degree in Genetics/Microbiology and a master’s degree in Information Science

• 

  Francisca Vaz

  • Senior Specialist, QA Release Coordinator,
  • Moderna, Switzerland

  Francisca is currently Quality Assurance Coordinator at Moderna. She is responsible for batch disposition and release for distribution to global markets. Her previous experience was in the medical cannabis field for 2 years, as a project manager and QA manager. She supported the design of a GMP facility, production procedures, developed the QMS and QA procedures, managed qualification and validation services. Francisca holds a Master’s degree in Pharmaceutical Sciences since 2017.

• 

  Nadege Le Roux, PhD

  • Regulatory Policy Senior Director
  • Bristol Myers Squibb, Switzerland

  As Senior Director of Regulatory Policy and Intelligence at BMS, Nadège is leading taskforces to evaluate the European regulatory framework in the perspective of global environment. She works with stakeholders to advocate for policies supporting development of innovative medicines and regulatory systems. She has worked in the pharmaceutical industry for over 20+ years and is currently focused on regulatory policies relating to the European pharmaceutical legislative ecosystem to advance innovation, orphan drug development, patient engagement as well as the modernization of the regulatory procedures via digitalisation.

• 

  Nevena Miletic

  • IFPMA ARN Chair Advisor and Regulatory Policy & Science Chapter Leader
  • F. Hoffmann-La Roche Ltd, Switzerland

  Nevena Miletic is a pharmacist, with postgraduate studies in parmacoeconomics, Reg Affairs and QA, with more than 18 years of experience in pharma industry. Currently she works in Global Regulatory Policy at F. Hoffmann-La Roche and for the last five years, she is co-chairing IFPMA Africa Regulatory Network and CPP Network. She is also a member of IFPMA Regulatory Science and Africa Engagement Committees, DIA MEA Advisory Board, EFPIA ERAO PI WG, IATF etc., being involved in numerous projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, ICDRA, IMI, SCoMRA etc.). Nevena is a strong advocate for regulatory convergence and harmonisation, with main interest in innovative approaches in drug development and review.

• 

  Claus Bolte, DrMed, MBA

  • Head of Authorisation
  • Swissmedic, Switzerland

  Claus Bolte currently serves as the Sector Head for “Marketing Authorization” and Management Board member at Swissmedic, the independent Swiss life sciences regulator. Claus joined Swissmedic 2012 to initially head their Clinical Review division. Prior to that, Claus had roles of increasing responsibilities with research-based international pharmaceutical, biotech and medical device organisations (UK, USA, CH). Claus trained as a General Surgeon and had clinical and academic appointments in Trauma, Transplant and Oncologic Surgery.

• 

  Emer Cooke, MBA, MSc

  • Chair, ICMRA; Executive Director
  • European Medicines Agency, Netherlands

  Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to support the development and approval of safe and effective COVID-19 vaccines and treatments.” Doing precisely that has since earned her various accolades including an Honorary Doctorate for outstanding contribution to healthcare (RCSI - 2023) and the ‘European of the Year 2022’ title by European Movement Ireland. Ms Cooke obtained a degree in pharmacy and master’s degrees in both Science and Business Administration from Trinity College in Dublin, Ireland.

• 

  Arie Gafson

  • Head of Personalized Medicine R&D for Digital Health
  • Biogen, Switzerland

  Arie Gafson leads Personalized Medicine within Biogen Digital Health. He is a neurologist by background, having trained in the UK. He did his MD at Oxford/UCL and then his PhD and clinical training at Imperial College, London.. Arie’s group at Biogen utilizes Biogen’s rich internal datasets to drive new insights into neurological diseases using ML/AI, in particular MS, Alzheimer’s and Parkinson’s Disease. The goal is to generate discoveries that can optimize Biogen’s clinical development plans and patient management through personalized medicine.

• 

  Modupe Adeyemo

  • South Africa

• 

  Grigorios Agkyralidis, MSc

  • Head of Regulatory Affairs
  • BOEHRINGER INGELHEIM HELLAS Single Member SA, Greece

  Grigorios Agkyralidis is a Pharmacist with a Master’s Degree in Industrial Pharmacy (University of Athens). He has almost 20 years of working experience in the Pharmaceutical Industry mainly focused in the fields of Regulatory Affairs and Pharmacovigilance. His current business position is Head of Regulatory Affairs in Boehringer Ingelheim Greece with responsibilities for Greece and Cyprus. He has authored scientific and business articles and given many lectures mainly in Greece and Cyprus. He is also an active member of the Regulatory Affairs Working Party of the local Pharmaceutical Industry Association (SFEE)and has been recently assigned as coordinator of the Greek Association for Pharmaceutical Medicine (ELEFI) for Regulatory Science.

• 

  Scott Askin, MSc

  • Global Program Regulatory Director
  • Novartis Pharma AG, Switzerland

  Currently working in the area of Regulatory Affairs for Novartis, Scott has over 20 years of industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to his current role in Regulatory Affairs Policy, Scott led several of Novartis’s digital innovation projects. Since his transition into Regulatory, Scott continues to advise digital program teams internally in areas such as eConsent, eSource, Decentralized Clinical Trials, Blockchain & AI, and collaborates externally in several cross-industry initiatives.

• 

  Cristina Baccarelli, MSc

  • GMP Inspector
  • European Directorate for the Quality of Medicines and Healthcare (EDQM), France

  MSc in Chemistry from the Univ. of Rome, Cristina Baccarelli worked 4 years as R&D Scientist for a pharmaceutical company in the UK, developing GMP manufacturing processes & analytical methods. Returned to Italy to do post-graduate research work in the field of Biochemistry & Cell Biology. She joined the Italian Medicines Agency in 2007, where for 12 years she performed national & international API GMP inspections and coordinating registration activities of API manufacturers according to the EU legislation requirements. In 2019 she joined EDQM as GMP Inspector and has been involved in several international groups on APIs with the role of Italian, European Union, EDQM delegate, including EMA, ICH, European Commission and PIC/s expert groups.

• 

  Liese Barbier, PharmD, MS

  • Postdoctoral researcher
  • KU Leuven, Belgium

• 

  Cedric Berger, PhD, MBA

  • Head of Knowledge Extraction and Integration
  • F. Hoffmann-La Roche, Switzerland

• 

  Henrik Bjorklund

  • Associate Professor
  • Department of Computing Science, Umea University , Sweden

  Henrik Björklund holds an MA in Literature and a PhD in Computer Science, both from Uppsala University, Sweden. After working six months at the RWTH Aachen and 3.5 years at the TU Dortmund, he joined Umeå University, where he now works as an Associate Professor at the Department of Computing Science. Björklund’s research interests span the width from Theoretical computer science to Natural language processing. In recent years, he has taken a particular interest in questions about social biases in language modelling systems.

• 

  Christelle Bouygues, PharmD

  • Regulatory Affairs Senior Officer
  • European Medicines Agency, Netherlands

  Regulatory Affairs Senior Officer at the European Medicines Agency. Joined the EMA in 2004. Responsible for providing regulatory intelligence and advice in relation to the development, evaluation and surveillance of medicinal products for the Centralised Procedure. Involved in particular with the implementation of the paediatric and pharmacovigilance legislation. Currently, amongst other projects, closely involved in the implementation of the MDR/IVDR within EMA as regard to the aspects on medical devices used in combination with medicinal products and on the repurposing pilot. Before joining the Agency, gained experience at the French Competent Authority, in the Mutual Recognition Procedures and in the Industry.

• 

  Gabriele Breda, PhD

  • Research & Innovation Director
  • ProductLife Group, France

  Gabrièle Breda is the Director of Research & Innovation at ProductLife Group (PLG). Graduated from Ecole Normale Supérieure of Paris, with a PhD in Neurosciences, Gabrièle has been managing collaborative Research & Innovation in Healthcare Engineering at Altran and Capgemini Engineering for 12 years. Since 2022 she is developing Research & Innovation at PLG to address the main Life Sciences evolutions and challenges brought by digital transformation and technological innovation, with perspectives to regulatory science and shared value.

• 

  David Brown, MSc

  • Head of Statistics Team, Healthcare, Quality and Access
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

  David Brown is the head of the Statistics team at the MHRA. He has over 20 years’ experience as a statistical assessor at the MHRA, and prior to Brexit was a member of both the biostatistics working party and scientific advice working party at the EMA. He was part of the group that formulated the recently published MHRA guidance on real-world data.

• 

  Lisa Charlton

  • Senior Director, Product Development, eCO
  • Science 37, United States

  Lisa Charlton has ten years of experience in eClinical technology with an emphasis on eCOA solutions. Her career within the industry started in supporting consulting work for COA instrument development, linguistic validation, and regulatory interactions and then followed with a focus on eCOA implementation and process improvement. For the past two years, Lisa has led product development for participant solutions including ePRO, eConsent, and a participant portal. Lisa earned her PhD in Biological Chemistry from UNC and her MBA from Point Park University.

• 

  Fabio D’Atri

  • Policy Officer, Deputy Head of Unit
  • Unit B5 Directorate General for Health and Food Safey, European Commission , Belgium

  Fabio has a PhD in biochemistry and a master’s in management of biotech companies. After working several years as a university researcher, both in the public & private sector, he joined the EU Commission in 2004 where he has worked in several areas of the food legislation, from nutrition to food contact materials. In 2011 he joined the units dealing with pharmaceutical products in DG SANTE. He has worked on quality of medicines, falsified medicines and clinical trials. During 2016 & 2017 Fabio was seconded to the European Centre for Disease Prevention and Control (ECDC) in Stockholm and worked in particular on vaccination & antimicrobial resistance related issues. He has been in charge of the paediatric medicines file since late 2018.

• 

  Claudia Dollins, PhD, RAC

  • Vice President, Precision Medicines, Global Regulatory Affairs
  • GlaxoSmithKline, United States

  A geneticist by training, Claudia Dollins served in regulatory leadership roles located both in the USA and Europe. She held multiple roles of increasing responsibility in US FDA’s CDRH/Office of In Vitro Diagnostics and Radiological Health before transitioning to the pharmaceutical industry. In prior pharmaceutical industry roles, she has built global Digital Health, Companion Diagnostics, Medical Devices, and Combination Product Regulatory organizations within Merck Healthcare KGaA and Bristol-Myers Squibb. She is currently the VP, Precision Medicines, Global Regulatory Affairs at GSK.

• 

  Katherine Donegan

  • Head of Epidemiology
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

  Katherine Donegan holds a PhD in statistics and spent 4 years working for the UK Medical Research Council in HIV research, working with both clinical trial and observational data. She joined the MHRA in 2010 and having now been there over 13 years, Katherine leads their epidemiology team working closely with partners across the Agency to advise on the value of observational studies and to develop strategy on the use of real world data to support regulation. She has particulalr interests in the use of RWE to support pharmacovigilance, vaccines safety, and the role of observational data in evaluating the safety of medical devices.

• 

  Marwan Fathallah, MBA, MSc

  • President & Chief Executive Officer
  • DIA, United States

  Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.

• 

  Giovanna Ferrari, PhD

  • Regional Labelling Lead, Senior Director
  • Pfizer Ltd, United Kingdom

  Giovanna Ferrari is a Senior Director at Pfizer with over 15 years’ experience working in the regulatory sector of the pharmaceutical industry, specialising in labelling & product information since 2009. She currently works within the Pfizer International Labeling Group with regional responsibility for Europe and is also the global business owner for the Pfizer process for management of country labeling documents. Externally, Giovanna has represented Pfizer in a wide range of industry forums over the last few years, in particular focussing on e-labelling, and is the industry lead for a highly innovative and patient-focussed digital health information project that is being progressed via an IMI public-private partnership – Gravitate Health

• 

  Barbara Freischem, DVM

  • Head of Veterinary Surveillance and Regulatory Support Department
  • European Medicines Agency, Netherlands

  Barbara Freischem is the Head of the Department ‘Veterinary Surveillance and Regulatory Support’ in the Veterinary Division of the European Medicines Agency. Her responsibilities include regulatory support to the Division, pharmacovigilance activities for veterinary medicines, and the monitoring of sales data for veterinary antimicrobials. Before rejoining the EMA in 2019, Barbara worked in different roles linked to regulation of mostly veterinary medicines at national, European and international level, both on the side of regulatory agencies and on the side of industry. Barbara has a degree in Veterinary Medicine from the Free University of Berlin.

• 

  Yasuhiro Fujiwara, MD, PhD

  • Chief Executive
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was a deputy director of the Evaluation Division II of PMDEC, later merged with other organization to form PMDA of the Ministry of Health and Welfare and Labor between 1997 – 2002, making his current position as Chief Executive his second appointment. Between Jan 2011 to Feb 2013, he was a Deputy Secretary General of Office of Medical Innovation, Cabinet Secretariat of Japan, and led health policy issues regarding life science.

• 

  James Gallagher

  • Team Leader
  • Janssen Clinical Innovation, Switzerland

  James leads a team of innovation experts serving all Global Development functions and all therapeutic areas within Janssen Pharmaceuticals, JnJ. One key strategic program the team are currently working on is ‘environmental sustainability’ to better understand the current impact and set appropriate targets moving forward.

• 

  Kenneth Getz, MBA

  • Tufts Center for the Study of Drug Development
  • Tufts University School of Medicine, United States

  Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken also holds a number of board appointments in the private and public sectors. He received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.

• 

  James Griffiths

  • Team Leader for Integration Services
  • Veeva Systems, United Kingdom

  James Griffiths is a Team Leader for Integration Services at Veeva Systems. With over 10 years in the life sciences software industry, James has been working with customers to transform how software applications communicate by applying industry best practices and in-depth process knowledge to create seamlessly integrated application landscapes. His academic and professional background is in software engineering, computer systems and consulting. James has been leading multi-skilled technical teams who specialise in system integration and data migrations in commercial content, CRM, Medical and more recently, Safety.

• 

  Hilmar Hamann, PhD

  • Head of Information Management
  • European Medicines Agency, Netherlands

  Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the future. Prior to joining EMA, from 2011 to 2020, he served as the Director for Business Informatics at the U.S. Food and Drug Administration leading the transformation of medicines regulatory data, advancing data analytics, and modernizing the scientific computational and collaboration platforms that underpin operations.

• 

  Niklas Hedberg, MPharm

  • HTACG Co-Chair & Chief Pharmacist
  • Dental and Pharmaceutical Benefits Agency, TLV, Sweden

  Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and reimbursement since 2001. Niklas started as a medical assessor and project leader in the agency, he was the Head of the Department for New Submissions between 2009 and 2014 and is since in his current position. Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making.

• 

  Nasir Hussain, PhD, MBA

  • Associate Director of Regulatory Policy & Intelligence
  • Gilead Sciences, United Kingdom

  • Representing Gilead on EU Trade Associations [EFPIA (Dynamic Regulatory Assessment WG), PhRMA (Paediatric WG), EUCOPE (Regulatory Affairs WG)] generating company positions, influencing plans & bridging with senior management teams •Identifying regulatory, competitive and legislative trends and issues impacting Gilead's products and development pipeline • Leading and implementing strategic and operational plans for pharmaceutical regulatory intelligence database and alerting systems, tracking and internal stakeholder communication • Facilitating workshops & internal consultations to regulatory call for comments on guidance, policies & legislative documents from EC, EMA, MHRA and other National Competent Authorities

• 

  Lars Hyveled-Nielsen, MPharm

  • Regulatory Project Director
  • Zealand Pharma, Denmark

  Employed in the pharmaceutical industry for 30 years and in Regulatory Affairs for more than 20 years. Been working for Small and Medium Sized Enterprises as well as large established companies (LEO Pharma and Novo Nordisk), driving drug development and drug-device combination products as the regulatory lead. Have both been developing disposable single integral drug-device combination products and reusable drug-device combination products. Liaised with multiple health authorities around the globe with focus on EU and US. Heading up the EUCOPE (trade organization for Small and Medium Sized Enterprises) focus group for drug-device combination products and liaise with EMA on the the topic ‘integrated pathway for drug-device combination’.

• 

  Veronika Jekerle, PhD, RPh

  • Head of Pharmaceutical Quality
  • European Medicines Agency, Netherlands

  Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation. A pharmacist by training, she joined European Medicines Agency in 2006 as a Product Team Leader for Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. She held various positions including Quality Specialist and Scientific secretary for the Biologics working party and coordinated several guidelines in the area of Biologicals, ATMPs and vaccines as well as PRIME toolbox guidance and prior knowledge.

• 

  Evangelos Kotzagiorgis, MPharm, MS

  • Pharmaceutical Quality Senior Specialist, Pharmaceutical Quality Office, Human M
  • EMA, Netherlands

  Evangelos is a Qualified Pharmacist and has got an MSc on Pharmaceutical Analysis and Quality Control from the University of Athens, Greece. He has joined the European Medicines Agency (EMA) in 2005. Currently he works as Quality Senior Specialist in the Quality of Medicines Office providing scientific support in the evaluation of new products, and in Scientific Advice requests. Evangelos is also involved in the work of the EMA Quality Working Party and Biologics Working Party and in the development of scientific guidelines. He has previously worked in Industry in R&D and gained experience in pharmaceutical development, manufacturing and quality control.

• 

  Niels Buch Leander, PhD

  • Vice President, R&D
  • NNIT, Denmark

  Niels Buch Leander is leading Regulatory Affairs and Safety at NNIT, responsible for NNIT's delivery and business development within Regulatory Affairs and Safety. He is revenue responsible for 100+ consultants and people management responsible for 40+ RA and Safety business consultants across Switzerland, Germany, Denmark, Polen and UK. Regulatory Affairs reports to NNIT's Board of Directors as one of NNIT’s 10 strategic “Winning Solutions”.

• 

  Olivier Luttringer

  • Global Head, Advanced Quantitative Evidence, Global Medical Affairs
  • Novartis, Switzerland

• 

  Neil McAuslane, PhD, MSc

  • Director
  • Centre for Innovation in Regulatory Science (CIRS), United Kingdom

  Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology from the University of Edinburgh and an MSc from Surrey University in Toxicology.

• 

  Vishal Mehta

  • Head of Life Sciences Go-to-Market EMEA at ServiceNow
  • ServiceNow , Switzerland

  Vishal Mehta is a seasoned technology professional with a wealth of experience in the software industry. He currently serves as the Head of Life Sciences Go-to-Market for ServiceNow in the EMEA region, a leading cloud-based platform that helps organizations manage digital workflows. With over 20 years of experience in the software industry, Mehta has a proven track record of success in driving business growth, building high-performing teams, and delivering innovative technology solutions to customers. He is known for his deep understanding of software development, product management, and customer experience, as well as his ability to develop and execute effective go-to-market strategies.

