Barbara Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative effort to improve standards for the planning, conduct, and regulatory environment of international clinical trials. She is the Director of the Regulatory Foundations, Ethics, and the Law at the Harvard Catalyst (https://catalyst.harvard.edu) and Director of Regulatory Policy for SMART IRB (www.SMARTIRB.org). She currently serves on the BODs of Management Sciences for Health, Edward P. Evans Foundation, and Vivli.

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.

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.

Tamara is a Regulatory Policy Lead at Roche in Switzerland, focusing on EU policy topics, in particular Drug Repurposing, Orphan Medicines and the General Pharmaceutical Legislation. She joined Roche in 2013 and has held roles of increasing responsibility across different business areas. Additionally, she was a project manager and policy advisor at EFPIA (on secondment) from 2021 until 2023. She holds a MA in International Relations and is currently completing an MBA at Warwick Business School.

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.

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.

Dr Dave Lewis is Visiting Professor of Pharmacovigilance within the School of Life and Medical Sciences at the University of Hertfordshire, UK. Dave worked for over forty years in Patient Safety and Pharmacovigilance at GSK, Shire and Novartis. He was an active contributor to the ICH E2B (electronic reporting) and E2D (post-marketing data management) Expert Working Groups. He led the Innovative Medicines Initiative WEB-RADR project focusing on pharmacovigilance and social media, and was Co-Lead for Work Package 2 of the IHI ConcePTION project, researching pharmacovigilance in pregnancy and breastfeeding. PUBLICATIONS: Bibliography of ~40 publications on pharmacovigilance can be provided upon request.

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.

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.

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.

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.

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.

Pär Tellner is Director EFPIA since 2012 and member of ICH Management Committee and Assembly since 2016. Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical companies, e.g Octapharma, Biovitrum, Pharmacia Plasma Products and Novartis. Pär has also been working as Senior Pharm. Officer for the Swedish Medical Products Agency. Pär graduated as a pharmacist at Uppsala university in 1986.

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.

Sarah Adam coordinates IFPMA activities in the Regulatory field focussing on policy, regulatory system strengthening and harmonisation. She also leads Regulatory Science Policy for Africa. Prior, Sarah worked for many years, for ICH, supporting the harmonisation of ICH technical Guidelines and requirements for pharmaceutical product registration. She also dedicated over 10 years of research in academia in the field of pulmonary disease preclinical drug testing and vaccine development. Sarah was an appointed lecturer at the School of Pharmacy at the University of Geneva, she holds a PhD degree in Molecular Biology and an Engineering degree in Biotechnology.

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.

Dr. Peter Arlett leads the Data Analytics and Methods Taskforce at the European Medicines Agency (EMA), overseeing clinical evidence, real-world data, AI, and safety reporting. He chairs the EMA Data Board and co-chairs several key groups, including the HMA-EMA Big Data Steering Group and the Vaccine Monitoring Platform. Before joining EMA in 2008, Dr. Arlett worked at the European Commission, served as a UK delegate to the European Committee for Human Medicinal Products, and held roles at the MHRA. He trained as a physician in Oxford and London, holds a medical degree from University College London, and is Honorary Professor at the London School of Hygiene and Tropical Medicine.

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.

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.

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.

Dr. Niklas Blomberg, IHI's Executive Director since January 16, 2024, has vast experience in life sciences research and leadership. With a background in chemistry and a PhD in structural biology and bioinformatics, he worked at AstraZeneca for 14 years, leading data-driven drug discovery. As industry co-lead of Open PHACTS, he contributed to IMI. As ELIXIR's founding director, he facilitated its establishment and growth to 23 member states, securing funding from the EU.

Ane Sofie Böhm Nielsen, VP of Global Regulatory Affairs Policy and Intelligence at Novo Nordisk A/S, has been driving policy functions there since 2013, transitioning to Global Regulatory Affairs in 2015. Committed to ensuring compliance with new regulatory requirements, she engages in meaningful dialogues with external stakeholders on regulatory science trends. Currently focused on the EU General Pharmaceutical Legislation revision, Ane Sofie previously led the health policy department at Burson-Marsteller Public Affairs in Brussels and served as a Public Policy Manager at Roche in Basel. She holds an M.Sc. in Public Administration from Aalborg University and an M.A. in International Relations from the University of Kent at Canterbury.

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.

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.

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.

Aude Clement is a Senior Director in the Pharma Development Regulatory team at Roche. She currently contributes to building the organizational capability for digital technology based drug development tools and personalized healthcare digital solutions. Aude has two decades of experience in the Pharma industry, as a global regulatory lead and regional strategist for innovative medicines across modalities and therapeutic areas at Roche, Novartis, Sanofi and Pfizer. She holds a French Doctorate in Pharmacy and Master’s degree in International Drug Development & Registration. She recently completed the Quantic School of Business & Technology Executive MBA.

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.

Natashia De Casamassimi is a molecular biologist by training and is currently Head of Regulatory Affairs at ProductLife Group. In her role, Natashia leads a group of 150+ people, is a permanent member of the PLG operating committee, and provides leading Strategy Advice Management. She is also responsible for Solution Management from both Sales and Operations perspectives, managing mid- to big-sized portfolios. With over 24 years of expertise in the Pharmaceutical sector, she has extensive experience with international and local consultancy and know-how in international, EU, and local regulatory requirements.

Regulatory Affairs Director at IQVIA with more than 20 years regulatory experience, including both CRO and pharmaceutical industries. Oversight Regulatory Affairs Lead for long-term lifecycle management projects. Mentor for IQVIA Project Leads.

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.

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.

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.

Dr Gabaldo has more than 20 years of experience in drug development spanning from chemicals up to ATMP. Currently Vice President ATMP Global Regulatory Affairs at EVOTEC. Master degree in Pharmaceutical Chemistry and Technology and Master degree in Regulatory Affairs & Market Access for Chemicals and Biopharmaceuticas. Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans. Currently member of the IRDIRC Regulatory Scientific Committee.

Alberto Ganan Jimenez is a Pharmacist and a Biochemist and holds a PhD on Molecular and Cell Biology from University of Zaragoza (Spain). After working in Pharmaceutical Industry in Business Intelligence positions, Alberto joined the EMA in 2006 as a Product Lead in the Quality of Medicines Office. In 2013, he was appointed Head of Procedures office and since 2022 he is leading the Committees and Quality Assurance Department. This department hosts the secretariat of the Scientific Committees and Working Parties and the Expert panels on Medical devices, provides quality assurance on regulatory and labelling aspects of medicines and is responsible for the procedural management of minor variations and validation of initial MAAs.

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.

Heidrun Hildebrand has 30 plus years’ experience in drug development. Heidrun started her carrier in the Pharmaceutical industry as Quality Manager within Clinical Development and held different positions with increasing responsibility. Since 2017 Heidrun is part of the new Therapeutic Area Pediatric Development at Bayer. Heidrun is one of he co-leads of the EFPIA Consortium driving the IMI2 initiative to create a pan-European Paediatric Clinical Trials. Network.

Martin Keller is Co-Founder and CEO of Acodis, a Swiss-based AI company with the mission to turn documents into business value. Martin has a background in strategy consulting and a passion to deliver high-value solutions for customers. He holds a MBA from IESE in Barcelona and Master's in International Relations from the Graduate Institute in Geneva.

Hannes Kulovits is Senior Customer Portfolio Lead (I-CA-HMS), and Value Stream Manager of the Product Lifecycle Management Value Stream at the European Medicines Agency. In this role he is responsible for the digital transformation and optimisation of regulatory procedure management, as well as data submission and reuse, throughout the product lifecycle.

Florian is a Biostatistician with a degree in mathematics and a PhD from Hannover Medical School. Florian works as a Biostatistics Specialist at the European Medicines Agency, providing scientific support to development and evaluation throughout all stages of marketing authorisation assessments of medicinal products, and leads the ACT EU Priority Action on Clinical Trial Methodologies.

Melly Lin is working at F. Hoffmann-La Roche Ltd. as CMC Regulatory Policy Lead. She is responsible for identifying policy priorities and supporting regulatory policy advocacy efforts for South East Europe, Central Asia and Egypt. She has over 20 years of experience in Regulatory Affairs, within that 13 years in CMC Regulatory Policy. She joined Roche China in 2004. There she held different positions with increasing experience and responsibility in regulatory filing. She took the responsibility as China Policy Lead from 2011 to 2019. She is now taking an active role in the middle east region by leading the EFPIA MERN LCM team. She is also chairing an industry network for South East Europe.

Mrs Lindström is the Chair of the ICH Assembly. She is working as a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is in charge of international relations in the field of pharmaceuticals. Mrs Lindström has over 20 years experience in the European Commission, including over 10 years in the field of pharmaceuticals. She holds a Master of Laws degree from the University of Helsinki, Finland.

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.

Victor Maertens is the Government Affairs Director for the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Victor leads EUCOPE’s policy work in the area of Orphan therapies and Cell and Gene Therapy. Prior to joining EUCOPE, Victor worked for Brussels-based consultancies, providing pharmaceutical companies, trade associations, and NGOs with advocacy, strategy, and communications advice. His experience and interests include ATMPs, rare diseases, AMR, and neglected tropical diseases.

Ania Mitan serves as the Senior Vice President & Managing Director, EMEA and India. She is former Executive Director of the commercial organization at Celgene, where she built the oncology business in the EMEA region with healthcare partners to shape quality delivery systems and new commercialization models in personalized medicine, specifically with novel cell and gene therapies. She began her career at Eli Lilly and Company, serving as Head of Commercial Development for EU mid-size countries, Head of Primary Care Business Unit for the UK and Ireland, and Head of Marketing for the Critical Care Unit. Ania earned her MBA from Simmons College and MSc in Pharmacy from Silesian Medical Academy (Poland).

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 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.

Julie is a regulatory affairs professional specialising in European and International regulatory policy with impact to innovative medicines. She focuses on advancing science-based regulatory policy, including in the area of global regulatory system strengthening. In her role, she implements strategic regulatory policy initiatives and develops recommendations to address regional regulatory policy challenges. She has over eighteen years industry experience and is a member of the Regulatory Science Committee of EFPIA and is a member of the Regulatory Science Committee of IFPMA. She holds a Ph.D. in the area of immunology and vaccine development from Trinity College Dublin.

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.

Matias Olsen is the Public Affairs and Policy Manager for the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Matias supports EUCOPE on key topics, including the implementation of EU HTA, advanced diagnostics, RWE, the Patent Package, Europe’s Beating Cancer Plan and relevant market access topics. He coordinates members’ thematic working groups, including the P&R/Market Access Working Group, the Genomics Working Group and the EU HTA Regulation Task Force. Matias has previously advocated on behalf of European cancer patients and worked in the Norwegian Social Security Administration, with reimbursement of medical devices and coordination of social security within the EU/EEA.

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.

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.

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.

Helena Pedrosa, with 11 years' pharmaceutical industry experience, joined UBC in Oct 2012. She's served as Safety Data Associate, Scientist, & Team Manager. Dr. Pedrosa excels in end-to-end case processing, regulatory compliance, & scientific literature monitoring for PV. Currently managing operational teams for case processing, expedited reporting, literature monitoring, safety database configurations, reconciliation activities, & local PV. Holds a Pharm D & PhD in Toxicology from University of Porto.

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.

Experienced student with a demonstrated history of working in the non-profit organization management industry. Skilled in Team Motivation, Health Advocacy, Communication, Supervisory Skills, and Teamwork. Aiming to become a strong business development professional with a Master of Pharmacy - MPharm focused in research, pharmaceuticals industry, regulatory affairs and health advocacy - from University of Mostar - Faculty of Pharmacy.

Daniel Reed holds a PhD and has a global publication record in cardiovascular pharmacology and cell therapy from Imperial College London. With a diverse background, he's been a biomarker specialist, worked in patient advocacy, and collaborated with regulators on stem-cell-based screening tools. In the past decade, he has worked as an expert intelligence professional, serving as an analyst, consultant, insights lead, and business leader across various therapeutic areas. Currently leading the Intelligence and Policy group for Cardiovascular-Renal-Metabolic at AstraZeneca, he collaborates with leadership and regulatory teams, providing strategic direction on intelligence and policy matters.

Sofia holds a Chemical Engineering degree from the Instituto Superior Tecnico, Lisboa, Portugal and a PhD in Biochemistry from the Universität Bayreuth, Germany. She has over 25 years industry experience in various companies in Biotech as well as Pharmaceuticals working in varied areas of basic research, early- and late-stage development as well as lifecycle of small molecules, mRNA, biologics, and combination products. For the past 10 years she has been working at Bayer in the global organization in Quality and more recently she took the lead for Global Regulatory Affairs CMC responsible for global CMC strategy for Bayer Pharma.