• 

  Raul Mora, MSc

  • Senior Strategic Operational Intelligence Head
  • Hoffmann-La Roche, Switzerland

  Process improvement professional, with 15 years experience in (re) design of processes including optimisation and modernisation of processes, prototyping of new solutions and scale up to industrial/global roll out, assessment of maturity models, including development of improvement roadmaps, auditing, compliance and stewardship of regulated processes. Experience in Specialty Chemicals, Power generation, Oil & Gas and Pharma industries across manufacturing/operations, maintenance, supply chain, field service, Quality & EHS, Operational Excellence functions and a proven rate of successful project implementations.

• 

  Ritu Nalubola, PhD

  • Director, FDA Europe Office
  • FDA, Belgium

  Dr. Ritu Nalubola is the Director of FDA Europe Office, located within the U.S. Mission to the EU in Brussels, Belgium. Prior to taking on this role in 2018, she served as a Senior Policy Advisor in FDA’s Office of Policy in the Office of the Commissioner, where advised senior leadership at FDA, HHS, and other U.S. government agencies on complex and cross-cutting policy issues, including related to biotechnology, nanotechnology, food safety, nutrition, international standards, and trade-related matters. Most recently, Dr. Nalubola was the primary lead for FDA’s efforts to modernize the regulatory system and facilitate innovation in biotechnology products. She started her FDA career at CFSAN in 2001.

• 

  Handan Öztunca

  • Head of Marketing Authorization Department
  • Turkish Medicines and Medical Devices Agency (TITCK), Turkey

  She graduated from Hacettepe University, Faculty of Pharmacy and hold M.Sc degree in Pharmacognosy from the same University. She had worked in Department of Biological Products, as unit supervisor in Marketing Authorization Department, Biological and Biotechnological Products Unit and at the same time as a member in Biotechnological Quality Assesment Commision in Turkish Medicines and Medical Devices Agency (TITCK). Between 2018-2021, she worked as the Head of Herbal and Supplementary Products Department. As of August 2021, she was appointed as the head of Department of Marketing Authorization and continuing in this position since than.

• 

  Lykke Pedersen, PhD

  • Head of RNA THerapeutics
  • Abzu, Denmark

  Lykke was awarded her PhD in Biophysics from the University of Copenhagen and conducted research at the Niels Bohr Institute. Her experience as a bioinformatician coalesced at Roche, where Lykke worked as Lead Drug Designer across multiple projects with drug candidates entering clinical trials. She is an inventor on more than 40 patents in the field of RNA Therapeutics. Today she works as Head of RNA Therapeutics at Abzu. She is still working in the emerging field of RNA therapeutics. Today, she helps discover medicines for previously untreatable diseases, like Alzheimer’s, various cancers, and neurodegenerative diseases. She is also passionate about women-in-tech. Her philosophy centers around encouraging women to be their absolute best.

• 

  Ana Maria Rodriguez Leboeuf Rodriguez, PhD, MPH, MSc

  • Director, Preference Practice Lead, Patient Centered Solutions
  • IQVIA, Spain

• 

  Joseph M Rymsza

  • Vice President, Global Safety, Regulatory and Quality Technology Solutions
  • IQVIA, United States

  Joe Rymsza is VP of Global PV, Regulatory and Quality Technology Solutions. He has over 25 years of experience in developing, deploying and managing technology solutions in the life sciences industry. In his current role, he oversees IQVIA’s efforts to harness the power of cutting-edge technology for managing regulatory compliance. Prior to IQVIA, Joe was co-CEO of Foresight Group International, a professional services group focused exclusively on drug safety and risk management. Joe has also served as the CEO of Vettro, a mobile technology provider for the life sciences industry, and as Executive Director of professional services firm Cysive.

• 

  Khushboo Sharma, MBA

  • Chief Regulatory Innovation Officer
  • Accumulus Synergy, United States

  Khushboo Sharma is the Chief Regulatory Innovation Officer for Accumulus. Sharma joined Accumulus Synergy in 2022 from BIO, where she focused on major regulatory policy initiatives to build the appropriate regulatory framework. Prior to BIO, Sharma spent 11 years in various roles at the FDA, including Deputy Director of Operations in the Office of New Drugs. While at the FDA, Sharma oversaw business, regulatory, and programmatic operations, supported regulatory review for the New Drugs Regulatory Program through the New Drugs Modernization effort, and served as an FDA negotiator during PDUFA negotiations. She earned her bachelor’s degree in biotechnology and MBA Biotechnology and Healthcare Industry Management from Penn State University.

• 

  Hiiti Sillo, MSc, RPh

  • Unit Head, Regulation and Safety, Department of Regulation and Prequalification
  • World Health Organization (WHO), Switzerland

  Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until August 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS), Regulation and Safety Unit. Before joining WHO in January 2018, he was the Director General of the Tanzania Food and Drugs Authority (TFDA). Mr. Sillo is a pharmacist with extensive experience in regulation of medical products at the national, regional and global levels.

• 

  Andrew Thomson, PhD, MA, MS

  • Statistician, Methodology Taskforce
  • European Medicines Agency, Netherlands

  Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat of the Methodology Working Party. He also is the lead of the Statistics subgroup of ICH E11A on paediatric extrapolation, sits on ICH E6 R3 Annex 2 group, and is the Regulatory Chair of both groups. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

• 

  Christine van Hattem, MSc

  • PhD candidate
  • Utrecht University, Netherlands

  Christine van Hattem is a PhD student at the Utrecht Institute for Pharmaceutical Sciences (Utrecht University) in the Netherlands. Christine obtained a BSc in Biomedical Sciences and a MSc in Drug Innovation at Utrecht University. During her studies she developed a special interest in the (pre-)clinical and regulatory aspects of developing novel medicinal products. As such, her PhD project focuses on the regulation of and ultimately improving patient access to Advanced Therapy Medicinal Products (ATMPs), as part of DARE-NL, a national platform for gene- and cell therapies. Her presentation at DIA Europe results from a collaborative project with her colleagues from Utrecht University.

• 

  Effy Vayena

  • Deputy head of Institute of Translational Medicine
  • Swiss Federal Institute of Technology, Switzerland

• 

  Wija Oortwijn, PhD, MSc

  • Senior Scientific Researcher, Department for Health Evidence
  • Radboud University Medical Centre, Netherlands

  Wija Oortwijn studied health sciences and holds a PhD in Medicine. Since 1993, she has been involved in the development of HTA & health system strengthening around the world, including Abu Dhabi. Currently, she is affiliated at Radboud University Medical Centre in the Netherlands. She is working with Ministries of Health, the European Commission, World Bank, and WHO on institutionalizing HTA mechanisms for legitimate coverage decision making and capacity building in HTA. She is the President of HTAi, the international Society for HTA, as well as associate editor of the International Journal of Technology Assessment in Health Care.

• 

  Michael Berntgen, PhD

  • Head of Scientific Evidence Generation
  • European Medicines Agency, Netherlands

  Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

• 

  Stephen Duffield

  • Senior Analyst
  • National Institute for Health and Care Excellence (NICE), United Kingdom

  Stephen’s role involves the continuing development of NICE’s real-world evidence (RWE) framework, collaboration on RWE demonstration projects, and helping to transform NICE’s use of real-world data across guidance products. He is also involved with upskilling individuals within and externally to the organisation, contributing to training workshops and technical forums. Stephen has a degree in medicine and a PhD in public health. Previously, he worked as a clinical doctor and a guideline developer in NICE Centre for Guidelines.

• 

  Giulia Gabrielli

  • Netherlands

• 

  Aleksandra Opalska

  • Policy Officer
  • European Commission - DG SANTE, Belgium

  Aleksandra Opalska is a policy officer at the European Commission in the Directorate-General for Health and Food Safety in the unit responsible for medicines: policy, authorisation and monitoring. She works on antimicrobial resistance, COVID-19 pandemic and pharmacovigilance related activities. She is a pharmacist by training.

• 

  Mark Turner, MD, PhD, MRCP, FFPM

  • Chief Executive Officer of the c4c- Stichting (c4c-S) & Professor of Neonatology
  • University of Liverpool, United Kingdom

  Neonatologist with a special interest in early phase drug development and improving the availability of high quality medicines to children and babies. Has studied 20 medicines in neonates and pregnant women including antibiotics, excipients, treatments for in utero growth restriction, inotropes, postnatal steroids and surfactant. Current work is focused on developing research infrastructure for pediatric medicines research in Europe and beyond.

• 

  Aris Tzavaras

  • Head of Notified Body Artificial Intelligence
  • BSI Group, Netherlands

  Dr. Aris Tzavaras is the Head of Artificial Intelligence Notified Body in BSI group. He has worked as BSI Senior Technical Specialist and Scheme Manager within the Active Medical Devices team at BSI. As part of his work as Technical Specialist, he has reviewed MDR and MDD active devices including AI software devices. He has more than 20 years’ experience in Medical Devices including Academic lecturing for BSc and MSc Biomedical Engineering programs. He holds a PhD in Health Informatics from City London University on Artificial Intelligence.

• 

  Padraic Ward

  • Head of Roche Pharma International
  • Roche, Switzerland

  Padraic Ward, Head of Commercial Operations for Roche Pharma International (all markets ex-US) and a leading member of the Pharmaceutical Leadership Team, is committed to improving healthcare outcomes for patients. He joined the company in 2004 and has worked in a number of key roles including leading the team bringing a new medicine for breast cancer through the final stages of development and regulatory approval, and leading the commercial organisation first in France and then in Europe. He was appointed to his current role as Head of Commercial Operations for Roche Pharma International in June 2018. Padraic holds a Bachelor of Commerce degree from the University College Dublin and an MBA from INSEAD.

• 

  Lauren Abrey

  • CMO
  • inCephalo, Switzerland

  Dr Abrey is a physician-scientist with more than 25 years of experience in clinical research, drug development, translational oncology, business development, medical affairs, and regulatory interactions. She is a recognised international expert in the fields of neurology and oncology who brings a unique perspective to drug development following her academic career and clinical practice at Memorial Sloan Kettering Cancer Center. Dr Abrey held leadership positions in Oncology at both Roche and Novartis prior to joining InCephalo Therapeutics.

• 

  Hiroyuki Arai, PhD

  • Executive Director
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  Dr. Hiroyuki Arai has served as an Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) since April 2020. Before joining PMDA, he was a professor of Department of Health Chemistry, Graduate School of Pharmaceutical Sciences at the University of Tokyo (2000-2019). He also served as a dean (2016-2018) there. He graduated in 1979 and received his PhD (Biochemistry) in 1984 from the University of Tokyo. His overseas experience includes the University of Illinois (1984-1986) and Tufts University School of Medicine (1986-1988).

• 

  Stephanie Croft

  • Technical Officer
  • World Health Organization, Switzerland

  Stephanie Croft is a Chemist by training and currently working with WHO as a Technical Officer in the Inspection Services Group of the consolidated WHO Prequalification Team for Medicines, Vaccines, Devices and Diagnostics and Vector Control products.Experienced in GMP, GCP, GLP and ISO Regulatory Inspections with over 8 Years of onsite inspections at the international level. With Health Canada’s Bureau of Pharmaceutical Sciences, was an assessor of the quality of generic medicines. Has conducted over 100 inspections in 35 countries such as India, China and France.

• 

  Joan D'souza, JD

  • Pharmacovigilance Physician/Medical Reviewer/LPPV Switzerland, Germany, and Liec
  • Pharmacovigilance Physician/Medical Reviewer/Lppv Switzerland, Germany, and Liec, Switzerland

  Dr. Joan D'souza has pre and post-marketing safety surveillance experience. A firm believer in sharing her knowledge: The International Society of Pharmacovigilance (ISoP), Global Pharmacovigilance Society, American Medical Writers Association, European Medical Writers Association, and Pharma International Conferences in Europe are just a few of the many venues in which she has spoken. She has worked for various clinical research organizations and pharmaceutical companies. Her treatment experience includes oncology, dermatology, pain management, infectious disorders, vaccines, and diabetes.

• 

  Kelly M. Dumais, PhD

  • Director, eCOA Science and Consulting
  • Clario, United States

  Kelly is a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She consults on best practices for questionnaire design and eCOA use to drive data integrity and patient engagement, and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.

• 

  Helen Edelberg, MD, MPH, FACP

  • Deputy Office Director for Safety, Office of New Drugs
  • FDA, United States

  Dr Helen Edelberg is a strategic & innovative regulator, physician, and former biopharmaceutical executive whose passion is to ensure patient safety & promote public health by building bridges among interconnected stakeholder groups, integrating the complementary strengths of each individual to achieve high performance and engagement, and introducing new product and organizational opportunities that strengthen enterprise reputation & position. She brings 20+ years of leadership experience in global & corporate Regulatory Affairs/Pharmacovigilance and academic medicine/clinical practice in Internal Medicine/Geriatrics. In her current role, she collaborates closely with colleagues in OND/CDER to integrate & advance postmarket safety efforts.

• 

  Inci Ergönül

  • Head of Clinical Trials Department
  • Turkish Medicines and Medical Devices Agency (TITCK), Turkey

• 

  Sini Eskola, MPharm, MS, MSc

  • Director Regulatory Strategy
  • EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

  Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.

• 

  Melissa Estevez, MS

  • Senior Quantitative Scientist
  • Flatiron Health, United States

  Melissa is a Senior Quantitative Scientist at Flatiron Health where she focuses on the application of machine learning to real world data. Specifically, Melissa brings expertise in the underlying data and downstream analytic use cases to support development of machine learning based solutions, evaluate model performance and guide downstream use of machine learning derived data.

• 

  Marco Farinelli, PhD, MSc

  • Markets Supply Lead (MCAM)
  • AstraZeneca; Chair of the Supply Chain WG at EFPIA, Italy

  Marco has more than 15 years of experience in the pharmaceutical sector and works in the Global Supply Chain and Strategy function of AstraZeneca where he is responsible on all aspects related to market supply into a group of European Countries across the whole company portfolio. He also acts as the Chair of the Supply Chain Working Group of Efpia where he has lead the work on the implementation of the Falsified Medicines Directive, the work on strengthening supply chains resilience in time of crisis, and most recently he is leading the work on medicines shortage prevention and mitigation at Industry level.

• 

  Daniel Fernandez

  • Data Scientist
  • AstraZeneca, Netherlands

  Daniel Fernández-Llaneza holds an MRes in Drug Development and Discovery (Imperial College London) and an MSc in Health Data Science (UCL). He joined AstraZeneca in 2019 where he got involved in machine learning projects and supported real-world evidence efforts related to clinical trial diversity, vaccine and immune therapies and inflammatory bowel disease (IBD Plexus CCF). He has now started his PhD in prediction and casual machine learning models for drug-induced kidney disease in the Pharmacoinformatics laboratory at Amsterdam UMC.

• 

  Anthony Gill, DrMed

  • Principal Medical Adviser
  • TGA, Australia

  Dr Tony Gill is a public health physician who is a Principal Medical Adviser in the Therapeutic Goods Administration and heads up the Advanced Biological and Therapies Section in the Prescription Medicines Authorisation Branch. In this role he heads up a section involved in the clinical evaluation and market authorisation decision making for gene and cell therapies as well as being involved in developing policy on emerging advanced therapies. In the TGA he has been involved in the regulation of unapproved therapeutic goods, the clinical evaluation of medicines, biologicals and medical devices, and the scheduling of medicines. He was the lead for the introduction of TGA’s medicine shortages section and its medicinal cannabis section.

• 

  Flora Giorgio, MPharm

  • Deputy Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation
  • European Commission, Belgium

  Flora is a pharmacist by training. She is heading the team of Health Technology Assessment at the European Commission in DG Health (SANTE), Unit "Medical devices and health technology assessment". The team is responsible for the Legislative Proposal on HTA, for the Secretariat to the HTA Network, and oversees the activities of the Joint Action EUnetHTA. Flora joined the EC in 2006 in DG CNECT, she worked in the ICT for the Health Unit. Before joining the EC she was the Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.

• 

  Marco Greco, PhD

  • President
  • European Patients' Forum, Belgium

  Dr Marco Greco is the President of the European Patients' Forum (EPF).He currently sits on the Management Board of the European Medicines Agency (EMA) and acts as an observer on the Patients and Consumers Working Party,on behalf of the Board.He works as an attorney at his law firm,focusing on litigation,commerce and consumers' protection legislation.He has been chairman of the European Federation of Crohn's and Ulcerative Colitis Association (EFCCA) and the founder of the EFCCA Youth Group.After an LL.MM in Law, he earned a PhD in Law and Religion, religious freedom and discrimination and canon law at the Universita Cattolica del Sacro Cuore in Milan,where he still collaborates with the Chair of History and Systems of Church-State relations

• 

  Sibel D. Guerler, MSc

  • Head, Innovation, Partnerships & Process Optimization, WorldWide Patient Safety
  • Bristol-Myers Squibb Company, Switzerland

  As a neurobiologist with a penchant for rebellion, Sibel has committed the past 15 years to progressing patient safety. Now, in her role in WorldWide Patient Safety at Bristol Myers Squibb, she focuses on nurturing an innovative culture, upskilling people, identifying the right problems to solve while seeking to break new ground with data, models and digital health solutions.

• 

  Adrian Hernandez, MD, MHS

  • Professor of Medicine; Executive Director
  • Duke Clinical Research Institute , United States

  Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical trials, comparative effectiveness and health policy. Dr. Hernandez leads multiple programs to address COVID-19, including the Healthcare Worker Exposure Response and Outcomes (HERO) registry and pre-exposure prophylaxis trial, and ACTIV-6, a treatment trial for repurposed medications. He has authored over 700 peer-reviewed publications.

• 

  Rhydian Howells

  • Senior Manager
  • KPMG, United Kingdom

  Rhydian Howells is a Senior Manager within the KPMG Regulatory Affairs group with 20 years of experience gained from both industry and regulatory consultancies. He has a particular focus on CMC requirements for the development and regulatory approval of novel ATMP and biological products.