Sophie is Managing Partner at Partners4Access (P4A), a global consultancy 100% focused on orphan drug access. P4A support the biotechnology and pharmaceutical industry along their launch journey to help secure successful price, reimbursement and access for orphan drugs. The company has solid partnerships with clients supporting their strategy and operations to effectively ensure launch success. Sophie has worked in a range of disease therapy areas and has industry experience in both medical device and pharmaceutical industries, as such she has developed a solid appreciation of strategic challenges and opportunities facing companies.

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

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.

Rabia Sucu, President of HTAi 2023-2025, is a Senior Principal Technical Advisor at MSH, leading the HTA and Market Access Cluster. She advises the USAID-funded SAFEMed project, supporting the Ukrainian government in priority setting, HTA institutionalization, reimbursement, pricing, verification, and bioequivalence. Formerly Director of ANHTA, a professor, national clinical quality coordinator, and member of various committees, she has published over 150 articles, delivered 300 presentations, and edited 8 books.

Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines Agency and World Health Organization, in addition to MHLW. He has a wide range of experience in pharmaceutical regulation such as marketing authorisation, pharmacovigilance, supply chain and drug pricing. He joined PMDA in June 2022 and worked to develop its next 5-years mid-term plan. Since July 2023 he has been in current position. He is a pharmacist by education and holds a Ph.D. in Pharmaceutical Science from the University of Tokyo.

Charlotte is the Vice President of European Affairs at EPSA (European Pharmaceutical Students Association) and a Trainee at EFPIA (European Federation of Pharmaceutical Industries and Associations) in the Science Policy and Regulatory Team. With a pharmaceutical background, Charlotte is currently based in Brussels as a young advocate for pharmaceutical students.

Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s biosimilar market access group. An adjunct professor at the University of Copenhagen, Dr. Thirstrup has authored over 40 publications and co-edited a key Danish pharmacology textbook. He divides his time between Amsterdam and Værløse, Denmark.

Michal Timler, Director of the eCValidation Department at eConsulting Ltd. Associated with the pharmaceutical industry for more than 18 years. He has led activities related to validation processes and the design, installation and operational qualification of installations, facilities, equipment. For nearly 10 years involved in the subject of validation of computer systems. Long-time member of ISPE (International Society for Pharmaceutical Engineering) -conducted training courses in the areas of Treated Water and HVAC, among others. Currently, as Director of Validation, he manages a team of several dozen people, which carries out a variety of projects in the areas of validation, qualification, audits and implementation (GMP, MDR, IVDR).

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

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.

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.

James Whitehead is the Senior Director, Device & Digital Safety at AstraZeneca working within Global Patient Safety, having started his career with AZ as a Pharmacovigilance Scientist in Oncology. Since graduating with a BSc in Psychology from the University of Leicester, James has held positions at CROs, Pharmaceutical Companies and Consulting Practises with a focus on Signal and Risk Management. That passion for Signal and Risk Management culminated in a MSc in Pharmacovigilance from the University of Hertfordshire, James is now a Visiting Lecturer on the course. Recently, James studied for an MBA and focused this project on innovation and digital transformation within Patient Safety.

Amira is the Global Regulatory Policy Director for 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 Southeast Europe industry network. 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.

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.

Elina Asikanius is a statistician at the Finnish Medicines Agency. She is also a member of the EMA Methodology Working Party and the EMA Scientific Advice Working Party. She joined FIMEA 2020 and before becoming a regulator she worked over 10 years in the pharmaceutical industry with broad responsibilities.

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.

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.

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.

Regulatory Affairs Professional with over 20 years of experience in the innovative pharmaceutical industry. Leading Regulatory Affairs teams Croatia & Bosnia and Herzegovina at Merck Sharp & Dohme. Prior joining industry spent 8 years in academic settings at the Department of Pharmacology, Medical Faculty, University of Zagreb, Croatia. By profession, I am a pharmacist, and I have also completed post-graduate studies in the field of Natural Sciences. As Regulatory Affairs professional I feel privileged to contribute to bringing innovative medicines to patients and to follow the product throughout life cycle. As Regulatory Affairs Policy Manager I am excited to be actively engaged in the development of new pharmaceutical regulation.

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.

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.

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.

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.

Isabelle Huys has a PhD in pharmaceutical sciences from KU Leuven (Belgium) and an LLM in IPR and regulatory sciences from the Max-Planck-Institute (Munich, Germany). Since 2010, she is a full-time professor in regulatory sciences at the Faculty of Pharmaceutical Sciences and a member of the Center for IT & Intellectual Property IT law (CiTiP) of KU Leuven. Isabelle Huys has been Advisor for European Projects, Intellectual Property Officer and Regional Development officer at the KU Leuven R&D department. She did post-doctoral research at the Law Faculty of KU Leuven on patents and biomedical inventions. Isabelle Huys is deputy co-ordinator of PREFER and also academic leader for the work package on recommendations.

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.

Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s strategic priority to facilitate the uptake of advanced manufacturing approaches in EU and is part of the ICMRA PQKMS group. She has trained as a pharmacist in the School of Pharmacy of the University of Athens and has received a M.Sc. and a Ph.D. in Pharm. Technology from the same Faculty.

Hubert (Bert) G. Leufkens is emeritus professor of Pharmaceutical Policy and Regulatory Science at Utrecht University, the Netherlands. He is research and policy-wise active at several (inter)national platforms on regulatory science, innovation, drug safety, and pharmaceutical policy (e.g., past-member EMA Pharmacovigilance Working Party, chair of Dutch Medicines Evaluation Board (MEB), past-member of the EMA CHMP, past-President of ISPE, former Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. He is vice-president of the European Federation for Pharmaceutical Sciences (EUFEPS), and (co) author of >600 papers in peer reviewed journals, book chapters and research reports.

Tom Metcalfe graduated in Biochemisty from King's in London and has an MBA from the Open University. He currently works in the Ecosystems team in Roche Pharma's Personalised Healthcare Centre of Excellence. He also represents Roche Pharma in the EFPIA Innovation Board Sponsored Committee. Prior to that he worked for Roche as a Strategic Innovation Leader in Global Development from 2015 to 2018. He served as CEO of Oncotest GmbH, a CRO providing preclinical profiling services in Oncology from 2011 to 2104 and worked for Roche Pharma and Diagnostics in a variety of roles from 1993 to 2011 including as Head of the Personalised Healthcare Portfolio and the Roche Biomarker Program.

+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.

Dr Martin O'Kane, MRPharmS, studied pharmacy at University of Aston and after completing a PhD and a post-doctorate research project at the University of Glasgow, he moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist with the British Pharmacopoeia and was a member of the European Pharmacopoeia Commission’s Working Party on Cell Therapy Products. He moved to the Clinical Trials Unit as a Pharmaceutical Assessor in 2007 and was involved in the assessment of chemical and biological CTA applications for all phases of study. In 2023, becoming the Regional Head RA EU Policy & Liaison at Novartis.

Chrissi Pallidis, MD, graduated in Greece in 1995, and trained in pediatrics at UK hospitals, including University Hospital Wales and King’s College Hospital London. She worked as a general pediatrician in the UK and Greece. From 2005 to 2012, Dr. Pallidis was a senior medical assessor at the UK's Medicines and Healthcare products Regulatory Agency, specializing in clinical assessments. In 2012, she joined the European Medicines Agency, focusing on pediatric investigation plans and specializing in pediatric gastroenterology and hepatology. She also serves as the scientific lead for the Pediatric Committee (PDCO).

Claudia Percivalle is a global regulatory affairs professional with broad experience across various regulatory fields and therapeutic areas including cardiovascular, rare diseases, and neurology. Claudia successfully led global teams in early development (CTA/IND) and late development/product lifecycle (MAA/NDA/ANDA/sNDA) projects for EU, North America, MENA, and APAC markets. As Regulatory Affairs Director at AstraZeneca since 2022, she provides strategic directions to project teams within AZ CVRM portfolio. Previously, she served as Head of Regulatory Affairs & Clinical Development at Cycle Pharmaceuticals Ltd. Claudia holds a PhD in organic chemistry and has published her research in prestigious chemistry peer-reviewed journals.

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates the Health Data Lab at the European Medicines Agency and has several functions related to enabling the safe and responsible use of AI with healthcare data, including RWD. He has worked in the field of pharmacovigilance and drug safety for over 22 years, in academic and regulatory settings.

Olga Tkachenko graduated with an MSci and BA in biochemistry from the University of Cambridge and with a PhD from the University of Oxford, where she researched protein aggregation in neurodegenerative disease. She joined the medical devices team at the European Commission in December 2017, where she works as a Policy Officer. Her responsibilities include in vitro diagnostics, borderline products and establishment of EU reference laboratories. She is chair of the In Vitro Diagnostics sub-group of the Medical Device Coordination Group, which is the national competent authority group overseeing the implementation of Regulation (EU) 2017/746 on in vitro diagnostics.

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.

Esther de Vries is a pharmacovigilance assessor at the Dutch national agency (MEB), while finishing her PhD at the University Medical Center Groningen in the Netherlands. Her PhD centres around the Direct Healthcare Professional Communication (DHPC) in the hospital setting in the Netherlands. In addition to these activities, she is involved in digitalising the DHPC in the Netherlands.

Michael Rosenblatt, MD, Senior Partner at Flagship Pioneering, has advanced academic and biopharmaceutical research and development throughout his career. He was previously Chief Medical Officer for Merck, after serving as Dean of Tufts Medical School. Formerly, he was Ebert Professor of Molecular Medicine and Minot Professor at Harvard. He served as President of Beth Israel Deaconess Medical Center and as Director of the Harvard-MIT Division of Health Sciences & Technology. He is on the board of several life sciences companies, and on the Harvard Medical School Board of Fellows and research advisory committees of the Massachusetts General, Brigham and Women’s, and Boston Children’s Hospitals. He earned his MD from Harvard Medical School.

Barbara Briggs, PhD, has over 40 years of research and development (R&D) experience. Her journey began with research at Charing Cross Medical School, followed by a 9-years at Bayer Pharmaceuticals. She then transitioned into Development and Regulatory Affairs, accumulating over 9 years at GSK, followed by 8 years at Biogen, and currently, is a part of UCB. She has specialised in Labelling both at a Global and Regional level.

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.

Momir Radulovic leads the Slovenian Medicines and Medical Devices Agency since December 2018. He is a member of EMA Management Board, a member of EC Pharmaceutical Committee, HMA Management Group, Chair of EURIPID Board of Participants and member of EU Network Training Centre Steering Group. His previous work experience includes Hospital and Community Pharmacy and Pharma industry, focused on oncology medicines, HIV and vaccines. By living and working in countries with diverse Health systems and cultural environments he has learned to adapt swiftly to changes and to seize the opportunities that those can offer. He has track record of strong results, enjoy prioritizing, simplifying complex ideas and acting on them with high levels of energy.

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!

Agnès is a member of the Regulatory Science & Policy EU/AMEE team at Sanofi. She is a member of EFPIA sub-team on dynamic regulatory assessment (DRA) but also in IFPMA ATWG, ARM EU Regulatory groups and EFPIA IREG. Agnès has a PhD in Genetics, Molecular Biology and Toxicology at the University of Paris Saclay. She started her pharmaceutical industry career in Regulatory Affairs 25 years ago at Amersham/GE HealthCare, then at CIS Bio international/IBA, and at Sanofi from Sept 2015. She has a very large experience in GRA (Global, EU & International region, French affiliate, initial submissions, Life Cycle Management, CMC expert, Labelling, Regulatory operation, Science & Policy) and global quality.

Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make large, complex, and strategic decisions. In 2018 he pulled a Robin Hood with Decision Science and founded the Decision Skills Institute to share it widely. The Institute targets broad-reaching efforts like training large groups of employees and various patient populations. Tyler’s best decisions were marrying his wife and having their 10 children.

Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into medical writing. Passionate about improvement, she identifies best practices, develops new platforms, and fosters change within the organization. Prior to GSK, she was a Bio-Modeling Scientist at Cellworks Research Limited. Outside work, Eishita enjoys reading, painting, and spending time with loved ones.

Rainer Becker is director for Medical Products and Innovation in the Commission’s DG SANTE. His directorate is responsible, amongst others, for the follow-up initiatives to the 2020 Pharmaceutical Strategy for Europe, such as the revision of pharmaceutical EU legislation and policy initiatives on availability of medicines. It also leads the Commission’s policy work on medical devices and veterinary medicines. Rainer’s previous work includes heading, over years, the Commission’s antitrust enforcement in the area of pharmaceuticals, devices and health services.