• 

  Tahira Jan, MSc

  • Vigilance Development Collaboration Specialist
  • MHRA, United Kingdom

• 

  Rosanne Janssens, DrSc, MSc

  • Postdoctoral Researcher, Patient Experience Data & Patient Preference Studies
  • KU Leuven, Belgium

  Rosanne Janssens is a post-doctoral researcher at the KU Leuven in Belgium, in the Regulatory Sciences & Pharmaco-Economics research unit. Her research interests and activities are focused on investigating policy and multi-stakeholder challenges and solutions towards optimizing drug development, regulatory, and Health Technology Assessment (HTA) decision-making frameworks spanning across the medicinal product life cycle. During her PhD, she derived methodological and policy-related recommendations regarding the design, conduct and use of patient preference studies for informing drug development, regulatory and HTA decisions. Rosanne holds a Master's degree in Biomedical Sciences (KU Leuven, 2016, summa cum laude).

• 

  Alireza Khadem Broojerdia

  • Team Lead, Regulatory System Strenghtening
  • WHO, Switzerland

  Dr Alireza KHADEM is currently a scientist of the WHO working in the Regulatory Systems Strengthening team. His work is aimed to support WHO Member States to build their national capacity for regulating medical products. During his career in WHO, he has been involved in developing WHO guidelines, as well as benchmarking tools for regulatory systems and organizing and conducting numerous NRA assessments. He has planned and performed many in country trainings during mentioned period.

• 

  Jesper Kjær, MS

  • Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs
  • Novo Nordisk, Denmark

  Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

• 

  Dominique Lagrave, PharmD

  • Senior Vice President of Regulatory Innovation
  • Accumulus Synergy, United States

  Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory Innovation in early 2022 coming from Amgen where he was heading Global Regulatory Operations. As part of his role at Accumulus, Dominique is supporting global Accumulus platform adoption from Health Authorities and Biopharmaceutical organizations. Dominique is also a Board Member of IRISS Forum since 2021 Dominique holds a Pharm D and a master’s in International Regulatory Affairs from the University of Paris.

• 

  Andrew Lennard, PhD, MS

  • Regulatory Affairs CMC
  • Amgen, United Kingdom

  Andrew Lennard has over 25 years’ experience within pharma and biopharma , initially in drug discovery and protein engineering for small molecules and biologics, and for the last 17 years in CMC Regulatory Affairs of which 15 years were at Amgen. His regulatory CMC experience spans Quality parts of the IMPD, Marketing Applications and post-approval changes. Andrew is in a global External Engagement and Advocacy role, working with Trade Associations including EFPIA, BIO and IQ Consortium. He has a strong interest in accelerating CMC through product development, applying prior knowledge and predictive stability modeling. Andrew leads an EFPIA Stability team and is on the ICH EWG for the revision of the stability guidelines Q1 series, Q5C.

• 

  Declan Noone

  • PRAC Patient Representative
  • President of the European Haemophilia Consortium (EHC), Ireland

  Declan Noone is the President of the European Haemophilia Consortium (EHC). He was elected in 2019. Declan has extensive experience as a patient advocate at the national, European and international levels. He worked with the Irish Haemophilia Society (IHS) as Data and Public Policy Specialist for eight years. His primary responsibilities included membership in the national tender board to purchase products for the treatment of haemophilia and other related conditions. He also worked on access to treatments for hepatitis C. During his time with EHC, he also coordinated projects on data collection and novel therapies.

• 

  Cécile Mathilde Ollivier, MS

  • VP Global Affairs
  • Critical Path Institute, Netherlands

  Senior health engineer with 15 years of global drug development experience in children & rare diseases. Cecile joined C-Path as scientific director, prior to C-Path, she was with a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation at EMA for 12 years where Cecile has been leading the EMA extrapolation strategy and was an expert for the ICH E11(R)1 guideline.

• 

  Zack Pemberton-Whiteley, LLM

  • Chief Executive Officer
  • Leukaemia Care, United Kingdom

  Zack Pemberton-Whiteley is Chief Executive Officer at Leukaemia Care, a UK based blood cancer charity. Zack is also Chair of the global Acute Leukemia Advocates Network (ALAN). Zack is a qualified lawyer (BPTC & LLM) whose work primarily focuses on evidence-based advocacy, access and HTA, campaigns, patient involvement, early diagnosis and cancer policy. Zack is active in various committees and advisory boards at a UK, European and global level – including the global CML Advocates Network Community Advisory Board (CAB), the Workgroup of European Cancer patient Advocacy Networks (WECAN) and the European Cancer Organisation Patient Advisory Committee (ECO PAC).

• 

  Douwe Postmus, PhD, MSc

  • Assistant Professor & Seconded National Expert
  • University Medical Center Groningen & EMA, Netherlands

  Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory, reimbursement, and shared decision making problems.

• 

  Karen Quigley

  • Clinical Data Publication Manager
  • European Medicines Agency, Netherlands

  Dr Karen Quigley has a degree in pharmacy from Trinity College Dublin and a postgraduate Masters in Science degree from the same university specialising in the field of controlled drug delivery and rheology. She subsequently obtained her PhD from the Faculty of Medicine, University of London. Karen joined the EMA 15 years ago working in the areas of mutual recognition, scientific advice, veterinary medicines authorisation and availability of medicines. In 2016 she joined the Clinical Data Publication team working on Policy 0070. Prior to joining the Agency, she worked at the Council of Europe in Strasbourg and with the Health Products Regulatory Agency in Dublin.

• 

  Leyla Rahjou-Esfandiary, PharmD

  • Lead CSO, Office of Compliance, CDER
  • FDA, United States

  Leyla Rahjou-Esfandiary, Pharm D, is a Lead Consumer Safety Officer with FDA's CDER, Office of Compliance. She joined the Drug Registration and Listing Staff in 2008 and has been a big part of CDER's implementation of electronic Drug Registration and Listing System (eDRLS), developing CDER's submission tool for registration and listing (CDER Direct), eDRLS Compliance Program and future format of the National Drug Code (NDC).

• 

  Kirsty Reid, PhD, MSc

  • Director Science Policy
  • EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

  Kirsty Reid is the Director for Science Policy at EFPIA – the European Federation of pharmaceutical industry and associations. She is team leader and Science Policy topic lead. She has over 17 years experience in EU public and regulatory affairs covering various EU legislation and policy areas, working specifically on animal experimentation; alternatives to animal testing, and environment, health and safety issues. She obtained her PhD in Biology in South Africa in 2003.

• 

  Elizabeth Scanlan, PhD, MSc

  • ePI Product Owner
  • European Medicines Agency, Netherlands

  Elizabeth Scanlan is Product Owner for electronic product information (ePI) at the European Medicines Agency. Prior to joining EMA in 2016, she worked in communication roles in the biotechnology industry and not-for-profit sector. She holds a PhD in molecular biology from Trinity College Dublin.

• 

  Gabriele Schwarz, MPharm

  • EC ICH E6(R3) Expert Working Group Member
  • Germany

  Gabriele Schwarz, a registered pharmacist, joined the Federal Institute for Drugs and Medical Devices (BfArM) in 2001. She is currently BfArM’s GCP Strategy Expert and represents the EU in the ICH E6(R3) EWG, which is working on a revision of the GCP guideline. She is also contributing to a number of activities of the EMA ACT-EU project. Until the end of 2022, she was Head of BfArM’s GCP Inspectorate. In parallel, she has contributed to the development of a number of European guidelines e.g. for Risk-Based Quality Management, eSource, (e)TMF and Clinical Trials with Decentralised Elements, and also to international guidelines such as the OECD Recommendation on the Governance of Clinical Trials, the ICH E6(R2) and the ICH E19 Guideline.

• 

  Jeffrey Scott, JD

  • Lead Compliance Counsel, Digital, Reporting, and Analytics
  • Pfizer Inc, United States

  Jeffrey Scott has been a member of Pfizer's Compliance organization for over a dozen years. He currently serves as Lead Compliance Counsel for Digital, Reporting, and Analytics, where he works on digital risk issues, manages innovation within the Compliance organization, and leads an Analytics CoE. In previous roles, Jeffrey served as Compliance Lead for Pfizer's Internal Medicine business and Commercial Operations organization. At the outset of his career at Pfizer, Jeffrey worked on internal investigations handling both US and International matters involving False Claims Act, FCPA, research misconduct, and US Anti-Kickback concerns. Prior to joining Pfizer Jeffrey worked at Skadden Arps in NYC and Troutman Pepper in Philadelphia.

• 

  Laura Squire

  • Chief Healthcare Quality & Access Officer
  • MHRA, United Kingdom

  Laura oversees quality and access of products in the UK market, including scientific advice, clinical trials, licensing, marketing authorisations, device registrations, inspections, enforcement, and standard setting. With a PhD and BSc in Biochemistry and Physiology, she started as a post-doctoral research assistant at the Liverpool Institute of Tropical Medicine. Laura has extensive experience of regulatory and organisational transformation and joined Medicines and Healthcare products Regulatory Agency from the Department of Health and Social Care, where she worked on the COVID-19 vaccine deployment programme.

• 

  Lisa Stagi, MSc

  • Patient Safety County Cluster Lead Europe
  • Roche Spa, Italy

  Patient Safety Country Cluster Lead EU Region in Roche and previously Local Safety Responsible for Roche Italy, with the aim to ensure the best journey for patients from safety perspective. Coordinator of PV working group “Ernesto Montagna,” of Società Italiana di Medicina Farmaceutica (SIMeF). Over 20 years of experience in quality, compliance, and pharmacovigilance. Long experience as a speaker in national and international PV congresses.

• 

  Valentina Strammiello, MA

  • Director of Programmes
  • European Patients' Forum, Belgium

  Valentina Strammiello is currently the Director of Programmes at the European Patients Forum where she has been working for the past ten years. She oversees the EPF project portfolio and represents EPF in HTA and health data related activities.Before joining EPF, Valentina worked as freelance OSINT analyst on Security and Energy issues. Self-trained in website management and web 2.0 applications, she is among the founders of ecpa2.0 (European Centre for Public Affairs 2.0), a forum of young professionals in Public Affairs. She holds a BA in International Relations and a Master’s Degree in European Studies.

• 

  Jonathan Sutch, PhD

  • Principal Medicinal Technical Specialist
  • BSI Group, United Kingdom

  Dr Jonathan Sutch is a Principal Medicinal Specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 5 years ago.

• 

  Marlene Thomas

  • Senior International Scientific Director
  • F. Hoffmann-La Roche, Switzerland

• 

  Cynthia L. Verst, PharmD, MS

  • President, R&D Solutions D&DI; 2023 President
  • IQVIA, United States

  Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late phase research for IQVIA, Dr. Verst brings a holistic and comprehensive view of clinical research, and champions the advanced use of real-world data, analytics and technology to advance therapies for patients. Recognized by Fierce Biotech as a top woman in biotech, and as a PharmaVoice 100 leader, she currently sits on the Board of Directors for the Association of Clinical Research Organizations and is the Chair of the DIA Board of Directors.

• 

  Stephanie Von Klot, PhD, MPH, RPh

  • Lead Safety Data Scientist
  • Boehringer Ingelheim International Gmbh, Germany

  Stephanie von Klot, PhD, MPH is Lead Safety Data Scientist in Patient Safety and Pharmacovigilance at Boehringer Ingelheim. She is part of a team engaging in using Real World Data (RWD) for signal assessment of marketed BI products. Stephanie is a pharmacist by training with postgraduate training in public health, epidemiology from LMU Munich and a data science certificate from Harvard University.

• 

  Juergen Wieland

  • Global Drug Development Environmental Sustainability Lead
  • Novartis Pharma AG, Switzerland

  Jürgen Wieland, Novartis’ Global Drug Development Environmental Sustainability Lead. Member of the Env. Sustainability Strategy Leadership Team of Novartis and Novartis’ representative in the SHC Industry Low Carbon Clinical Trial workstream. Jürgen oversees the major topics of Sustainable Product & Process Design in R&D, Sustainable Clinical Trials and environmental Lifecycle Assessments. In his former role, Jürgen was the Finance Head of the Global Clinical Supply function of Novartis.

• 

  Sacha Wissink, PhD

  • Executive Director, Regulatory Affairs Europe
  • MSD Netherlands, Netherlands

  Dr. Wissink joined Regulatory Affairs Europe MSD in January 2014 to lead the company’s oncology efforts, including the registration of the PD-1 inhibitor, Keytruda® as well as its developmental activities. Prior to joining Regulatory Affairs Europe, Dr. Wissink was Director, Global Regulatory Affairs at MSD responsible for Alzheimer’s Disease development. Dr Wissink started her career in Industry in Regulatory Affairs in Organon in 1999, and held different positions of increasing responsibility within Organon, Schering-Plough and MSD. Dr. Wissink received her PhD in Molecular Biology from the University of Utrecht. Prior to joining industry, she held the position of Postdoctoral Fellow at the Hubrecht institute, Utrecht, the Netherlands.

• 

  Alessandra Zago Jorgetto, MBA

  • Regional Patient Safety Head - Emerging Market
  • Boehringer Ingelheim, Germany

• 

  Lingchao Zhang

  • 3rd Investigator of Drug Registration Department
  • NMPA, China

  Lingchao ZHANG, Master Degree. the 3rd Investigator of Drug Registration Department, NMPA. Lingchao has been engaged in drug registration management for a long time. She Participated in the reform of drug review and approval system, developed related NMPA Drug Master File (DMF) and management documents of post-marketing changes of drugs, etc.

• 

  Leonardo Dutra Rosa

  • Head of the International Affairs Office
  • ANVISA, Brazil

  Head of Anvisa's International Affairs Office since March 2020, is a career diplomat who served at diplomatic missions in Lima (Peru) and Montevideo (Uruguay). At the headquarters of the Ministry of Foreign Affairs, he held, among others, the position of deputy head of the MERCOSUR Economic Division, when his responsibilities included coordinating the efforts related to regulatory convergence within MERCOSUR.

• 

  Lorenzo Guizzaro

  • Scientific Officer
  • European Medicines Agency, Netherlands

  Medical Doctor with a PhD in Medical Statistics from the Vanvitelli University and MSc in Drug Development Sciences from KCL. He has been working for 8 years at the European Medicines Agency in both Evaluation and Advice.

• 

  Chitkala Kalidas

  • VP and Head Oncology Regulatory Affairs
  • Bayer, United States

  Chitkala Kalidas, PhD, is the Vice President & Global Head of Oncology Regulatory Affairs and Oncology Sustainability at Bayer. Dr. Kalidas and her team of global regulatory affairs professionals are responsible for developing global regulatory strategies for Oncology drugs and diagnostics across all stages of development and in over 70 countries. Dr. Kalidas is active in the area of regulatory science and innovation to expedite availability of innovative cancer therapies to patients as well as multi-stakeholder collaboration to enhance access to cancer clinical trials. Dr. Kalidas also leads the Oncology Sustainability/Health Equity Initiative at Bayer.

• 

  Georg Neuwirther, MS, MSc

  • IT Director
  • Austrian Medicines & Medical Devices Agency (AGES), Austria

  Georg Neuwirther, Head of IT Austrian Medicines and Medical Devices Agency (AGES MEA), Chair of the eAF Maintenance Group, Co-Chair SPOR Taskforce since December 2021. As Head of IT at AGES MEA, he is responsible for the agency's IT strategy and IT portfolio management, with a focus on solutions that enable innovation in business processes. This includes efficient data and process integration in EU initiatives. As a result, Mr Neuwirther introduced a new IT system called PHAROS, which replaced legacy systems. This flexible solution is the basis for ongoing and further national developments and integration into Europe-wide initiatives such as the implementation of CTIS, UPD, SPOR and others.

• 

  Alex Simpson

  • Access RWE Lead
  • Hoffmann-La Roche, Switzerland

  From London, UK, Alex has been working as a Real World Evidence Strategy Lead in the Global Access department at Roche Switzerland for just over 2 years now. In this role he is in charge of developing strategies that use real world evidence for use in HTA submissions. His background is in epidemiology and he has been working with real-world evidence for over 6 years in a variety of roles that have included consulting and other pharmaceutical companies and is passionate about how real-world evidence can be used to improve and optimise patient care.

• 

  Álmath Spooner, PhD

  • Head of Europe Regulatory Policy & Intelligence (RPI)
  • Abbvie, Ireland

  Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.

• 

  Aimad Torqui

  • Division Head Medicines Evaluation Board
  • Medicines Evaluation Board, Netherlands

  Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

• 

  Rick Vreman

  • Patient Access Manager
  • Roche, Netherlands

  Rick Vreman, Assistant Professor, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Netherlands. The focus of his research is the link between drug regulation and health economics. Rick combines his work at Utrecht University with a part-time appointment at the National Health Care Institute (Zorginstituut Nederland, ZIN) where he advises on improving the methodologies ZIN uses to evaluate technologies for their inclusion in the universal healthcare package in the Netherlands.

• 

  Christa Wirthumer-Hoche, PhD

  • Retired
  • Austria

  Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices Agency. Christa is the elected Chair of the EMA Management Board.

• 

  Michael Zaiac

  • Head of Medical Affairs Oncology Region Europe
  • Novartis, Switzerland

  Michael has 28 years industry experience in Medical Affairs, launching more than 10 new Medicines across a range of therapeutic areas, early commercialization and clinical development. His clinical education is in Surgery (FRCS), Surgical Oncology, Pharmaceutical Medicine (FFPM and specialist registration) and an MBA. He is an elected honorary fellow of Global Medicine Development (GFMD) and elected industry observer of the EMA/EORTC Cancer Medicines Forum. He is a registered as a physician in the UK and Germany.

• 

  Fiona Adshead, DrMed, DrPH, MD, MPH, MSc, FRCP

  • Chair of the Sustainable Healthcare Coalition
  • Sustainable Healthcare Coalition, United Kingdom

  Fiona chairs the Sustainable Healthcare Coalition that inspires partnerships and action on sustainable healthcare and is an independent expert advisor and board member for national and global organisations on wellbeing and sustainability. A high-profile public health leader with a track record of reframing thinking and developing innovative strategy and programmes at the heart of business and government, her previous roles include Deputy Chief Medical Officer and Director General in the UK Government, Director of Chronic Disease and Health Promotion at the World Health Organisation and Bupa’s Chief Wellbeing Officer. Fiona is a visiting Professor at UCL and is a Senior Associate at Cambridge Institute for Sustainability Leadership.

• 

  Monique Al, PhD

  • Special advisor CCMO
  • Central Committee on Research Involving Human Subjects (CCMO), Netherlands

  Monique Al is currently special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is the lead of the CTCG ethics advisory group. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.

• 

  Bandar Al Hammad, MPharm

  • Chief Pharmacist, Regulatory Affairs Department
  • Saudi Food and Drug Authority (SFDA), Saudi Arabia

  Bandar is Chief Pharmacist at the Executive Department of Regulatory Affairs in Saudi FDA since October 2018. Before this, he was in charge of clinical assessment at SFDA, working as Director of Risk-Benefit Assessment Department from Jan 2015 - Oct 2018. He joined Saudi FDA in 2005 as a pharmacist and worked on the establishment of the Pharmacovigilance Center, later working as a Clinical Assessor, at the National Drug Information Center at SFDA 2009-2015. He got his Master’s degree in clinical pharmacy from Curtin University, Western Australia in 2009. His bachelor’s from King Saud university in 2004.

• 

  Rinol Alaj, MBA

  • Director, Clinical Outcomes - Assessments and Innovation
  • Regeneron Pharmaceuticals, United States

  Rinol’s professional focus is centered around integrated Innovation, design thinking, and clinical operation with 15 years of experience in startup and pharma industry. Savvy, results-oriented leader with proven success in transforming and building eCOA organizations from the ground up. In his current role he leads Clinical Outcome Assessment and Patient Innovation team within Regeneron pharmaceutical.

• 

  Jill Baehring

  • Associate Director
  • IQVIA, United States

  Currently, Jill is working on privacy compliance for Research and Development Solutions (R&DS) and Decentralized Clinical Trials globally. Before, Jill was responsible for privacy compliance for the commercial organization of a pharmaceutical company in Germany, where she helped establish privacy processes across Europe. Previously, she worked for a business consultancy specialized in GDPR compliance, where she worked as external Data Protection Officer and co-authored a Data Protection Impact Assessment on Microsoft Office products for the Dutch government. Before specializing in privacy compliance, Jill worked on human rights issues, especially international human rights violations documentation and the right to privacy.

• 

  Marc Bailey

  • Chief Science and Innovation Officer
  • MHRA, United Kingdom

  Marc is a molecular biologist with a PhD in Pathology. Marc has had a varied career starting with academic research on infectious diseases before establishing a team developing physical standards for biotechnology at the National Physical Laboratory and then leading research into Digital Health for a multinational corporation. Marc joined the Agency in 2017 at the South Mimms Laboratory initially as a Head of Division and then as interim Director of NIBSC.

• 

  Nihan Burul Bozkurt, PhD

  • Health Policies Director
  • AIFD, Turkey

  Nihan Burul Bozkurt received her B.Sc. degree in Pharmacy from Hacettepe University. She holds M.Sc. and Ph.D. degrees in Pharmacology from the same University. After getting her Ph.D. she worked in her own project as a guest researcher in Karolinska Institutet, Alzheimers Disease Research Center, Stockholm, Sweden. After having worked in Pharmacology Department at Hacettepe University she joined Novagenix Bio Anaytical R&D Centre. She has conducted several clinical trials as Clinical Director. Since May 2016 she has been working for Ministry of Health, Turkish Medicines and Medical Devices Agency as the Head of Clinical Trials Department.

• 

  Lisbeth Bregnhoj, PhD, MPharm

  • EC ICH E6(R3) Expert Working Group Member
  • Denmark

  Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth has performed numerous GCP and GVP inspections for the last 18+ years on behalf of the Danish Medicines Agency and the European Medicines Agency in various settings such as sponsor sites, QPPV sites, CRO/vendor sites and investigator sites. She is part of the GCP IWG and the e-sub group who has authored the EU Guideline on computerised systems and electronic data in clinical trials. She is also part of the EWG currently drafting ICH E6 R3

• 

  Jasper-Hugo Brouwers

  • Head of corporate affairs, stakeholders engagement and medicines use
  • MEB, Netherlands

  Jasper-Hugo Brouwers has been working at the Medicines Evaluation Board in the Netherlands for over 10 years in several roles. Currently he is the head of corporate and stakeholder affairs, including the medicines use team responsible for electronic product information (ePI). He is also chair of the Dutch Network of Patient Information. Before his time at the MEB Jasper-Hugo worked as a consultant for several medical technology and pharmaceutical companies, and holds degrees in business administration and media & communications.

• 

  Cristiana Campa, PhD

  • Technical R&D Advisor and Senior Fellow
  • GSK Vaccines, Italy

  Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK, with more than 20 years’ experience in Chemistry, Manufacturing and Controls (CMC). In her current role, she is very active in CMC advocacy, with contributions to cross- company discussion on innovative technologies and development strategies, fostering dialogue with Regulatory Agencies. For instance, she is involved in EFPIA and Vaccines Europe/ IFPMA groups on CMC acceleration/ pandemic learnings, and she is the lead of the EFPIA team supporting the planned revision of ICH Q6A/B. Since January 2023, she has been elected as member of PDA Board of Directors.

• 

  Melanie Carr

  • Head of Stakeholders and Communication Division
  • European Medicines Agency, Netherlands

  Melanie Carr is Head of the Stakeholders and Communication Division and a member of the Executive Board at the European Medicines Agency (EMA). She joined EMA in 1996 and has held various roles in pharmacovigilance, the centralised procedure for marketing authorisation, orphan medicines, the SME office and corporate stakeholders department. In her current role she is responsible for stakeholder relations management and communication. She has a degree in Pharmacy from the University of Nottingham in the UK and worked as a regulatory professional in the pharmaceutical industry prior to joining EMA.

• 

  Catherine Chronaki, MSc, PMP

  • Secretary General
  • HL7 Europe Foundation, Belgium

  A computer engineer by training with long experience in Health IT. As Secretary General of HL7 Europe, she is active in Digital Health Policy and Standards. She led Trillium Bridge and Trillium II projects on International Patient Summary standards under the EU-US MoU on eHealth, and the eStandards roadmap for large scale eHealth deployment. Currently, in the H2020 project X-eHealth, she co-lead work on innovative communities of practice for the European EHR exchange format and serve as interoperability lead in the IMI2 Gravitate-Health project and HL7 FHIR Vulcan Accelerator ePI project. Member of the eHealth Stakeholders group of the European Commission (2020-2026) and serves EFMI president of the European Federation for IMIA (2022-24).

• 

  Corneel Coens, MSc

  • Lead Statistician
  • EORTC, Belgium

  Corneel Coens is currently working as a lead statistician at the EORTC Headquarters (Brussels, Belgium). As part of his tasks for the EORTC Quality of Life Department, he is involved in various aspects of Quality of Life in oncological clinical trials ranging from instrument validation to design, analysis and reporting of QoL endpoints. He is one of the lead investigators in the international SISAQOL initiative. He is also the designated study statistician for the EORTC Gynaecological Cancer Group since 2001 and regular contributor for various EORTC educational courses.

• 

  Isabelle Colmagne-Poulard, PharmD, MBA, MSc

  • Head, International Global Regulatory & Scientific Policy
  • Merck, Switzerland

  Isabelle has joined Merck KGaA since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She currently is Head of International Global Regulatory & Scientific policy at Merck and as such actively engaged in international regulatory policy as member of IFPMA since 2014, representative at ICH TrSC, EFPIA and PhRMA ICH WG. Prior to joining Merck, she has worked for several Companies in areas of small and large molecules including in Clinical Development for Servier Laboratories, and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA & RA. Isabelle holds a MSc and a Pharm. D from Lyon (France) coupled with an MBA from Paris (EAP) High Business School.

• 

  Brendan Cuddy, MSc

  • Lead Scientific Officer
  • European Medicines Agency, Netherlands

  Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

• 

  Kevin Cunningham

  • Scientific Officer
  • European Medicines Agency, Netherlands

  Dr. Kevin Cunningham is the PRIME Scientific Coordinator at the European Medicines Agency. He is responsible for coordination of the PRIME scheme, including management of eligibility procedures, as well as support to PRIME-eligible medicinal products. Previously worked as a non-clinical assessor at the Health Products Regulatory Authority (HPRA), Ireland, before joining EMA in 2015 to work on the implementation of the EU Clinical Trials Regulation through the development of the Clinical Trials Information System (CTIS), and most recently as a scientific officer in the EMA Scientific Advice Office.

• 

  Michael Drues, PhD

  • Founder and President
  • Vascular Sciences, United States

  Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies. He received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies. He also works for the FDA, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world. Dr. Drues is an internationally recognized expert, featured keynote speaker and an Adjunct Professor at several universities & medical schools.

• 

  Maria Florez, MA

  • Researcher
  • Pharma As Patients, United States

  Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over a decade. She held strategy roles at Cleveland Clinic Innovations, in the Operational Excellence group of New York-Presbyterian Hospital of Columbia and Cornell Universities, and has served on the boards of early-stage biotech and medtech companies. She publishes widely in peer-reviewed journals. Maria has a BA in economics, a BS in quantitative finance, and a Master’s from The Fletcher School of Law and Diplomacy at Tufts University in International Economics.

• 

  Thierry Gastineau, PharmD

  • Global Head Quality Innovation, Culture & Engagement
  • Sanofi , France

  Thierry Gastineau is Global Quality Head of Innovation, Culture and Engagement at SANOFI vaccines. He has 35 years of experience in the Pharmaceutical Industry, mainly in World Wide Regulatory Affairs and Quality activities. He is a member of multiple associations and working groups, in particular the following ones: • Vaccines Europe: Co-leader of CMC/Quality Core Team and LCM working group • IFPMA: Leader of the Vaccines Head of Quality group and of the working group on Post Approval Changes • Leader of the CMC/GMDP Covid-19 joint Vaccines Europe / IFPMA Task Force By education, he is Pharmacist and he holds a post graduate in molecular biology

• 

  Louise Gill, PhD

  • Vice President Regulatory Policy
  • GSK, United Kingdom

  Louise Gill is VP, Regulatory Policy at GlaxoSmithKline. She leads the regulatory policy and intelligence organisation accountable for defining and driving the global regulatory policy topics. Louise also co-leads the Accumulus Synergy Europe team. Louise has worked in the pharmaceutical industry for over 25 years and held roles of increasing responsibility including: Regulatory leadership to support Brexit; Regulatory Head Europe and Canada accountable for the affiliates in the region and leading Regulatory Therapeutic teams. Louise obtained her doctorate in Biochemistry from Oxford University and has a passion for developing early talent.

• 

  Ali Hansford, PhD, MSc

  • Accumulus Synergy, United States

  Dr Ali Hansford is the Head of Regulatory Strategy Policy at the Association of the British Pharmaceutical Industry (ABPI), a role which covers the policy areas of clinical research, regulation of trials and medicines, licensing and access schemes. Prior to this, Ali was the Head of Science Policy at the ABPI. Before moving to the ABPI in 2017, Ali spent 5 years in the Policy & Knowledge team at Prostate Cancer UK. Ali holds a PhD in the immunology of asthma and allergy from King’s College London and an M.Sci in Pharmacology from the University of Bristol.

• 

  Jane Howard-Jones

  • Senior Director Regulatory Affairs
  • Gilead Sciences, United Kingdom

  Jane Howard-Jones is a Senior Director, Regulatory Affairs at Gilead Sciences International Ltd. She has over 25 years of experience in Global and EU Regulatory Affairs, in anti-infectives including HIV and COVID-19 medicines. Jane has a degree in pharmacy from the University of Sydney.

• 

  Martin Huber, MPH, MPharm

  • Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany

  Dr Martin Huber is the Vice Chair of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Being a pharmacist by training and holding a degree in public health he gathered detailed experience in pharmacovigilance in a hospital setting before entering BfArM in 2010. Since 2013 he is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors'.

• 

  Brad Jordan, PhD

  • Associate Vice President, Regulatory Policy and Strategy
  • Eli Lilly and Company, United States

  Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology and for Biosimilars and Biologics.

• 

  Daisuke Koga, MSc, RPh

  • Director, Office of International Regulatory Affairs
  • Ministry of Health, Labour and Welfare (MHLW), Japan

  Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices, food additives, controlled substances, research grant and global health in the Ministry. From 2011 to 2014, he served as Technical Officer at WHO HQ in Geneva for the WHO Programme for International Drug Monitoring. From April 2020 to July 2023, he served as Division Director of several Divisions in the Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.

• 

  Ye-eun Lee

  • Assistant Director, Department of Novel Product Approval
  • Ministry of Food and Drug Safety(MFDS), Korea, Republic of

  A government official in charge of all product classifications for items including drugs and medical devices. She is also responsible for borderline items having uncertain drug and medical device categories. She has organized the "MFDS Combination Product Conference" in Korea every year. Assists in regulatory development of combination products by publishing protocols for product approval, the review process, and the designation of approval departments for combination products. Before supporting combination products, she managed the post-market safety of pharmaceutical products. She is also affiliated with the Department of Molecular Medicine and Biopharmaceutical Science, Graduate School of Convergence Science, Seoul National University.

• 

  Fabio Lievano, DrMed

  • V.P., Safety Science -Medical Safety Evaluation
  • AbbVie, United States

  Dr. Lievano has extensive experience in medicine, clinical development, risk management, epidemiology, pharmacovigilance at several pharmaceutical companies. Additionally, he worked as a public health expert at WHO European Regional Office and researcher at CDC in Atlanta. He is a physician from Colombia trained in epidemiology at Epidemiology Intelligence Service of the CDC. He manages a large team of scientists (MDs, PhDs, statisticians) in several therapeutic areas mainly Immunology, Oncology and Vaccines. He has authored several papers and abstracts in medical journals and major scientific conferences. In connection with his CDC work he received several awards for distinguished service by the US Secretary of Health and Human Services.

• 

  Claudia Louati, MA, MSc

  • Head of Policy
  • European Patients' Forum, Belgium

  Claudia Louati joined the European Patients Forum (EPF) as Head of Policy in May 2023. She leads EPF’s policy and advocacy work and steers EPF’s engagement with EU and international stakeholders on relevant health policy topics. Before joining EPF, she worked for almost seven years at the Europe Office of the U.S. Food and Drug Administration, based at the U.S. Mission to the EU in Brussels, where she promoted EU-U.S. regulatory collaboration on medical products. She started her career as a communications and public affairs consultant in Brussels. Claudia holds two master’s degrees in European Affairs from SciencesPo Paris and the London School of Economics.

• 

  Laurent Mallet, PhD

  • Head of Biological Standardisation, OMCL Network and HealthCare Department
  • European Directorate for the Quality of Medicines and Healthcare (EDQM), France

  Dr. Laurent MALLET completed his PhD work in Virology and Molecular Biology at Claude Bernard Lyon University in France in 1996. After several positions within Sanofi Pasteur in France and in Canada, he has been the Global Head of Analytical Sciences within Sanofi Pasteur up to November 2019. Since December 2019, he has joined the EDQM, Council of Europe, in Strasbourg, France. He is currently the Biological Standardisation, OMCL Network & HealthCare (DBO) Department Head. He represents EDQM in the WHO Expert Committee on Biological Standardisation (ECBS), in the NC3Rs working group to review animal testing requirements in WHO guidelines, in the COVAX Regulatory Advisory Group, in the IABS Board and in the ICH Q5A Expert Working Group.

• 

  Chris McCurdy

  • Chief Architect for Healthcare & Life Sciences
  • Amazon Web Services, Netherlands

  Chris McCurdy is the Chief Architect of the Healthcare and Life Sciences (HCLS). In this role he leads the Technical Strategy team at Amazon Web Services (AWS) who is chartered with transforming customer signals into AWS’s industry strategies informing new solutions and collaborating with the AWS services teams to build new and innovative offerings. Prior to this role, Chris has been driving HCLS initiatives across for over 16 years. Chris graduated from Oregon State University with a degree in Mathematical Science.

• 

  Heike Moehlig-Zuttermeister, DrSc

  • Head of Business Line IVD
  • TUV SUD, Germany

  Heike is leading the IVD team at TÜV Süd since December 2022. Before joining TÜV Süd Heike spent 8 years at BSI managing a global team of technical experts and 1 year at RQM+ to drive and further strengthens the IVD regulatory team. Heike holds a PhD in Immunology, and she obtains ~20 years’ scientific & regulatory experience in different leadership roles in life technology & IVD industry and at two leading IVDR Notified Bodies, BSI & TÜV Süd. In her position at TÜV Süd she is responsible for the regulatory oversight for all IVDD & IVDR products and respective conformity assessment work. She is driven to establish and maintain a dynamic and practical approach by being compliant to ensure a time sensitive path to reach IVDR certification.

• 

  Deana Mohr

  • CEO & Co-Founder
  • Muvon Therapeutics, Switzerland

  Deana Mohr holds a PhD in Radiopharmaceutical Sciences from the ETH Zurich, with specialization in regenerative medicine. Before this, she studied cell and molecular biology at the University of Constance, Germany. After 5+ years in clinical trial management and consortium coordination, she co-founded a life science company MUVON Therapeutics, where she is currently serving as CEO of a clinical-stage start up aiming at bringing personalized regenerative tissue engineering for skeletal muscle restoration to the next level.

• 

  Vasee Moorthy

  • Senior Advisor, Science Division
  • WHO, Switzerland

  Dr Vasee Moorthy is a Physician with a PhD in malaria immunology, and a background as a Clinical Trials PI and funder. His current main activity at WHO is coordination of development of guidance on best practices for CTs for improving the quality of evidence. In his 14 years at WHO, he has led policy development for the 1st malaria vaccine, set up the horizon scanning process for vaccine R&D, coordinated large CTs consortia for Ebola vaccines and COVID-19 therapeutics (the global solidarity trial), and led the creation of R&D processes at WHO including Target Product Profiles and Coordinated Scientific Advice. He has a medical degree and PhD from the Univ of Oxford and a first class degree in Natural Sciences from the Univ of Cambridge.