Dr. Philippe Botteron has 8 years of experience in the pharmaceutical industry. He serves as a Senior Safety/Project Physician. In this role, he performs medical review of individual cases or safety reports, participates in writing periodic safety reports, performs signal detection and management, and writes company documents (e.g. CCDS) and regulatory documents (e.g. RMP). His fields of expertise are Oncology, Immunology, and Infectious diseases. He received his medical degree from the University of Geneva.

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.

Sneha graduated from Indiana University in May 2020, majoring in chronic illness advocacy and journalism. She founded Generation Patient to support young adults with chronic conditions nationwide and internationally, maintaining independence from private healthcare funding. Sneha's advocacy includes Capitol Hill speeches, C-SPAN features, and contributions to U.S. News and World Report. She joined ICER's Comparative Effectiveness Public Advisory Council and served on the FDA Patient Engagement Collaborative and in various grantmaking committees. Sneha received two academic fellowships from the Association of Health Care Journalists.

Petra Doerr has been Director of the EDQM since September 2021. She is a pharmacist/PhD and has spent the first ten years of her career in the medical products industry, working in international regulatory affairs. She joined Swissmedic in 2004 as Head of International Affairs and has been Head of Management Services & Networking and Member of the Management Board since 2007. From 2014 until 2019, she held the position of Head of Communication & Networking and Deputy Executive Director. Since 2019, Petra has been director and owner of Petra Doerr Consulting Ltd., providing consultancy services to not-for profit organizations. She has been Head of Unit Regulation and Safety at the World Health Organization from November 2020 to August 2021.

Helerin Eiche obtained her PhD degree in Cell Biology in 2016 and since then she has been working as a quality assessor for biotechnological medicinal products at the State Agency of Medicines (Estonia). She is mainly involved in the assessment of the quality part of clinical trial and centralised marketing authorisation applications. In addition, she is a member of the EMA Biologics Working Party (BWP). Helerin is interested in the development and life-cycle management of biopharmaceutical medicinal products with focus on monoclonal antibodies. Her other possession is the emerging field of phage therapy. She also aims to enhance awareness of environmental/sustainability issues in CMC within the EU regulatory network.

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.

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team.

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.

I'm an M.D., Ph.D. in Clinical Pharmacology based in Sweden. Since 2008, I've worked at the Swedish Medical Products Agency (MPA), leading Scientific and Regulatory Development. Since 2014, I've represented MPA at the European Medicines Agency's Committee for Human Medicinal Products (CHMP), acting as rapporteur for products in infectious diseases, oncology, and onco-hematology. Notably, I've worked on drugs like Sovaldi, Imbruvica, and Vitrakvi. I was in the CHMP's Scientific Advice Working Party from 2016-2020 and joined the EMA's Emergency Task Force for public-health emergencies in 2020.

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.

Oliver Koeth is Chief Technology Officer (CTO) for the DACH Region (Germany, Austria, Switzerland) at NTT DATA. Oliver joined NTT DATA in 2002 as Software Architect and was working in international system integration projects in NTT DATA's global automotive practice. As CTO Oliver advises clients on issues relating to new technologies in the areas of cloud, internet of things, customer experience, artificial intelligence, cyber security, and quantum computing and brings in the expertise of NTT DATA's global technology and innovation portfolio. He is also responsible for the global Agile/DevOps centre of excellence. Co-founded Enso, won BMW Quantum Challenge. Founded GenAI Office, developed Good GPT chatbot.

Jason has over 19 years of experience working in Pharma, 15 years of which have been with Johnson & Johnson Innovative Medicines. For the last 7 years, he has been a member of their Innovative Health team where he applies his strong technical and collaboration skills and global project leadership in delivering transformational innovation projects that have the goal to shape the future of clinical trial operations at Johnson & Johnson. Jason is Director of Innovative Health, he Focus Area Leader for Environmental Sustainability in Clinical Research, and he is leading the transformation of Johnson & Johnson Innovative Medicines’ global clinical operations towards sustainability.

Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.

Mic currently is an Associate Director of Global CMC Policy at Merck. He has over 32 years of experience with Vaccine and Biologics. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, post approval submissions globally, and evaluation of worldwide guidance's. For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for harmonization and greater access of medicines to patients.

Peter Mol is the Dutch member of the Committee for Human Medicinal Products. He was a previous member (vice chair) of EMA’s Scientific Advice Working Party. He is co-chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.

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Rafaella Pandini has extensive experience in Regulatory Affairs, Project Management, Pharmaceutical Consultancy, Licensing, QA Inspections, and Training. She holds a degree in Pharmaceutical Chemistry and Technologies from the University of Milan, and is currently the Regulatory Affairs Director at Pharma D&S a ProductLife Group Company. She is also involved in training activities within the Pharma Education Center.

Marketed Product Safety Ass. Director at IQVIA, with more than 10 years pharmacovigilance experience, including both CRO and Pharmaceutical industries. Oversight of Local QPPV Global Network.

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.

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.

Dr. Franz Schaefer, Pediatric Nephrology Chief at Heidelberg University Hospital, MD from Würzburg Uni. President of IPNA, his research covers genetic kidney diseases, disease progression, and renal replacement therapy. Leads ESCAPE and IPDN. Coordinates ERKNet, PodoNet, Global Registry, CompCure, EJP RD, ERICA. 700+ publications, H-Index 97. Edited 'Pediatric Kidney Disease' and 'Pediatric Dialysis'.

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.

Andrej Segec is a pharmacist by training (Comenius University, Bratislava, Slovakia) with an MSc in Epidemiology (London School of Hygiene and Tropical Medicine, London, UK). He has worked for the European Medicines Agency since 2008, in pharmacovigilance/signal management, monitoring of the EMA pharmacovigilance system, in surveillance and epidemiology, as committee manager for the operations of the Pharmacovigilance Risk Assessment Committee (PRAC) and as a risk management specialist for anti-infective therapies and vaccines during the COVID-19 pandemic.Currently, Andrej’s focus is on the generation and use of RWE in regulatory decision making and the establishment of the DARWIN EU®.

Nathalie Seigneuret is a Senior Scientific Project Manager at Innovative Health Initiative (IHI). She joined the Innovative Medicines Initiative the public private partnership predecessor of IHI in 2011. Prior to that Nathalie, who is doctor in pharmacy, worked for 16 years at EMA where she held various positions.