• 

  Remco Munnik

  • President
  • IRISS Forum, Spain

  Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

• 

  Irene Norstedt

  • Director - People Directorate, DG Research and Innovation
  • European Commission, Belgium

  Irene Norstedt works at the European Commission where she is the acting Director responsible for the People Directorate within the DG for Research and Innovation. Irene is also Head of the Economic and Social Transitions Unit. Irene has been at the European Commission since 1996, and was instrumental in the creation of the Innovative Medicines Initiative (IMI) in 2008. From 16 December 2014 to 15 September 2015, Irene served as Acting Executive Director of the Innovative Medicines Initiative. Prior to joining the European Commission, she worked for the Swedish life science company Biacore AB and at the Swedish embassy in London. Irene studied biotechnology and polymer science, and holds a Master of Science (MsC) in Chemical Engineering

• 

  Christopher Oduor Okonji

  • African Union Commission, Ethiopia

• 

  Chi Pakarinen, MA

  • Programme Lead
  • Medipace Ltd., United Kingdom

  Chi Pakarinen is a patient engagement enthusiast with strong experience in global-level multi-stakeholder collaborations that aim to bring co-created solutions to advance patient engagement in the healthcare sector. Her work integrates patient engagement into business strategy and processes ensuring that value from patient engagement is not only captured and leveraged from R&D through to market access and standard of care, but also experienced within the patient community engaged. Reach out to Chi to discuss patient engagement strategies and projects.

• 

  Melanie Poulin-Costello, MSc

  • Dir Biostatistics
  • Hoffmann-La Roche Ltd., Canada

  Melanie Poulin-Costello is the Head of Biostatistics at Roche Canada with close to 20 years experience as a biostatistician in drug development. She is passionate about upskilling scientists’ statistical literacy and frequently teaches and discusses statistical concepts. Melanie has degrees from UVictoria and UWaterloo. She spent time living in China. Now, Melanie lives in Georgetown, ON and spends her free time painting and drawing with the local arts community.

• 

  Melissa Ream

  • AHSN
  • in collaboration with UK’s National Health Service, United Kingdom

  Melissa Ream is a health and care strategist in the UK, leveraging user-driven design and artificial intelligence to design systems and support people to live healthier, longer lives. A native Texan living in Canterbury, Melissa has been leading transformational change in England for almost two decades, working across the whole healthcare system, FTSE 100 companies, trade bodies, the Department of Health, NHSX and the Academic Health Science Networks.

• 

  Robert Scheiner, MSc

  • CIO
  • iVigee, United States

  Mr Scheiner started his career lecturing Database Design and Database Management at the University of Technology, Sydney (1997-2000). Since then stayed in ICT technical and leadership roles in private sector and EU regulatory agencies, including EMA where he led the technical development of EudraGMP, EUTCT, EU Clinical Trials, ISO-IDMP and others. He has always focused on implementing complex data pipelines starting from data collection (mostly EU-wide), evaluation, processing, analytics as well as learning from the data. Currently an IT Lead at the European Banking Authority in Paris, and future CIO (as of 1/11/2021) of iVigee.

• 

  Anja Schiel, PhD

  • Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA
  • Norwegian Medicines Agency (NoMA), Norway

  Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and just finished her 3-year term as Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA. She also leads the international HTA team at NoMA.

• 

  Thomas Schindler, PhD

  • Director Global Regulatory Affairs - Regulatory Operations
  • BioNTech SE, Germany

  Thomas M. Schindler, PhD, has studied biology and linguistics, was a member of the TransCelerate Return of Results and Clinical Research Access work streams, is contributing to the Good Lay Summary Practice initiative and the Plain Language Summary Guidance of PFMD. He has some 25 years of experience in both medical affairs and regulatory medical writing, and leads the plain language and lay summary initiatives as head of Innovation Medical Writing at Boehringer Ingelheim Pharma.

• 

  Ines Silva, MPharm

  • IPV Business Process Leader
  • Roche, United Kingdom

  Inês has worked in PV in the pharma industry for the past 10 years. She is currently a Business Process Leader in International Pharmacovigilance at Roche, dedicated to the implementation and enhancing of ICSR Intake & Submission processes.

• 

  Alexandre Templier, PhD, MBA, MSc

  • President and Co-Founder
  • Quinten Health , France

  Alexandre has been working in the field of Life Sciences for more than 27 years. Passionate about information technologies and AI-driven computer-assisted decision-making in complex environments, Alexandre has dedicated his professional career to improving healthcare products and medical practice through Real World Data analytics and AI. Co-founder of Quinten and President of Quinten Health, he is particularly involved in the development of Quinten's activities within the healthcare sector (including projects for industrial companies, healthcare providers, research institutions, and healthcare regulatory agencies). Alexandre was associate professor at Ecole Nationale Supérieure d'Arts & Métiers Paris Tech from 2001 to 2013.

• 

  Katherine (Kit) Valentine

  • Regulatory Senior Program Director
  • F. Hoffmann-La Roche Ltd, United States

  Katherine (Kit) Valentine has over 20 years of experience in the industry, including clinical operations and regulatory affairs. Most recently, Kit led the global filing activities of tocilizumab for the treatment of COVID-19 which utilized data from the RECOVERY trial, the largest randomized trial of potential treatments for COVID-19. Kit is passionate about leveraging opportunities to make drug development more efficient and expediting the availability of innovative medicines to patients.

• 

  Paul van Geffen, PhD, MS

  • Senior Manager, Quality & Regulatory Compliance
  • Deloitte Risk Advisory, Netherlands

  Paul is a Senior Manager Quality and Regulatory Compliance at Deloitte Netherlands, and he is a member of the Life Sciences & Healthcare Regulatory NL Leadership Team. He has 4 years of biomedical research experience and 12+ years of industry experience in delivering regulatory compliance and transformation projects covering a wide range of medical devices, including combination products. Paul is auditor of quality management systems (ISO 13485), and he has in-depth knowledge of the Medical Device Regulations (MDR, IVDR) across the device lifecycle. Paul further supports the life sciences industry and regulators with their regulatory policy and with keeping up with the evolving regulatory landscape.

• 

  Max Wegner, PharmD, RPh

  • Head Regulatory Affairs
  • Bayer AG, Germany

  After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also spent some time in China and the USA. Max Wegner led the Therapeutic Areas organization in Pharmaceuticals Development for four years before re-joining Regulatory Affairs in 2018 as Head of Regulatory Affairs. As a special Pharmacist for Drug Information, he is a member of the examination board of the Pharmacy Association Nordrhein-Westfalen and a college lecturer and speaker for various regulatory topics.

• 

  Baoshu Wen

  • Head of the Office of Quality Management of the CDE, ICH Coordinator
  • National Medical Products Administration (NMPA), China

  Baoshu Wen is Head of the Office of Quality Management at the Center for Drug Evaluation and ICH Coordinator of NMPA in China. He constructs drug review systems, coordinates guideline drafting and revision, and manages daily affairs of the ICH office. Prior to this, as Head of Management and Communication, he managed drug review and coordinated laws and regulations. Mr. Wen has a Bachelor's in clinical medicine, a Master's in Pharmacology, and 15 years of drug review management experience.

• 

  Omar Aimer

  • President of the ISoP North American Chapter
  • ISoP, Canada

  Omar Aimer has more than 19 years of experience in Drug and Device Safety , Quality Assurance and Risk Management in the Pharmaceutical Industry, regulatory authority and Hospital environment in Europe and North America. Omar is an Executive Committee member of the International Society of Pharmacovigilance (ISoP) and Leader of the Medical Device Safety – Special Interest Group (SIG). He has presented in multiple scientific forums and contribute in several per reviewed publications with interest in new technologies, regulation, medical devices, combination products and ATMPs as well as the improvement of pharmacovigilance around the world (LinkedIn : https://www.linkedin.com/in/omar-aimer/).

• 

  Peter Bachmann

  • Deputy-Head, European Union and International Affairs
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany

  Peter Bachmann is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the International Pharmaceutical Regulators Programme (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the Institute of Pharmaceutical Biology, TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.

• 

  Emma Du Four, MBA

  • Regulatory and R&D Policy Professional
  • United Kingdom

  Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.

• 

  Pedro Franco, PharmD, PhD, MS, MSc

  • Senior Director for Global Regulatory & Scientific Policy (GRASP)
  • Merck Serono Limited, United Kingdom

  Pedro holds a degree in Pharmaceutical Science (PharmD), a Master in Organic Chemistry from the University of Lisbon in collaboration with Imperial College in London and a PhD in Orphan drugs and Rare diseases from the University of Sheffield. Currently, he is working as a Director for Global Regulatory & Scientific Policy at Merck, mainly focus on regulatory intelligence, strategy and policy. He is the liaison for the China and Latam region concerning regulatory and policy topics. Previously, he worked at EMA for 12 years in different departments (regulatory affairs, assessment, authorisation of medicines, veterinary, orphan drugs, paediatrics, peer review and quality). Beforehand, he was working at INFARMED as a pharmaceutical assessor.

• 

  Virginie Hivert, PharmD, PhD

  • Therapeutic Development Director
  • Eurordis-Rare Diseases Europe, France

  Virginie Hivert joined EURORDIS in 2014 as Therapeutic Development Director.Virginie is responsible for following the development of orphan drugs as an observer on the Committee for Orphan Medicinal Products at the European Medicines Agency.She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the Therapeutic Action Group (TAG).

• 

  Marianne Lunzer, DrMed

  • Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
  • AGES, Austria

  Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.

• 

  Lorenz Mayr

  • CEO
  • Vector BioPharma AG , Switzerland

  Lorenz is a experienced line manager with Senior (Vice President) & Executive Management (Chief Technology Officer/CTO) experience in global leadership roles at large multinational Pharma & Healthcare organizations (Bayer, Novartis, AstraZeneca, GE Healthcare), academia (ETH Zürich) and Venture Capital (Syncona Investment) with work experience and cultural understanding in Germany, Switzerland, US, UK and Sweden. He has recognized broad scientific expertise in biochemistry, biophysics, molecular & cell biology with widely accepted technical skills in preclinical drug discovery.

• 

  Heraclio Palacios Rodriguez

  • Regulatory Head Policy and Science LATAM
  • Sanofi, Panama

  With more than 27 years of experience in the biopharmaceutical sector in multinational companies such as Bristol Myers Squibb, Merck KGaA, Schering Plough and Sanofi, in various areas such as: Manufacturing, Quality Control and Quality Assurance, Storage and Distribution of drugs, cosmetics, biologics and biotech products, Regulatory Affairs and Clinical Monitoring and sales. Expert on Bio Pharma Latin American Regulation, currently Head of Global Regulatory Science and Policy for LATAM region in SANOFI, and member of IFPMA´s Regulatory Working Group.

• 

  Jan Petracek, MD, MSc

  • CEO
  • Ivigee, Czech Republic

  Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

• 

  Céline Pulcini

  • Full Professor of Infectious Diseases
  • Université de Lorraine, France

  Céline Pulcini (MD, PhD) is Full Professor of Infectious Disease in Nancy, France. She coordinated for four years the French AMR national action plan at the Ministry of Health, 2019-2022. As MoH representative, she was involved in the EU-JAMRAI. Professor Pulcini was Chair of ESGAP, the European Society for Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Antimicrobial stewardship and Associate Editor for the journal Clinical Microbiology and Infection. She is or has recently served also as Expert for the ECDC and the WHO. She has authored or co-authored over 260 international publications (H-index of 39 - Web of Science). She received in 2017 the ESCMID Young Investigator Award.

• 

  Bettina Ryll

  • Member of the First EU Cancer Mission Board
  • MPNE, Vision Zero Cancer, Sweden

  Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered risk/ benefit assessment tools. She lectures and advises on patient-centric drug development, member of ASCO and ISPOR and current chair of the ESMO Patient Advocacy Working Group.

• 

  Claudine Sapède, PharmD

  • Director, Global HTA Policy
  • NOVARTIS INTERNATIONAL, Switzerland

  Claudine Sapède is Director, Global HTA Policy at Novartis. In this role, she focuses on value assessment, HTA and reimbursement decision-making approaches and their impact on patient access to innovative treatments. She engages with internal and external stakeholders involved in shaping HTA, pricing and reimbursement decisions. Claudine is currently a member of the EFPIA market access and HTA working groups, leading the workstream related to the implementation of the EU HTA Reg. Prior to this, she had different roles in the field of pricing and market access, at country and global levels. Her career of over 20 y in the pharma sector spans the full spectrum of evidence generation, value demonstration, MA strategies, pricing, and policy.

• 

  Fakhredin Sayed Tabatabaei, MD, PhD

  • Senior Assessor
  • MEB, Netherlands

  Fakhredin Sayed Tabatabaei is a medical doctor and epidemiologist, working as Senior Assessor Pharmacovigilance at the Dutch national agency (MEB) for more than 17 years. He is also the chairman of the CMDh HaRP Project (Harmonization of Risk Management Plan). Fakhredin was an active member of the European Pioneer Group drafting the electronic product information (ePI) Key Principles that is published in 2020, and he is currently involved in the ePI Pilot Project in the Netherlands. Besides, he is the MEB representative in the Gravitate Health project, and the Network Subject Matter Expert in the Product Management Services (PMS) project.

• 

  Gabriela Zenhaeusern, PhD

  • Deputy Head Stakeholder Engagement
  • Swissmedic, Switzerland

  Gabriela Zenhäusern, a pharmacist with a PhD in biomedical research, joined the Stakeholder Engagement Division at Swissmedic, Switzerland in 2019. In her current position, she is responsible for the coordination of international collaboration, acts as Vice-Chair of the Assembly of the International Council of Harmonisation (ICH) and represents Swissmedic at the International Pharmaceutical Regulators Programme (IPRP) Management Committee and the Access Consortium (Australia-Canada-Singapore-Switzerland-United Kingdom). In addition, she is leading the patient organisation working party at Swissmedic. Gabriela Zenhäusern used to work in the sector authorization at Swissmedic from 2010 to 2015 before joining WHO from 2015 to 2019.

• 

  Maha Al Jaghbeer

  • Pharmacist, Head of Drug Registration Department
  • Jordan Food and Drug Administration, Jordan

• 

  Frank Bretz, PhD

  • Distinguished Quantitative Research Scientist
  • Novartis , Switzerland

  Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has supported the methodological development in various areas of drug development, including dose finding, estimands, multiple testing, and adaptive designs. He was a member of the ICH E9(R1) Expert Working Group on 'Estimands and sensitivity analysis in clinical trials' and currently serves on the ICH E20 Expert Working Group on 'Adaptive clinical trials'.

• 

  Erik Briers

  • Vice Chair
  • EUROPA UOMO, Belgium

  Erik Briers holds a doctorate in Science - Chemistry from the University of Leuven. He founded in 1982 the diagnostic company Eco-Bio diagnostics and served as its CEO. In this function he developed a diagnostic test for the detection of Aspergillus antigens which has been approved by the FDA. He has been a guest lecturer at the University of Leuven, the Executive Director of the ECPC and ad interim executive director of EPPOSI. He was active at the Patient and Consumer working party of EMA and appointed by the EU commission as an alternate patient member of the CAT. He is board member and vice chairman of Europa Uomo and a member of the Guidelines Panel on the treatment of prostate cancer of the European Association of Urology.

• 

  Gwenael Cirefice, PharmD

  • Scientific Officer
  • European Directorate for the Quality of Medicines and Healthcare (EDQM), France

  Gwenaël Ciréfice holds a PharmD degree from the University of Strasbourg, France. He began his career in the vaccine industry in 2007 as a regulatory affairs manager before later joining the Quality of Medicines department of the European Medicines Agency in 2010, with responsibilities in the field of human vaccines and recombinant proteins. He joined the EDQM in 2014 as a Scientific Programme Manager in the European Pharmacopoeia Department, supporting the work of Expert Groups in the area of biologicals, including Group 15 (Vaccines and sera for human use), Group 6 (Biological substances), the Working Parties on Host-cell protein assays, Endotoxin and pyrogen testing, and more recently the Working Party on High Throughput Sequencing.

• 

  Lynne Corner

  • COO and Director
  • VOICE at the UKs National Innovation Centre for Ageing (NICA), United Kingdom

• 

  Viola Savy Dsouza, MSc

  • PhD Scholar
  • Prasanna School of Public Heath, Manipal Academy of Higher Education (MAHE), India

  Miss. Viola Savy Dsouza is a PhD Scholar at Centre for Regulatory Science, Department of Health Policy, Prasanna School of Public Health. She holds a Master of Science degree in Clinical Research from Indian Institute of Public Health, Delhi (IIPH-D) and Post Graduate Diploma in Data Science from Amity Future Academy. Her research interests are in regulatory science, clinical trials and pharmacovigilance. Her dissertation is in predicting Adverse Drug Reaction (ADR) using Artificial Intelligence.

• 

  Falk Ehmann, MD, PhD, MS

  • Head of Innovation and Development Accelerator – ad interim
  • Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands

  Falk Ehmann is Head of the Innovation and Development Accelerator at the European Medicines Agency leading early stakeholder interactions on Innovation and Business Pipeline / Portfolio and Forecasting activities including Horizon Scanning. Falk Ehmann co-chairs the EU-Innovation Network driving EU pharma policy and strategy with current focus on the New Pharmaceutical Legislation. Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and a degree in European and International law.

• 

  Philippe Girard

  • Vice Director, Head of Licensing
  • Swissmedic , Switzerland

• 

  Hugo Hamel, MBA, MSc

  • Associate Director, BRDD
  • Health Canada, Canada

  Mr. Hamel spent his last 23 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator and Division Manager. He is currently Associate Director with BRDD. Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. Mr. Hamel is also a member of the ICH M4Q EWG and ICH Q12 IWG and leads its implementation in Canada. He is pleased to share his experience with the ICH Q12 pilot program in Canada.

• 

  Claire Harrison

  • Chief Digital and Technology Officer
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

• 

  Derek Johnston

  • QA Director, Regulatory Intelligence Office
  • Labcorp Drug Development, United Kingdom

  As Director of Labcorp's Regulatory Intelligence Office, he has the responsibility of advising on regulatory compliance and policy relative to drug development and changes in regulation and/or guidance. He also coordinates cross company compliance initiatives to better position the organization - and its clients - in the changing regulatory landscape. Before joining Labcorp, he studied traditional medicine prior to joining the pharmaceutical industry. Starting at Johnson & Johnson he has worked across functions gaining familiarity with regulations and requirements pertaining to GCP, GCLP, GMP and GPvP. An active ACRO member, ha has been involved across committees, being previous Chair of the EU Scientific & Regulatory committee.