Kim Sherwood, Pharmacist and Senior expert assessor with more than 20 years of experience in Product Information and regulatory knowledge at the Swedish Medical Products Agency. Swedish delegate of the QRD group EMA since 2006. Project manager for the national ePI project since 2020 (electronic structured product information). Elected as one of the 4 ePI SMEs at EMA since 2022. International experience and network from EU National Competent Authorities and European Medicines Agency. Special interest in user testing and leadership in creative and agile teams.

Olga Solomon studied Chemistry at the Aristotle University of Thessaloniki, Greece and holds an MSc in Food Science from the Gothenburg University, Sweden. Before joining the European Commission she worked for 5 years for a beverage producing company in Greece. Solomon joined DG SANCO in 2000 and worked for 10 years in the field of Food Safety in particular dealing with legislation on Food Contact Materials, Food Additives and Enzymes. In 2010, she moved to the Directorate 'Health Systems and Products' where she worked in the field of substances of human origin before taking up a post in the pharmaceutical sector in 2011. She is currently the Head of the DG SANTE Unit responsible for Medicines: policy, authorisation and monitoring.

Jens-Ulrich Stegmann, MD, RN, is Senior Vice President, Head of Clinical Safety and Pharmacovigilance, and EU QPPV at GSK, Belgium. With an M.D. in nursing from the University of Essen and a Ph.D. in Physiology from Christian-Albrechts University in Kiel, Germany, Jens began his career as an anesthesiologist and emergency doctor at the University of Düsseldorf. He later joined Grünenthal, contributing to analgesic development before moving into Safety in 2008. Joining GSK Vaccines in 2012 as Head of Safety Evaluation and Risk Management, he became Deputy EU-QPPV, then Head of Clinical Safety and Pharmacovigilance. In 2019, he assumed the role of EU-QPPV for GSK and ViiV Healthcare and advanced to his current role in 2020.

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.

Iain has an educational background in both law and science and holds a Master's degree in Pharmaceutical Medicine. He started his career at Pfizer before joining GSK in 2011, where he is now a member of the Regulatory Policy and Intelligence team. Iain is currently Co-Chair of the EU Regulatory Intelligence Networking Group (EU RING).

Dr. Shinobu Uzu is the Senior Executive Director, PMDA and in charge of the Safety offices, Office of International Programs, and Regulatory Science Center since April 2020. He took Ph.D. in Pharmacy from the graduate school of the University of Tokyo and has over thirty years of experience in MHLW, PMDA. He worked for new drug review as Director of the Office of New Drug I and Associate Executive Director for new drug review, PMDA and safety management for drugs and medical devices as Chief Safety Officer, PMDA and Director of Safety Management, MHLW. He also worked for international affairs as ICH steering committee member on behalf of MHLW and 1st Secretary of the Embassy of Japan in Indonesia.

Maren von Fritschen is a recognized leader in Regulatory Affairs with 20+ years in Pharma and MedTech. With a PhD in Natural Sciences, she's now Head of Regulatory Policy Europe at Moderna, driving regulatory strategies for innovative technologies like mRNA. Maren built the regulatory arm at EUCOPE and was a foundational force behind PharmaLex, later founding AddOn Pharma as CEO. She's chaired DIA's Regional Advisory Council EMEA, contributed to TOPRA, and the STARS project. In the academic realm she is lecturing and mentoring master students at the University of Applied Sciences. Additionally, she has established a comprehensive scientific network across leading Universities in Brazil, focusing on medication in primary health care.

Glenn Wells, MHRA’s Chief Partnerships Officer, is skilled in activating inter-institutional partnerships for patient solutions. He joined MHRA in 2021 after working as the Director of Strategy at the UK Medical Research Council (MRC). At MRC, he developed national partnerships with academia, industry, and government and also established international relationships. Prior to MRC, Glenn built partnerships while working for the Oxford Academic Health Science Centre and the Wellcome Trust. The MHRA aims to achieve a Net Zero Healthcare system, and Glenn's keynote address will demonstrate how regulatory agencies can contribute to environmental sustainability through collaboration with industry.

David Montal, Co-Head of Pharma and Life Sciences at NTT DATA Europe and Latin America, holds a business administration degree from IESE. He completed a double degree in Telecommunications Engineering at ETSETB and Télécom Paris, with a research project at SRC College Park on supercomputing. With 25+ years of consulting experience, his focus shifted to life sciences in 2009. His mission: aid major life sciences firms in reaching strategic goals via innovative IT solutions. Passionate about applying AI and disruptive tech to R&D, he fosters collaboration, innovation, and growth within teams and with tech partners.

Sonja Beken is the Coordinator of the Unit of non-clinical evaluators at the Belgian Federal Agency for Medicines and Health Products. This Unit is responsible for the evaluation of non-clinical data submitted to support all phases of drug development. She is Chair of the 3Rs Working Party and member of the Non-clinical Working party at the European Medicines Agency. Over the years, Sonja Beken contributed to the direct identification of opportunities for regulatory implementation of 3R testing paradigms through her active involvement in large-scale international initiatives (e.g. ILSI HESI). Her main areas of expertise relate to regulatory science, non-clinical drug development, (in vitro) toxicology and metabolism and 3Rs.

Dr Bernardo is Responsible for the Pediatric Transplant Unit and Pediatric Allogeneic Transplant Coordinator of the Pediatric Immunohematology Unit, San Raffaele Scientific Institute. At SR-TIGET, she is Group Leader and Clinical Coordinator of the Pediatric Clinical Research Unit. She is Associate Professor of Pediatrics at Vita-Salute San Raffaele University Medical School, Milan. She is PI of the Phase I/II clinical trial of ex-vivo gene therapy for the treatment of patients affected by Hurler Syndrome. She is Co-author of >100 peer-reviewed articles published in international journals; H index (Scopus) = 45.

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.

Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy. Her activities advancing the environment for pediatric and maternal health include: ICH E11A Expert Work Group, C-Path International Neonatal Consortium, EFGCP Children's Medicines WP, IQ Consortia Clin Pharm Leadership Group Pediatric WG & NIH/NICHD National Advisory Council on Child Health & Human Development. In her career, Christina has over 40 peer-review published articles and 100 invited lectures.

Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 10 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of the Drug Information Association (DIA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Prior to joining CIRS, Magda carried out research spanning scientific, engineering and policy issues regarding the development of medicines. She received her Master of Science in Biochemical Engineering from University College London (UCL) and a Doctor of Philosophy from the University of Hertfordshire.

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy expert, she leads reforms, harmonization, and partner coordination, contributing to vital continental policies including the AU Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); and the AU Private Sector Engagement in Health Framework.

Catherine is a senior pharmacoepidemiologist in the RWE Workstream, Data Analytics & Methods Task Force, at EMA. She previously held various pharma positions, generating and evaluating RWE across all phases of medicine development, including vaccines. She also worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and the WHO International Agency for Research on Cancer in Lyon, France. Her work at EMA focuses on international guidance on RWE, and on public health emergency preparedness as Steering Group member of the EU Vaccine Monitoring Platform. She is co-chair of the ENCePP Steering Group and represents EMA in various RWE-related ICH initiatives.

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.

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes within the pharmaceutical industry. She currently works as a Regulatory Policy Lead at Roche Pharmaceuticals, focusing on RWD Policy.

Paul de Boissieu is the Chair of the Joint Clinical Assessments subgroup. He is a senior assessor in solid oncology and haemato-oncology at the Drug Assessment Division of the French National Authority for Health (HAS). He is a medical doctor with a PhD in pharmacovigilance and pharmacoepidemiology.

Nikos Dedes is Gen. Secretary of the Greek Patients' Association, chair of Positive Voice - the Greek Association of People Living with HIV, and Board Member of the EPF. He is currently member of the Steering Committee of NEAT id, member of the HIV Treatment Guidelines Panel of EACS and member of the SCs of the “HIV Outcomes” and “EuroTEST” initiatives. He is past chair of the EATG, past member of EMA Management Board, WHO Strategic and Technical Advisory Committee on HIV and DIA Europe’s RAC, having received the DIA Outstanding Service Award in 2014. Nikos advocates for universal access to evidence-based and cost-effective care and prevention services for all people as a moral imperative and pre-condition for a prosperous and fair society.

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.

Matthieu Hammer has been serving as the Head of Case Processing and Quality in Global Patient Safety Operations at Merck Healthcare KGaA since 2018. He has a strong focus on managing individual safety case reports (ICSRs), which has allowed him to develop expertise in case processing and monitoring ICSR submissions.

Megan Heath is Efpia Lead in the PILOT study within IMI Trials@Home project. Megan has 25 years of operational experience managing all phases of the drug development process. Megan started her career as a phase I research associate at Inveresk Clinical Research, UK before moving through various clinical operations positions in the industry. Megan joined Sanofi in Medical Affairs Clinical Operations and is currently the Head of Clinical Studies Units European Region. Megan graduated with a Bachelor’s degree in Pharmacology from Glasgow University before completing a PhD in Asthma Pharmacology at University of Manchester.

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

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).

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.

Dr. Niklas Jänich is Head of Global Labeling Operations & Digitization at Boehringer Ingelheim. In this position Dr. Jänich is responsible for Labeling process, systems, compliance and digitization as well as for driving the implementation of structured content management in the GxP-regulated Labeling process. Dr. Jänich is a certified pharmacist and holds a PhD in medicinal chemistry and a Master of Drug Regulatory Affairs.

Anna Litsiou is a Regulatory Policy and Intelligence Director with focus on International and China in AstraZeneca with more than 15-year experience in International Regulatory Affairs in different roles of strategy across therapeutic areas. Anna holds a PhD in Development Developmental Neurobiology from King’s College, London and an Executive MBA from Columbia Business School, London School Business and Hong Kong Business School.

Donald Lo is the Director for Medicines Development at EATRIS and Scientific Lead of the REMEDI4ALL European Platform for Medicines Repurposing. Don previously headed Therapeutic Development at the NCATS/NIH. Don joined the NIH following a 27-year academic career at Duke University Medical Center, during which time he also co-founded and led 2 biotechnology companies and a non-profit patient care organization for Huntington’s disease, and served as lead science advisor for a venture philanthropy organization for brain cancer. Don is a graduate of the California Institute of Technology, received his PhD from Yale University, and conducted postdoctoral research at the Ludwig Institute for Cancer Research at University College London.

Lilia Luchianov, of the European Commission's DG SANTE, has extensive experience in pharmaceuticals, previously in DG COMP. Currently, she focuses on revising pharmaceutical legislation and is involved in the legislative procedure. Lilia co-authored a handbook on EU Law of Competition and Trade in the Pharmaceutical Sector (2019), lectured on Competition Law and IP Law at the University of Strasbourg, and delivered numerous speeches on pharmaceutical, competition, and IP law. She holds an LLM in European Law from the College of Europe, Bruges, and a Master in Business Law from the University of Strasbourg.

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.

Christian Muehlendyck, MD, MBA, is Johnson & Johnson MedTech's Scientific Partnerships Lead for EMEA. He drives IHI activities, notably IDERHA establishment, and co-chairs MedTech Europe's Research & Innovation Committee. Beginning as a physician, he earned his MD/PhD while co-leading innovative medical device development, transitioning to MedTech industry to fuel his passion for innovation. With roles spanning medical training, commercial, and health economics, he's a key player in healthcare innovation and research, including value-based healthcare and digitalization like robotic surgery.

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

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.

Laura Pastor Sanz holds a position as Digital Health Policy Lead at Novo Nordisk, where she contributes to shaping the external regulatory environment for connected devices and software as a medical device, including the use of digital health technologies to derive digital endpoints. She is a member of the EFPIA subteam on Medical Device Software/Digital Health Technologies, and the EFPIA subgroup on Digital Endpoints. Previously, she has been working as researcher, project manager and fundraiser in collaborative EU-funded projects dealing with chronic conditions and technological innovation for a better health and quality of life. She holds a MSc. degree in Telecommunication Engineering and a PhD. in Biomedical Engineering.

Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China.

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.

Kyle Jacques, a diabetes advocate, amplifies the voices of those with diabetes, enhances awareness, and broadens access to care. He's been pivotal in mission-driven startups like mySugr (as its first employee), Bigfoot Biomedical, and TheraSense, as well as in NGOs like IDF and Diabetes Education and Camping Association. Notably, his ventures have led to major acquisitions or global agreements: Bigfoot Biomedical by Abbott Labs (2023), mySugr by Roche (2017), Team Type 1 with Novo Nordisk (2011), and TheraSense by Abbott Labs (2004). Living with Type 1 Diabetes for over 25 years, Kyle is deeply committed to transforming the landscape of diabetes management.