• 

  Dag Jordbru, MPharm

  • Strategic Director, Regulatory Affairs and Better Use of Medicines
  • NOMA, Norway

  Dag R. Jordbru, MRPharmS is Strategic Director for Better use of Medicines at the Norwegian Medicines Agency with responsibility for regulatory activities related to marketing authorisations, pharmacovigilance, product information and distribution of structured product data to support e-prescription in Norway. Working with the Norwegian Federation of Organisations of Disabled People (FFO), the Norwegian Pharmaceutical Product Compendium, the Association of the Pharmaceutical Industry in Norway (LMI) and the Norwegian Pharmacy Association, Dag is currently building a stakeholder coalition to facilitate the transition to digital as the preferred source of product information by healthcare professionals and patients.

• 

  Olga Kholmanskikh Van Criekingen, MD, PhD

  • Clinical assessor
  • Federal Agency for Medicines and Health Products, Belgium

  Olga Kholmanskikh is a clinical assessor at the Federal Agency for Medicines and Health Products (FAMHP), a Belgian National Competent Authority, since 2012. She is an MD by training and holds PhD in Biomedical and Pharmaceutical Sciences.

• 

  Mariammah Krishnasamy

  • Principal Assistant Director, Head of Medical Device Registration Section
  • Medical Device Authority (MDA), Ministry of Health Malaysia, Malaysia

  Ms. Mariammah Kishnasamy brings 27 years’ experience of having served in various positions in the public sector Institute for Medical Research, Malaysia as Research Officer in the Virology department for 9 years, Health Technology Assessment Division as Assistant Director dealing with Secondary Research for 7 years , Ministry of Health Malaysia and currently as Principal Assistant Director, Head of Medical Device Registration Section, in Medical Device Authority, Ministry of Health Malaysia.

• 

  Edel Larkin

  • Director, Disclosures and Transparency
  • Gilead Sciences, Ireland

  Edel Larkin is a Director, Regulatory Affairs at Gilead Sciences Ireland UC. She has over 15 years of experience, starting in Global and EU Regulatory Affairs before moving into Disclosures & Transparency. Edel has a degree in Biotechnology from the National University of Ireland, Galway with a masters in Biotechnological Law and Ethics from the University of Sheffield and graduate diploma of Law from BPP Manchester.

• 

  Lyne Le Palaire, MSc

  • Quality Advocacy Leader
  • Sanofi, France

  Lyne Le Palaire is Quality Advocacy Leader, member of Sanofi Global Quality External Liaison department. She is based in Lyon / France. She graduated in 2003 with Master Sciences degree (MSc) in Strategy, Development & Production in Bio-industries obtained in a French University. She has a 19-years experience in pharmaceutical industry within Quality (both Policy & Manufacturing), Supply Chain & Manufacturing Technology. As Quality Advocacy Leader, She is in charge of developing Sanofi Quality Advocacy position, coordinating Quality Advocacy activities and connecting with external stakeholders. She is also involved in cross-functional activities such as the launch of a worldwide regulatory reliance pilot on Post Approval Changes.

• 

  Stephane Lejeune, MPH, MSc

  • Head International Affairs and Policies
  • European Organisation for Research and Treatment of Cancer (EORTC) , Belgium

  Stéphane Lejeune (male) joined the European organization for Research and Treatment of Cancer in 2002. In 2008, he became EU Programme Officer responsible for coordinating EORTC participation in EU funded projects. As Contract Officer he was in charge of contract negotiation with pharma, research groups and laboratories for EORTC research projects. In 2020, Stéphane was appointed as Head of International Affairs and Policies coordinating the collaboration with European institutions, participation to EU funded projects, legal watch, data protection and privacy and patient involvement. Stéphane received a degree in Social Sciences and a master in Epidemiology and Statistics in Medicine and Public Health.

• 

  Lada Leyens, PhD, MSc

  • Senior Director, EUCAN regulatory head GI
  • Takeda, Switzerland

  Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly in the approval of clinical trials and as a GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure and with the PKWP and PGWP. At Roche, Lada was the Regulatory Lead for digital health programs and the Regulatory Shaping Lead on Clinical Trial Innovation. At Takeda, she leads the therapeutic are of GI and Inflammation for the EUCAN region and is vice-chair of EFPIA-CREG. Lada is passionate about leveraging innovative technologies to make drug development more efficient and bringing innovative drugs faster to patients.

• 

  Paulo Martins

  • Founder & CEO
  • Vitruvian Shield, Switzerland

• 

  Mafora Florah Matlala

  • Pharmacovigilance Manager
  • South African Health Products Regulatory Authority, South Africa

  Mafora is Pharmacovigilance Manager at South African Health Products Regulatory Authority. She has 11 years’ experience in medicine regulation, 3 years as a Medicine Regulatory Officer 8 years within pharmacovigilance. Mafora is a pharmacist with masters in pharmacovigilance and pharmacoepidemiology She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre. She supports the National Immunisation Safety Expert Committee and is a member of African Union Smart Safety Surveillance Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.

• 

  Margareth Ndomondo-Sigonda

  • Head of Health Programs
  • African Union-New Partnership, Africa's Development (NEPAD), South Africa

• 

  Lars Bo Nielsen, MSc

  • Director General
  • Danish Medicines Agency (DKMA), Denmark

• 

  Prisha Patel, MS

  • Senior Manager, Global Regulatory Policy
  • Pfizer Inc, United States

• 

  Martina Penazzato

  • GAP-f, Science Division
  • World Health Organization (WHO), Switzerland

• 

  André Rey, MBA

  • Integrated Disease Solutions Leader
  • F. Hoffmann-La Roche Ltd., Switzerland

  Integrated Disease Solutions Leader for Tumor Agnostic Therapies & Rare Cancers at F. Hoffmann-La Roche Ltd

• 

  Roberto Rigobello

  • Senior Director, Sustainability, International Operations
  • Novo Nordisk, Switzerland

  International business leader with 20 years experience and proven track record of successfully driving sales and innovation growth through sustainability, able to inspire organisations, building high levels of collaboration and enthusiasm bringing people together in pursuit of highly ambitious organisational goals. Finalised successfully an Executive MBA, with a Master degree in Chemical Engineering, he offers first class financial and analytical skills and able to combine creativity with a structured approach.

• 

  Rizwan Waheed Shaik, MPharm

  • Regulatory Affairs Specialist
  • Novo Nordisk, Denmark

  Rizwan is a regulatory specialist at Novo Nordisk, Denmark where he is responsible for regulatory strategies, planning & submissions related to drug-device combination products. He is a pharma postgraduate turned regulatory professional & carries 10 plus year of experience in regulatory affairs. Prior to Novo Nordisk, he had worked for companies like Pfizer, Mylan etc. His experience in regulatory affairs spans across CMC/ device area mainly related to US, EU, & international regulatory submissions & strategies for various types of pharmaceutical drug products including injectables & drug-device combination products. He has been involved in interpreting new and changing regulations worldwide for drug-device combination products.

• 

  Andrei Spinei, MPharm, MSc

  • Scientific Administrator
  • European Medicines Agency, Netherlands

  Andrei Spinei is the Team Lead for manufacturing in the Inspection Office at EMA that deals with GMP inspections, quality defects and product recalls, sampling and testing and international collaborations on GMP and inspections. In his role Andrei works very closely with the GMDP Inspectors Working Group. He holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked for several years in regulatory affairs in the pharmaceutical industry.

• 

  Rebecca Stanbrook, RPh

  • EFPIA ICH E6(R3) Expert Working Group Member
  • Switzerland

  Rebecca Stanbrook has worked in the pharmaceutical industry, as a regulator at the MHRA and at various pharmaceutical companies for over 30 years. Her main areas of interest are clinical trials and pharmacovigilance. She is a pharmacist by profession and holds a Diploma in Research Quality Assurance. Rebecca is thrilled to be a member of the ICH E6(R3) Expert Working Group. Currently Rebecca works as GCP Strategic Lead in Process & Risk Surveillance, in the Strategy, Portfolio and Programme Operations Group of Development in Novartis Pharma AG. She is based in Basel.

• 

  Shannon Thor, PharmD, MS

  • Deputy Director, Office of Global Policy & Strategy, Europe Office
  • FDA, United States

  Lt. Cmdr. Shannon Thor is the Deputy Director of the FDA Europe Office (EO), located in Brussels, Belgium, assuming the role in August 2022. Lt. Cmdr. Thor brings 17 years of experience as a pharmacist and public health leader, with more than nine years in senior policy advisor roles at the FDA. She is responsible for providing leadership and technical expertise on international public health initiatives and U.S.-European Union relations, with a particular focus on maternal health projects such as improving information on the safe use of medicines in pregnancy and during breastfeeding. Her previous FDA experience included policy advisor roles in the Office of Health and Constituent Affairs and in the Office of New Drugs.

• 

  Ana Trullas, PharmD, MPharm

  • Senior scientific specialist
  • European Medicines Agency, Netherlands

  Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further to this, she worked on the implementation of the IVDR and is currently one of the main point of reference for regulatory guidance on companion diagnostics at the Agency. Previously 2003-2014 Ana worked as Product Team Leader in the area of Quality of Medicines at EMA. Prior to joining the Agency, Ana was a pharmaceutical assessor in the Chemical and Pharmaceutical Technology Division at the AEMPs. Ana has over 20 y. of experience within the Pharma. framework.

• 

  Alice Vanneste, MS, MSc

  • PhD Student
  • KU Leuven, Belgium

• 

  Britt Vermeij, PharmD

  • Senior Director Regulatory Policy & Intelligence Europe
  • Teva Pharmaceuticals; IATF Chair, Netherlands

  Britt studied pharmacy at the University of Utrecht. In 2001, she started working for Teva in the Dutch RA Department, which she headed from 2005. In 2009 she got the position of Regional RA Head, managing Western EU local RA departments in 11 countries. In 2012 she changed to the role of EU RA Intelligence and Policy, which changed in April 2018 to Director RA Projects and Policy implementation, being the EU RA project lead for implementation of EU projects like Brexit, ePI and FMD. In 2022 she changed her role to Sr Dir RA Policy and Intelligence, and continue the work on ePI, assessment of new, revised or proposed legislation and TiO2. She joined the Inter-association taskforce on ePI in 2017, became the vice-chair of the IATF in 2022.

• 

  Chantal Walther, MPharm

  • Head Regulatory Assessment Unit 4
  • Swissmedic, Switzerland

  Chantal Walther, Head Regulatory Assessment Unit 4 at Swissmedic (Swiss Agency for Therapeutic Products) holds a Master in Pharmaceutical Science (MSc) from the University of Basel. She worked in pharmacies for four years and joined Swissmedic in 2011 as Regulatory Manager in Unit 2. In 2020 she was promoted to Head Regulatory Assessment Unit 4. She deals with submissions for new- and known active substances in the oncologic field and since 2015 she is involved in international platforms (ORBIS, Access).

• 

  Jenna Claire Willis, PhD

  • Pharmacovigilance Partnering Strategy Leader
  • F. Hoffmann-La Roche, United Kingdom

  Jenna Willis, BSc, PhD is a Pharmacovigilance Partnering Strategy Leader at Roche Products Limited. She has worked in Pharmacovigilance for over 15 years in a range of roles including leading a Risk Management and Epidemiology function and as a safety lead for a number of products throughout the product lifecycle.

• 

  Yue Yang, PhD, MS

  • Research Professor and Doctoral Supervisor, School of Pharmaceutical Sciences
  • Tsinghua University, China

  Yue Yang is the researcher and doctoral supervisor at the School of Pharmacy. She is mainly engaged in research on regulatory science, pharmaceutical regulations and drug policy, member of the Expert Group on the revision of the Drug Administration Law, participated in the formulation of the Vaccine Administration Law, member of the two laws of the State Medical Products Administration publicity group, "Regulations on the supervision and administration of medical devices" publicity group. Her representative works include "Scientific Research on Drug Regulation in the United States", "Introduction to the Drug Marketing Authorization Holder System" and "the 21st Century Cures Act".

• 

  Bettina Ziegele, MA

  • Chair DG SNSA of the EU-Innovation Network at EMA & Liaison Officer,
  • Division Major Policy Issues, Paul-Ehrlich-Institut, Germany

  Bettina Ziegele is Liaison Officer and responsible for stakeholder cooperation and international affairs at the Paul-Ehrlich-Institut (PEI) - the German competent authority for vaccines and biomedicines. After establishing and heading the Innovation Office at the PEI she worked as an expert at the Federal Ministry of Health supporting the "pharma dialogue" to strengthen pharmaceutical development and in the section for biotechnolgical innovations. She then roounded off her knowledge at the Federal Joint Committee (G-BA) on HTA and the requirements of the benefit assessment of medicinal products. Bettina Ziegele is a member of the EU Innovation Network at EMA and Chair of the Drafting Group of the “Simultaneous National Scientifc Advice”.

• 

  Dimitrios Athanasiou, MBA

  • Patient Advocate
  • WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece

  Dimitrios Athanasiou was a PDCO member representing EURORDIS and WDO for the last 6 years. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full-time patient advocate in DMD, he is a board member of World Duchenne Organization (WDO), Chair of Rare Diseases Greece (RDG), and a member of PCWP in EMA.

• 

  Brian Aylward

  • Clinical Assessor & Chair of the PDCO FWG, EMA
  • Health Products Regularity Authority, United Kingdom

• 

  Federico Cimini

  • Qualified Person
  • Swissmedic, Switzerland

• 

  Jacques Demotes, MD, PhD

  • Director General
  • European Clinical Research Infrastructure Network (ECRIN), France

• 

  Jan Frich

  • Executive Director
  • Norwegian Institute of Public Health, Norway

• 

  Georgy Genov, MD

  • Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
  • European Medicines Agency, Netherlands

  Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

• 

  Marc Gitzinger

  • Chief Executive Officer and co-founder
  • BioVersys, Switzerland

  Marc is CEO and co-founder of BioVersys, a clinical stage firm developing next-gen antimicrobial therapies for infectious diseases. With a decade of biotech experience, he launched a uni spin-off in antimicrobial resistance, now a multi-asset company. Assets address unmet needs in TB & Acinetobacter infections. Marc secured $30m non-dilutive funding & $70m equity financing. He established partnerships with Big Pharma and dev orgs. He's BEAM Alliance President and AMR Industry Alliance Board member. He's a thought leader, passionate about saving lives, and co-author on scientific publications & patents.

• 

  Cammilla Horta Gomes, MA, MPharm

  • Latam Regulatory Policy Lead
  • Roche, Brazil

  Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized knowledge and activities in liaising with government agencies, international and regional organizations, industry and other stakeholders in the area of health regulation. Current role in Roche as Regulatory Policy Lead for Latin America.

• 

  Thomas Wejs Møller, MBA, MSc

  • Director Global Regulatory Affairs - Devices
  • Novo Nordisk, Denmark

  Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products and has extensive experience with regulating medical devices. As a former Director of Medical Devices in the DKMA and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety. He has been elected Chair of the Competent Authorities for Medical Devices and has experience in national and international arenas. Thomas holds a master’s degree in political science from the University of Copenhagen. He has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience.

• 

  Alan Morrison, PhD

  • Vice President Regulatory Affairs Intl
  • MSD, United Kingdom

  Alan leads the MSD international regulatory organization across EMEA, Canada, Latin America and Asia Pacific. He is a part of the Global Regulatory Affairs & Clinical Safety leadership team, also working with international cross-divisional leaders from across the business on the overall strategy and direction of the ex-US business & organization. Previously, Alan also held leadership positions in global regulatory affairs at several multinational companies. He is active in professional qualification and membership societies, including PhRMA and EFPIA. Holds a B.Sc. in Biology & Physiology from the University of Stirling. Alan acts on several trade association committees related to biotechnology/biopharmaceuticals.

• 

  Lucinda Orsini, MPH

  • Vice President - Value and Outcomes Research
  • COMPASS Pathways, United States

  Lucinda Orsini is currently Associate Chief Science Officer at ISPOR. The science office at ISPOR develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Lucinda has spent most of her ~20-year career in health economics and outcomes research. Starting at Truven Health Analytics, Lucinda managed projects using health care claims data for external clients. She has worked in the pharmaceutical industry at Bristol-Myers Squibb and subsidiaries in Global HEOR focused on oncology and immunotherapy leading and publishing on patient reported outcomes, health economic modeling and real world evidence studies. Lucinda has also led HEOR efforts at PAREXEL a full-service contract research group.

• 

  Mariam Al Jalahma

  • CEO
  • National Health Regulatory Authority (NHRA), Bahrain

  Dr Mariam Al-Jalahma is a consultant family physician. She is recently appointed by His majesty the King, as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. She is a member of the Executive Board of The Health Ministers' Council for GCC States since 2007. Dr. Al-Jalahma worked as an advisor for the world health organization in the fields of Adolescents and NCDs, and is a member of the Commission Committee in WHO Geneva Headquarters. She was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015.

• 

  Christelle Anquez-Traxler, PharmD

  • Regulatory and Scientific Affairs Manager
  • AESGP, Belgium

  Dr. Anquez-Traxler graduated as a pharmacist and has a Master’s Degree in European Regulatory Affairs as well as in Economics of Health Products. She manages regulatory and scientific affairs for the Association of the European Self-Medication Industry since 2004. She was previously working for the US FDA at the Office of International Programs.

• 

  Elena Bonfiglioli

  • Global Business Leader, GM Healthcare, Pharma and Life Sciences
  • Microsoft, Belgium

  As lead for Health and Life Sciences, Elena is responsible to drive strategy, advance the digital transformation agenda with health and pharma customers, and represent Microsoft’s industry position, working together with a community of over 250+ professionals across the EMEA region. Over the last ten years, Elena has been a proactive contributor in the areas of healthcare policy, health-tech innovation, and multi-stakeholder partnerships. In July 2017, Elena was elected to the HIMSS Europe Governing Council. Elena spearheaded key initiatives on Health 4.0 and health digital transformation.

• 

  Tony Clark

  • Technical Director
  • Cambridge Spark, United Kingdom

  Tony leads the client relationships team and supports and advises our strategic client partners on how they can achieve their business goals by developing their Analytics, Data Science & AI capabilities. Background: Commercial & operational leader across FMCG and Tech sectors Degree in Biotechnology & Strategic Management from University of Edinburgh Published co-author in peer-reviewed journal PLoS Biology Honorary Fellow at Anglia Ruskin University - Cambridge

• 

  Lucia D'Apote, DrSc, RAC

  • Executive Director Global Regulatory and R&D Policy (ELMAC and JAPAC)
  • Amgen, Switzerland

  Lucia joined Amgen as Director European Lead in Global Regulatory and R&D Policy in September 2018, after 12-year tenure at the European Medicines Agency. Lucia current roles focusses on advancing policy objectives related to the European regulatory environment. She represents Amgen in a number of EU trades associations working groups. In her most recent position at EMA, Lucia was part of the EMA SciRS Office; her work was instrumental to deliver the EMA Regulatory Science Strategy 2025. She covered several regulatory affairs management roles in pharma industry in the previous 9 years. Lucia is a biologist by training, holds a PhD in molecular biology from the University of Bologna and a Master in Regulatory Affairs.

• 

  Sophie Dagens, LPN

  • Regulatory Policy Officer
  • Medicines For Europe, Belgium

  Sophie Dagens is a Regulatory Policy officer at Medicines for Europe, representing the generic, biosimilar and value-added pharmaceutical industry. She works on digitalisation initiatives, anti-counterfeiting, and industrial policy.

• 

  Martin De Kort, PhD, MS

  • Senio Scientific Program Manager
  • EATRIS ERIC, Netherlands

  Experienced R&D (project) manager with over 10 years of experience in the (bio)pharmaceutical industry and academic life sciences sector. A real ‘project champion’ with an interest to develop challenging concepts in a comprehensive manner. Driven by goal-oriented collaboration in multidisciplinary teams. Experienced in executing projects led on the basis of ‘leadership by example’, resulted in five novel preclinical candidate drugs in the areas of thrombosis, diabetes and endocrinology (two of which later progressed to Ph I/II). Presented work as biotech/drug discovery expert on international scientific conferences.

• 

  Britt Dhaenens, DrMed, DrSc

  • MD, PHD Student
  • Erasmus University, Netherlands

  Drs. Britt Dhaenens received her medical degree in August of 2019. In December of that same year, she started with her PhD project on Neurofibromatosis at the Sophia’s Children’s Hospital in the Netherlands. The PhD revolves around the EU-PEARL project, which aims to create a sustainable Research Platform for Neurofibromatosis, enabling easier, faster and more patient-friendly drug trials for this condition. In addition, she focusses on the development and validation of patient-reported outcome measures for Neurofibromatosis Type 1.

• 

  Mark Duman

  • Patient Advocate
  • Diabetes UK, United Kingdom

  Mark Duman MRPharmS brings over 30 years of clinician, management consultant and patient perspectives to the healthcare, life sciences and digital health sectors. Working in the NHS, The King’s Fund, the BBC, and as a Founder of the Patient Information Forum, Mark endeavours to make healthcare more person-centric. As the Chief Patient Officer for MD Healthcare, he works with public and private organisations to harness digital health, develop markets and improve patient engagement.

• 

  François Houyez

  • Treatment Information and Access Director, Health Policy Advisor
  • European Organisation for Rare Diseases (EURORDIS), France

  François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

• 

  Nigel Hughes, MSc

  • Scientific Director, Observational Health Data Analytics/Epidemiology
  • Janssen Research and Development, Belgium

  Nigel Hughes has a thirty-five year career spanning the NHS in the UK (16 years), NGOs and patient organisations (10 years) and within the pharmaceutical industry (17 years). He has worked clinically in HIV and viral hepatitis, liver disease, and in sales & marketing, medical affairs, market access and health economics, R&D, precision medicine, advanced diagnostics, health IT and Real World Data/Real World Medicine. His experience covers clinical, education, as an advisor, consulting, communications and lobbying over the years. Currently the Project Lead for the IMI2 European Health Data & Evidence Network, he was Platform Co-Lead for the IMI1 EMIF, as well as consulting on numerous projects and programmes in the domain of RWD/RWE

• 

  Melissa Hunt, MSc

  • Director
  • Health Canada, Canada

  Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.

• 

  Neil Mackillop, DrMed, MD, MBA, FFPM

  • Senior Director
  • AstraZeneca, United Kingdom

  Neil Mackillop has worked all phases of Clinical Development across many different disease areas. He also has a long-standing interest in Environmental Protection with a focus in recent years in quantifying and reducing the carbon emissions from clinical trials. The Sustainable Healthcare Coalition of pharma, academics and healthcare systems is co-ordinating a workstream of the Sustainable Markets Initiative that is producing guidance and tools that will deliver in 2024 and enable all pharma and academics to run low-carbon clinical trials. Get ready now!

• 

  Antoine Manson, PharmD, MPharm

  • Regulatory Policy and Innovation Specialist
  • Bayer AG, France

• 

  Jerome Michaud

  • COO
  • PhenomX Health , Switzerland

  Jérôme benefits from a successful entrepreneurial experience (B2B translation agency that he co-founded, developed during five fiscal years, and sold) and 10+ years of experience with P&G (corporate and open innovation, portfolio management, business operations) where, among other things, we successfully managed the acquisition of Merck Consumer Health and developed the P&G Startup Program in Switzerland. EPFL Engineer (Materials Science) by background, Jérôme is also a certified PMPÒ and SLIIÒ trainer.

• 

  Greet Musch, PhD

  • strategic adviser
  • FAMHP, Belgium

  Mrs Greet Musch obtained a PhD in Pharmaceutical & Biomedical Sciences @ Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs . She moved to the Federal Public Health services as senior quality assessor. Since Aug 2004 she was in charge of the R&D department. On Feb 2009 she has been designed as Director-general for the DG Pre-authorisation in the FAMHP.

• 

  Mark Pellett, PhD, MSc, RPh

  • Senior Director and Group Manager
  • AstraZeneca, United Kingdom

  Mark is a registered UK Pharmacist and was awarded his PhD in Pharmaceutical Sciences at University of Wales College of Cardiff and then completed his post-doctoral studies at both Cardiff and the University of Queensland, Australia. He started his industrial career in pharmaceutical product development for Wyeth and then moved into CMC Regulatory Affairs at Pfizer, GSK, Shire, Biogen and AstraZeneca, working across small molecules, biologicals and vaccines supporting pre-Phase 1 CMC strategies through to post-approval life cycle management. Mark is currently Sr Director and Group Manager at AstraZeneca, and was a regional lead for Vaxzevria, AstraZeneca’s COVID-19 vaccine.

• 

  Peter Rijnbeek, PhD

  • Professor Medical Informatics
  • Erasmus MC, Netherlands

  Peter Rijnbeek is Professor of Medical Informatics and Chair of the Department of Medical Informatics of the Erasmus MC. He leads the research line Health Data Science. He obtained his MSc in Electrical Engineering and his PhD thesis was on the development of a computer program to automatically interpret pediatric electrocardiograms. The HDS team has a leading role in the Observational Health Data Sciences and Informatics initiative that is enabling the generation of reliable evidence from observational data at an unprecedented scale. He is the coordinator of the European Health Data and Evidence Network IMI project and the executive director of the DARWIN EU Coordination Center for EMA.

• 

  Christina Schlecker, DrMed

  • Senior patient safety physician
  • Boehringer Ingelheim International Gmbh, Germany

• 

  Leire Solis

  • Health policy and advocacy senior manager
  • International Patient Organisation For Primary Immunodeficiencies (IPOPI), Belgium

  Leire Solís is Senior Manager for Health Policy and Advocacy at the International Patient Organisation for Primary Immunodeficiencies (IPOPI) since 2014. In this capacity, she is involved in advocacy programmes at international, European and national level to ensure that the patient’s voice is heard. Leire is IPOPI’s alternate member to European Medicines Agency Patient and Consumer Working Party (PCWP) and a member at the Rare Disease International Advocacy Committee. Leire holds a bachelor’s degree in Sociology, a Master’s in International Affairs and is a EUPATI Fellow on medicines research and development.

• 

  Camille Vleminckx

  • Scientific Administrator
  • European Medicines Agency, Netherlands

  Camille Vleminckx is a pharmacist with a master’s degree in Medicines Regulation in the European Union. She is currently working in the Oncology and Haematology Office in the Human Medicines Division at the European Medicines Agency. She has been involved in providing scientific and regulatory input to the evaluation of oncology medicines since 2012. Since 2021 she has been working on the implementation of the In Vitro Diagnostic Devices Regulation (IVDR) 2017/746/EC.

• 

  Gülbengü Yüksel

  • Head of Quality
  • Tigen Pharma SA, Switzerland

  Design, implement and maintain GCP and GMP programs and processes Building and ramping up organisations and lead their transformation and cultural change journey Management of new site projects and build up organisations and systems Building and Management of Quality Assurance and Quality Control systems and departments Have a professional understanding of GMP&GCP&GLP and their aspects in pharmaceutical industry Validation expertise on computerised system validation, process validation, cleaning validation and equipment&infrastructure qualifications

• 

  Ditte Zerlang Andersen, PhD, MSc

  • Senior EU Project Lead
  • Danish Medicines Agency (DKMA), Denmark

  Ditte Zerlang Andersen joined the clinical trial department at the Danish Medicines Agency (DKMA) in 2015. Starting as a clinical trial assessor, she now leads strategic European alignments in our regulatory clinical trial landscape as a Senior EU project lead. Ditte led the recent task force delivering the recommendation paper on decentralized elements in clinical trials from the European medicines regulatory network (EMRN) in Dec 2022. Currently, Ditte lead the ‘COMBINE’ project on the CTR, IVDR, MDR interface and coordinates the ACT EU priority area on methodologies. Prior joining DKMA, Ditte worked 5 years in the pharmaceutical industry and have a PhD in neuroscience.

• 

  Larisa Aragon Castro

  • Executive Board Member
  • EUPATI Switzerland, Switzerland

• 

  Valentina Barbuto

  • Policy Officer
  • European Commission, Belgium

• 

  Julian Isla, MS

  • Director
  • Foundation 29, Spain

  Julian is the father of Sergio, a young boy fourteen years old who has Dravet Syndrome Founder the European Dravet Syndrome Federation and Dravet Syndrome Foundation in Spain Dravet Syndrome is an epileptic encephalopathy having long lasting seizures refractory to treatment as severe developmental delay as main symptoms. Julian is software engineer by training, and he works for Microsoft as full time employee on Artificial Intelligence projects. Julian is also founder of Foundation 29, a NPO doing research on AI to improve life of patients: Julian is also member of the Orphan Drug Committee at European Medicines Agency and member of different NPO boards.

• 

  Martin Landray, PhD, FRCP

  • Chief Executive
  • Protas, United Kingdom

  Martin is Co-chief investigator of the RECOVERY trial, the world’s largest randomised trial of potential treatments for COVID-19. He is Interim Director of Oxford's Big Data Institute and leads the clinical trials program for Health Data Research UK.His research focuses on the use of digital technology and quality-by-design principles for large randomized trials, particularly of treatments for cardiovascular and kidney disease.He continues to practise clinical medicine as an Honorary Consultant Physician at Oxford University Hospitals NHS Foundation Trust.

• 

  Kristina Larsson, MS

  • Head of Orphan Medicines, Division for Human Medicines Evidence Generation
  • European Medicines Agency, Netherlands

  Kristina Larsson joined the orphan team of the EMA as the Head of Office in July 2014. Before that she spent 8 years as a scientific officer in the scientific advice team of the EMA in charge of the Scientific Advice Working Party secretariat. Before joining the agency she worked three years in clinical research for AstraZeneca in Mölndal, Sweden. Kristina has a master of Medicine in Pharmaceutical Bioscience from the University of Gothenburg.

• 

  Martin Leu

  • Head of Unit Quality Assessment of Biologics
  • Swissmedic, Switzerland

• 

  Larry Liberty

  • Temple University School of Pharmacy , United States

• 

  Dimitra Lingri

  • Senior Legal Expert for EOPYY/ Managing Director of EHFCN
  • European Healthcare Fraud & Corruption Network , Belgium

• 

  Katja Pecjak, MPharm

  • Director BD, Sales and Marketing
  • Billev Pharma East Ltd., Slovenia

  Katja has a Master’s in Pharmacy and has been in Pharmaceutical Industry for 20 years. Her journey in Billev Pharma East Ltd. started in September 2008, as a Director of Regulatory Affairs and EU QPPV. Presently, she is responsible for the business development within the company and empowering the team with a profound understanding of intricate pharmaceutical business processes. Her expertise has been sought when she was called upon to assume the role of Subject Matter Expert in the EMA ePI Pilot Project, representing the Pharmaceutical Industry perspective since July 2022. She is a member of Medicines for Europe working groups (RSAC, Telematics), TOPRA and an ePI Topic Group Lead in IRISS Forum.

• 

  Nathalie Seigneuret, PharmD

  • Senior Scientific Project Manager
  • Innovative Medicines Initiative (IMI), Belgium

  Nathalie is a senior scientific project manager at IHI within the Scientific Operations team, with responsibilities ranging from the coordination of activities within the team, the management of large and complex research projects and support to public-private consortia, to engagement with stakeholders with particular focus on regulatory bodies.Nathalie joined in 2012 the Innovative Medicines Initiative (now IHI), after having worked at the European Medicines Agency (EMA) over 15 years as a scientific administrator with various responsibilities related to the development and approval of medicinal products. She is a state-certified Doctor in Pharmacy with degree in international drug development and registration.

• 

  Tiago Villanueva

  • Vice-President
  • UEMO, Portugal

  Tiago Villanueva is a family physician working in the Portuguese National Health Service and President, European Union of General Practitioners / Family Physicians (UEMO). He represents UEMO in the Healthcare Professionals Working Party of the European Medicines Agency.

• 

  Lutz Wevelsiep

  • Managing Director
  • UNION Therapeutics A/S, Denmark

  More than 25 years of experience in international regulatory affairs across Europe and the US within multinational and start-up companies. His experience includes EU decentralized and centralized procedures, product development from Phase I through marketing as well as particular expertise in anti-infectives. Lutz has prepared and managed interactions with all health authorities including the FDA, EMA, and EU national agencies. Prior to joining UNION, Lutz spent 16 years as Head of Global Regulatory Affairs at Basilea Pharmaceutica. Lutz holds a Ph.D. and Postdoc in Chemistry from the Max-Planck Institute in Germany.

• 

  Raymond Anderson

  • Retired Community Pharmacist, former PRAC Member
  • Formerly Andersons Pharmacy, Belgium

  Raymond Anderson, BSc(Hons) FPSNI FCPA FFRPS. Over 40 years experience working as a community pharmacist in Portadown, Northern Ireland. Raymnod has held a wide range of professional and non-executive positions including; President of the Pharmaceutical Society of Northern Ireland and President of the Commonwealth Pharmacists Association. He currently sits on the the EMA’s Pharmacovigilance Risk Assessment Committee, appointed as a Healthcare Professional representative by the European Commission and is the N.Ireland delegate to PGEU (Pharmaceutical Group of the European Union). He is a Fellow of the Pharmaceutical Society of N. Ireland, the Commonwealth Pharmacists Asscoiation and the Faculty of the Royal Pharmaceutical Society.

• 

  Franck Deveaux

  • HUDERF Hopital Universitaire des Enfants Reine Fabiola, Belgium

• 

  Engy El-Hosary

  • Head of Central Administration of Biological and Innovative Products and Clinic
  • Egyptian Drug Authority (EDA), Egypt

  A pharmacist with regulatory experience over 19 years at national and international level. A WHO Consultant supporting WHO Regulatory Systems Strengthening Team in NRA benchmarking and building regulatory capacities of NRAs, A Member in WHO Technical Advisory Group TAG on Local Production and Technology Transfer of Health Products, which act as an advisory body to the WHO Local Production and Assistance Unit. A United Nations Experts for GMP Inspections as well as a Former Rotational Prequalification Inspector in WHO PQ Inspection Team.

• 

  Obaidullah Malik

  • Director
  • Drug Regulatory Authority of Pakistan , Pakistan

  Pharmacist with Ph D degree in Pharmaceutical Sciences and Master of Public Health with about 23 years professional experience. Associated with Drug Regulatory Authority of Pakistan since 2001. DRAP is responsible for to regulate therapeutic goods (pharmaceutical, Biological, Medical Devices, Health & OTC Products and Alternative Medicines). Presently working as Director (Pharmacy Services Division) responsible to supervise clinical trial, Pharmacovigilance, AMC and other Pharmacy Services related matters.

• 

  Nermina Nakas, MD, MPH

  • Vice President, Medical & Scientific Strategy
  • Syneos Health, United States

  Nermina Nakas, MD, MPH, Executive Medical Director at Syneos Health, has over 25 years of experience in the CRO, academic, and World Health Organization (WHO) research. Dr. Nakas held multiple senior level and leadership medical and scientific positions overseeing global clinical trials phase I-IV for large pharma and small biotech clients. Her therapeutic expertise includes rare diseases, pediatric and adult epilepsy, seizures, Epileptic Encephalopathies, Dravet Syndrome, Lennox Gastaut Syndrome (LGS), Doose syndrome, Attention Deficit Hyperactivity Disorder (ADHD), Parkinson's disease, Duchenne Muscular Dystrophy, Ataxia Telangiectasia, Chronic Rhinosinusitis with Nasal Polyps, and Rheumatoid Arthritis, just to name a few indications.

• 

  Deka Nipom, MD

  • Global Safety Medical Director, Immuno-Oncology
  • Amgen, United States

  Nipom Deka is a Physician with 7 years of valuable experience in various Departments of Medicine, Surgery, Accident & Emergency and Orthopedics in India & abroad. In 2007, he started his career in Pharmaceutical Industry as a Clinical Investigator for a Phase II trial. Eventually, he moved into Pharmacovigilance joining as a Pharmacovigilance Physician. He was also involved in setting up of Pharmacovigilance units in various country offices in Asia, Africa & Middle East for multiple pharmaceutical companies. Having worked in Pharmacovigilance for more than 10 years, he has gained experience in areas including signal detection, benefit-risk assessment, risk management plan and various process improvement initiatives.

• 

  Francisco Nogueira, MBA

  • Chief Executive Officer
  • Accumulus Synergy, United States

  Frank (Francisco) A. Nogueira is the Chief Executive Officer for Accumulus Synergy. With over 30 years of industry experience, Frank is dedicated to transforming how drug innovators and health regulators interact to bring safe and effective medicines to patients faster and more efficiently. Frank joined Accumulus Synergy in 2020 from Genentech, a Roche company, where he spent over 20 years applying his regulatory strategy, asset development and commercialization expertise to deliver enterprise value and bring medicines to patients. Frank is recognized as an innovative leader with a passion for disrupting the status quo and is known for leveraging his extensive leadership experience to make a positive impact for patients all around the world

• 

  Representative Invited

  • Head of Unit 'Digital Health' unit - DG SANTE
  • European Commission

• 

  Charlotte Thibault

  • Policy Coordinator
  • European Pharmaceutical Students' Association (EPSA), Belgium

  Charlotte is a 5th-year pharmacy student originally from the University of Grenoble Alpes, France. She is currently in Brussels to complete her master's. In her engagement as Policy Coordinator for the European Pharmaceutical Students Association (EPSA), she is in charge of all policy matters and advocacy in order to represent truthfully all European Pharmaceutical Students across Europe. Passionate about advocacy and health policies she intends to specialize in this field in the future. It is her great honour and pleasure to represent EPSA during DIA Europe this year!

• 

  Slawa Troubniakov

  • Director, Strategy Implementation
  • Merck Group, Germany

  Slawa is leader of strategic programs at the R&D department of Merck Healthcare. In this capacity, he defined and implemented the sustainability strategy in R&D, including project oversight, KPI definition, internal and external communication and industry collaborations, such as Sustainable Markets Initiative (SMI), where the teams aims to establish a framework to measure and reduce CO2 in clinical trials. Slawa holds a degree in business administration and work & organizational psychology.

• 

  Pascal Wettstein

  • Regulatory Expert
  • VolV, Switzerland

• 

  Marie Valentin, PharmD

  • Team Lead, Facilitated Product Introduction
  • WHO, Switzerland

  At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international level to facilitate and accelerate the introduction of priority medical products in countries. Before joining the WHO in May 2019, Marie worked for 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

• 

  Rosa Castro

  • Senior Policy Manager for Healthcare Delivery and Networks’ Coordinator
  • European Public Health Alliance, Belgium

  Dr Rosa Castro is Senior Policy Manager for Healthcare Delivery and Networks’ Coordinator at the European Public Health Alliance (EPHA). Among other activities, she coordinates the European Alliance for Responsible R&D and Affordable Medicines, the EU4Health Civil Society Alliance, and represents EPHA at the Patients’ and Consumers Working Party (PCWP) of EMA.She has a PhD in European Law and Economics, and an MA in Bioethics and Science Policy.Dr Castro was a postdoctoral Fellow at the European Uni Inst and a lecturer on intellectual property and international health law. Before joining EPHA, she worked at the Fed. of European Academies of Medicine and at a public policy consultancy, where she managed EU-funded projects on public health.

• 

  Wim Goettsch

  • Associate Professor
  • Utrecht University, Netherlands

• 

  Raun Kupiec, MS

  • Head of Global Blood Health Initiatives
  • CSL Vifor, Switzerland

  Mr. Kupiec is a recognised authority on regulatory operations, and has served on multiple industry committees and editorial boards – including TOPRA, RAPS, EuropaBio and joint industry/regulator projects at the EMA. He is currently a member of the EFPIA Telematics WG, and representative to ICH M2.

• 

  Yann Le Cam, MBA

  • Chief Executive Officer
  • Eurordis-Rare Diseases Europe, France

  Yann Le Cam was one of the founders of EURORDIS-Rare Diseases Europe in 1997. He is the organisation’s Chief Executive Officer since 2000. Yann initiated Rare Diseases International (RDI) in 2009. He is an elected member of the RDI Council and Chair of the RDI Advocacy Committee. He is a founding member of the NGO Committee for Rare Diseases (United Nations, New York) in 2014 and its Vice-Chair. Yann is a Co-Chair of the Global Commission to End the Diagnostic Odyssey of Children with Rare Diseases since its launch in 2018. Yann is a member of the World Economic Forum’s Health Stewards Board from 2020 and of its Global Precision Medicine Council since 2019. More on recent past positions https://www.eurordis.org/staff

• 

  Jessica Liu, MD

  • VP, Head of Merges and Acquisition Management Department
  • Tigermed Consulting Co., Ltd, China

  Dr. Liu is VP and Head of M&A Management at Tigermed Co. Ltd, a global CRO focused on clinical development. Her recent 1.5-year role involves finding and acquiring well-matching partners for Tigermed's global service platform. With 29 years of experience in clinical research and development for global pharmaceutical companies and CROs, she has managed Phase I-IV studies across multiple therapeutic areas. Jessica is trained in Clinical Medicine and has a post-graduate diploma in Pharmaceutical Medicine from the University of Basel. She has also dedicated much of her personal time to DIA China development.

• 

  David Mukanga, PhD, MPH

  • Deputy Director, Africa Regulatory Systems
  • Bill & Melinda Gates Foundation, United States

  Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports the development of harmonized, transparent, and predictable regulatory systems covering the lifecycle of medical products in Africa across the national, regional, and continental levels of the ecosystem. His work also involves support for regulatory emergency preparedness. In this role he works side by side with partners on the African continent to facilitate development of new medical products, as well as patient access to quality essential medicines.

• 

  Patricia Oliveira Pereira Tagliari, LLM, MPH

  • Associate Director of the Second Directorate
  • ANVISA, Brazil

  Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree in International Affairs from the University of Brasilia (2004). She is currently a government employee, specialist in health regulation and surveillance, at the Brazilian Health Regulatory Agency - Anvisa. From April 2020 to the present date, Ms. Tagliari has served as Associate Director at Anvisa. Prior to that, she served as Advisor at Anvisa’s Office of Inspection and Health Surveillance and as the Head of Anvisa's International Affairs Office.

• 

  Mariana Santos, PharmD, LLM, MPharm, MSc

  • International Affairs Officer, PharmD, MSc
  • European Medicines Agency, Netherlands

• 

  Bruno Sepodes, PharmD, PhD, MPH, MSc

  • Vice-Chair CHMP (EMA); Senior Expert INFARMED
  • INFARMED, Portugal

  Bruno Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon (Portugal). Besides being Senior non-clinical expert for INFARMED (Portuguese National Authority for Medicines and Health Products), he became a member of the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) in 2008, and served for two mandates as Chairperson of this Committee (2012-2018). Additionally, Bruno is also member of the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) and of the Committee of Advanced Therapies (CAT). In November 2018, Bruno was elected Vice-Chair of the Committee of Human Medicinal Products (CHMP).

• 

  Jorge Batista

  • Professional Affairs Advisor
  • PGEU, Belgium

• 

  Najla Chebib

  • Co-founder & CEO
  • OrCa, Switzerland

  Najla Chebib is a medical dentist, specialized in reconstructive dentistry and gerodontology and a lecturer at the University of Geneva in the removable prosthesis and gerodontology division. She has held several teaching positions at Saint-Joseph University in Lebanon but also at Tufts University in the United States. She divides her time between research, teaching, and clinical activities. Her research interests focus on simplifying prosthesis fabrication techniques with intra-oral digital impressions and printed or milled prostheses. She is also interested in strategies that highlight how certain diseases such as malnutrition or pneumonia can be avoided by maintaining a healthy and functional mouth.

• 

  Lucia Perez-Kempner

  • Senior Consultant
  • Parexel International, Spain

  Lucia is a bilingual senior health analyst with post-graduate education in global health policy, health economics, and business administration, and a professional degree in pharmacy. She has 8 years’ experience working in the public and private health sectors. Her work is focused on providing health expertise and leading teams to build health networks and partnerships, advance public health efforts, improve health system delivery, develop models to increase access to healthcare, strengthen health systems, and assess and evaluate health policies.

• 

  Elizabeth Vroom

  • President
  • Duchenne Parent Project, Netherlands

  Founder and President of the Duchenne Parent Project Netherlands since 1995, Chair and co-founder of the World Duchenne Organization and board member of Eurordis. She is the mother of an adult son with Duchenne MD & orthodontist by training; chair of the Ethics Board & member of the Executive Committee of TREAT-NMD; volunteer for Eurordis; a patient expert for the European Medicines Agency. Involved in several publications regarding Standards of Care and drug development for Duchenne Muscular Dystrophy, concerning development of outcome measures & role of Biomarkers. She is co-author of a handbook on psychosocial aspects of DMD. She participates in several EU funded projects, such as Asterix, Adapt Smart, RD-Connect Vision-DMD & Share4Rare.

• 

  Weidong (David) Yu, PhD

  • Senior PK Scientist
  • Biopharma Services , Canada

  Dr. David Yu is an accomplished PK scientist with over 20 years of experience in drug development, clinical trial and pharmacokientics studies. Currently, David Yu is a Senior PK Scientist at BioPharma Services Inc, where he leads PK studies for multiple investigation candidate across a range of therapeutic areas. He is also involved in the development of novel PK methodologies and serves as a mentor to junior scientists in the PK group. he is passionate about advancing the field of PK and improving drug development outcomes through innovative PK approaches."

• 

  Kasper Bendix Johnsen

  • Head of Section
  • Danish National Center For Ethics, Denmark

• 

  Bunmi Femi-Oyekan

  • Director, Regulatory Affairs
  • Pfizer Specialities Ltd, Nigeria

• 

  Ansgar Hebborn, PhD, MBA

  • Head - Access Policy Affairs Europe
  • F. Hoffmann-La Roche AG, Switzerland

  Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.

• 

  Deepika Lakhani

  • Vice President, Regulatory and Quality
  • PAVmed Inc., United States

  Prior to her current role, Deepika was at AstraZeneca Pharmaceuticals in Global Regulatory Affairs and has also spent nearly 11 years at the FDA where she started as a reviewer in Center for Drugs Evaluation and Research (CDER) and subsequently served in multiple positions in CDER and Center for Devices and Radiological Health (CDRH) involved with the review of medical devices, drugs, biologics, and combination products. Deepika considers regulatory affairs to be a creative process that enables innovation. She has multiple peer-reviewed publications and received many awards for excellence and leadership while at the FDA. She holds a Ph.D. in Pharmaceutics from Virginia Commonwealth University.

• 

  Patrick Middag, MBA, MSc

  • Principal Lead Regulatory Affairs
  • Servier, Belgium

  Patrick Middag, M.Sc., MBA, currently works at Veeva Systems where he focuses on helping life sciences organisations to derive business value & benefits and on all aspects revolving around Regulatory processes, data and organisation. In particular, how customers can get their data strategies, governance and business processes in order to be fully prepared as global requirements are forming. Before being a consultant, Patrick was leading the EU alignment of Global Regulatory IT initiatives at Bristol-Myers Squibb. He was the vice chair of EFPIA’s ERAO and an active member of EMA's SPOR Task Force. He has been working for mid-size pharma companies since 2001, in Enterprise Architecture, business-IT strategic alignment and process improvement.

• 

  Cornelia Weber

  • Regulatory Assessment
  • Swissmedic, Switzerland

• 

  Zilke Claessens, MHS

  • PhD Researcher
  • KU Leuven, Belgium

  Zilke Claessens (MSc) is a doctoral researcher at the research unit Clinical Pharmacology and Pharmacotherapy at the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven. Her research focuses on regulatory, health policy, and market access aspects of innovative drug research and development. More specifically, she applies qualitative and quantitative research techniques to align stakeholders understanding of the unmet medical need concept and develop incentive structures that support drug R&D to focus on areas with the highest unmet medical needs.

• 

  Fredrik Harenstam

  • VP of Business Development
  • Elypta, Sweden

  Fredrik is the VP of Business Development and acting head of Marketing & Sales at Elypta. Prior to Elypta he led the Nordic Technology & Innovation Management practice at consultancy Arthur D. Little, where he spent nearly a decade working with bringing new technology to market and working with healthcare payers and providers on medical devices, diagnostics, innovation partnerships, and digital health initiatives. Fredrik holds an Industrial Engineering M.Sc. in innovation management and financial mathematics from the Chalmers University of Technology.

• 

  Sabine Schneider

  • Vice President Global Government Relations
  • Labcorp, Switzerland

  Sabine Schneider has over 25 years of experience in Government Affairs, Marketing, and Corporate Communications in fast moving, competitive business environments. Her current role includes responsibilities such as the development of the Global Government Affairs strategy, the identification of top policy trends as well as strengthening and developing networks to key authorities, government officials, associations, opinion leaders for the company. Prior to this role she worked at the European Headquarters of eBay Inc. in Switzerland as the Head of Corporate Communications. She holds an Executive MBA in Communications and Science of the University of Lugano, Switzerland.

• 

  Boitumelo Semete-Makokotlela

  • CEO
  • SAHPRA, South Africa

  Dr Boitumelo Semete-Makokotlela is the CEO of the South African Health Products Regulator. She has a Ph.D. (Biochemistry) and also holds MSc in Management Finance and Investment. She is also a fellow of the African Leadership Initiative. Within the technology innovation space, she managed a biotechnology incubator at The Innovation Hub Management Company. She was with McKinsey & Company for two years as a McKinsey Leadership Fellow. Prior to that, she was at the CSIR as a Senior Researcher.

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  Petra Bettendorf

  • Head of Regulatory Affairs Region
  • Boehringer Ingelheim International GmbH, Germany

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  Laura Oliveira

  • Regulatory Affairs, Director
  • MSD Spain , Spain

  A Regulatory Affairs professional with more than 15 years experience. Extensive Health Authority experience and knowledge of European regulatory legislation and licensing registration procedures. Excellent negotiation and problem solving skills gained in a wide Regulatory Affairs experience on behalf of national and international organizations. Elected Chairperson of the Coordination Group of Mutual Recognition and Decentralized Procedures - Human.

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  Jorge Batista, MPharm

  • University of Algarve, Portugal

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  Bjorg Hunter, MSc

  • Director
  • Novo Nordisk, Denmark

  Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK in 2010 where she has held positions with increased resistibility stating in the device development area both in R&D and Regulatory fields. In 2020 Bjorg took up a new position in NovoNordisk where she is leading the RA Device Combination Products department and in 2022 moved to a position as Director of RA Digital Health within RA CMC and Devices. Bjørg has also been very active in external advocacy, including driving industry positions on behalf of EFPIA.

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  Andrew Bruce

  • Health Policy and Reimbursed Director
  • Amgen, Belgium

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  Tim Chesworth

  • Senior Director Regulatory Affairs
  • AstraZeneca, United Kingdom

  Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices. Tim’s current role is to lead the Medical Devices & Combination Products group within AstraZeneca Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim is a leading member of a number of medical device & combination product industry groups and associations.

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  Philippe Page, DrSc

  • Head of Research Council, Trustee
  • The Human Colossus Foundation, Switzerland

  Dr Philippe Page is a physicist with a PhD in particle physics and 20 years of experience in international finance, including COO of a swiss private bank. His dual technical/managerial expertise lies in information management and governance. He is currently CEO of MeDDEa Solutions AG and Chair of the Board of Trustees of the Human Colossus Foundation, where he develops an alternative, user-centric governance model and tooling for digital interactions: DDE-Dynamic Data Economy. Philippe applies his expertise to the digital transformation of public and private organisations. In healthcare, his work is on distributed governance, allowing patients engagement in a multi-stakeholders environment, including regulators.

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  Klaus Hammer

  • Head of Regulatory
  • PeriVision, Switzerland

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  Francoise Sillan, MD

  • EU1 UK QPPV
  • Ipsen, France

  Françoise is a medical doctor as background, working in Pharmacovigilance for more than 30 years in big Pharmaceutical companies with different managerial roles, interactions with Health Authorities, and coordination of international networks of Pharmacovigilance. She has spent 15 Years on Vaccine Pharmacovigilance where she contributed to the development of standards definitions and methods through CIOMS WHO working groups on vaccine safety. Within the EFPIA Pharmacovigilance expert group, she analysed the influence of EU pharmacovigilance regulations outside Europe and of non EU regulations on the EUQPPV role.

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  Delese Mimi Darko, MBA, RPh, RAC

  • Chief Executive Officer
  • Food and Drugs Authority, Ghana

  Delese Mimi Darko graduated as a pharmacist with an MBA. She has a 28-year career in regulation of food and health products. She rose through the ranks of the Food and Drugs Authority to become its first female Chief Executive Officer in 2017. She led FDA’s designation as a Regional Center of Regulatory Excellence in Medicines Safety, Clinical Trials and Drug Registration. She contributed to the growth of research and of the local manufacturing industries in Ghana Mimi Chairs the Steering Committee of WHO African Vaccines Regulatory Forum and serves on several international and local expert committees. She has received several awards for her exemplary work. She is a devout Christian and married with two children.

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  Basem Higazy

  • Co-Founder & CEO
  • Consulto Care, Switzerland

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  Sina Schader, DrMed

  • Head of QPPV Office and EU QPPV
  • AbbVie, Germany

  Sina is the Head of the QPPV Office & EU QPPV in the department Pharmacovigilance and Patient Safety and located in Germany. She has been with Abbvie 14 years. Prior to joining Abbvie, Sina studied veterinary medicine and wrote her PHD thesis in the Virology department, working group Immunology on bone marrow transplantation. In her free time, Sina loves spending time with her husband and two little girls and enjoys horse-riding.

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  Ronnie Harprit Mundair

  • Regional Labelling Head - AfME, Canada and LATAM - Senior Director
  • Pfizer, United Kingdom

  +20 years’ of experience working in both the public & private sector of Regulatory Affairs (RA). Her career started at the MHRA - the UK RA & then moved into UK & EU regulatory strategy roles at both AZ & then Pfizer. In each of these roles she gained valuable experience across multidisciplinary aspects of RA ranging from Strategy, Labelling, CMC, Submissions, Artwork to Clinical Trials. In 2009, Ronnie moved into Labeling, managing diverse roles within Global & Regional functions at Pfizer. Ronnie’s responsibilities have included projects spanning labeling activities across EUCANZ, EME, AfME, Canada &LATAM. Currently a key focus for Ronnie is internally & externally leading on the topics of health literacy and ePI across LATAM, AFME, EU.

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  Edith Frénoy, MA, MSc

  • Director, European Public Policy – Strategic EU Advocacy Lead
  • MSD Europe Inc., Belgium

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  Aleksandar Ruzicic

  • Chairman and CEO
  • Almasan AG, Switzerland

  As a consultant and board advisor, Aleksandar provides strategic vision, people leadership and managerial oversight to corporations. As an Entrepreneur (and Intrapreneur for clients), he helps build-up fast-growing (novel) businesses for new and established corporations. In his volunteer roles within the INSEAD alumni healthcare community, and in the past the Digital Health Alliance, as occasional guest lecturer at universities and as trusted coach to his long-term clients and (past) colleagues, he supports the professional development of healthcare/ life sciences leaders.