Katherine (Katie) Serrano is the Director of the Latin America Office in FDA’s Office of Global Policy and Strategy (OGPS). Before assuming this role in 2017, Ms. Serrano served nine years in the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health (CDRH). While at CDRH, Katie worked as a scientific reviewer, as the Diabetes Diagnostic Branch Chief and the Deputy Director of FDA's Division of Chemistry and Toxicology Devices. She also served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests.

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.

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.

Mr. Kenichi Tamiya is the Associate Executive Director for New Drug Evaluation at PMDA and is in charge of supervising the review of new drugs except for vaccines and regenerative medical products. Before assuming his current position in 2020, Mr. Tamiya was the Pharmaceutical Management Director, Medical Economics Division at MHLW and was responsible for Reform of Drug Pricing System. Mr. Tamiya has over 25 years' experience in MHLW, including new drug review at the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, post-marketing safety measures and promotion of R&D for innovative medical products. Mr. Tamiya holds a Master's degree in Pharmaceutical Sciences form the University of Tokyo.

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.

Sabina joined the Croatian Agency for Medicinal Products and Medical Devices (HALMED) in 2006, where she currently holds the position of Principal Regulatory Advisor. Her main responsibilities include coordination and overseeing regulatory procedures within the MRP/DCP in HALMED. She has been Croatian representative to the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) since the accession of Croatia to the EU, as well as representative to the NtA. She is also a member of several WG within the CMDh. She is a pharmacist with a postgraduate speciality study in clinical pharmacy.

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.

Peter van de Ven is a Biostatistician affiliated to both the Dutch Medicines Evaluation Board (CBG-MEB) and the University Medical Center Utrecht (UMCU). At the CBG-MEB, he works as a Methodology Assessor. At UMCU, he is an Associate Professor and Head of the Clinical Trial Methodology group within the Department of Data Science and Biostatistics. From 2009 to 2021, he was an Assistant Professor in Biostatistics at the Amsterdam University Medical Centers, location VUmc. He has been involved in design and analysis of trials across a wide range of medical disciplines, including oncology, cardiology and psychiatry. His methodological research focuses on innovations in clinical trial methodology, including adaptive and Bayesian methods.

Shruthi is an experienced leader in medical devices and combination products. She has experience across multiple platforms - combination products, electromechanical devices, consumables and digital health products and held roles within Device R&D as well as Regulatory Affairs. She is currently an Associate Director in RA Digital Health and IVD at Novo Nordisk. Prior to this, she worked at GSK, Pfizer and Hospira in various roles within Device Development. Shruthi has degrees in Electrical Engineering- (VTU, India) and an MS in Biomedical Engineering (University of Michigan, Ann Arbor).

Mrs Cathie Vielle graduated in Pharmacy in 1996 from the University of Strasbourg. Since 1996 she has held several positions in QA compliance and in supply chain departments in an international pharmaceutical company. In September 2005, she became Head of Quality Department at a manufacturing site for worldwide markets (e.g. Europe, USA, Japan). She joined the EDQM in May 2009, as Head of the European Pharmacopoeia Department.

Dr. Johan Vande Walle is member of the Faculty of Medicine and Health Sciences, Department of Internal Medicine and Pediatrics @Ghent University Hospital, Department of pediatrics University Hospital Ghent

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.

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.

Xenia, Senior R&D Project Manager at UPM-LifeSTech, heads Big Data projects and coordinated the PharmaLedger Project. With an Information Systems Engineering background, an MBA in International Management, and a PhD in Biomedical Engineering, she brings over 15 years of experience in Project & Innovation Management. She leads innovative projects, validating digitalization ecosystems and implementing changes across various sectors. She's coordinated large EU co-funded projects, overseeing 50+ innovative pilots in areas such as Digital Trusted Ecosystems, Big Data, IoT, Health & Wellbeing, Manufacturing, and Education.

Jayanthi Boobalan is Head of Emerging Market Regulatory Strategist Hub in Pfizer. Possessing over 17 years of experience in Regulatory Affairs, she has been an avid contributor in promoting regulatory convergence and has been actively involved in a number of environment shaping initiatives within the Asia Region. She is an active member of the EFPIA ASEAN Network and is a certified Good Registration Management (Good Submission Practice) trainer. She is a Registered Pharmacist and also holds an MBA in Global Business.

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.

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).

Antonella Cardone is the CEO of Cancer Patients Europe, a pan-European all-cancer patient association. She's a Patient Advocacy Expert and Advisor to the Board of Pancreatic Cancer Europe (PCE), uniting physicians, patients, politicians, journalists, academia, and industry, and she is a member of Inspire2Live. Antonella led the European Cancer Patient Coalition and served as Executive Director of the Fit for Work Global Alliance. With 25 years of nonprofit experience in health, social, and employment sectors, she also directed the Global Smoke-free Partnership of the American Cancer Society. Antonella holds Master's degrees in Science and Business Administration. She has been on the Boards of All.Can and PCE, where she was vice-chair.

Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the State Food and Drug Administration, and successively served as a clinical reviewer of anti-infective drugs, gynaecology, radiation, blood, and anti-tumor drugs.

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.

Cathelijne de Gram obtained her PharmD degree in 2000 from Groningen University, The Netherlands and since then she has been working in regulatory affairs both in the EU as well as USA. Cathelijne joined the global regulatory affairs department at Johnson & Johnson Innovative Medicine in 2012. Currently she is an EU regulatory policy leader in the Global Regulatory Policy and Intelligence department at Johnson & Johnson Innovative Medicine.

Michel is a regulatory strategist in the Lifesciences & healthcare sector with more than 20 years of regulatory, compliance and quality experience. Michel has led large scale, global regulatory transformation & remediation programs, operating model and process development, data integrity and technology programs in the area of quality & compliance.

Thomas joined Merck in 2000, exploring business value of novel technologies. He is co-founder of the Quantum Computing Interest Group, conference speaker, representing Merck in multiple quantum associations. His passion lies in tunneling resistance to address todays’ problems with playful curiosity.

Harald Enzmann is chairperson of EMA’s Committee for Medicinal Products for Human Use (CHMP). A physician by training, Harald held positions at the German Cancer Research Center (dkfz), at the Intitute of Pharmacology and Toxicology at the University of Erlangen, at R&D at Bayer and at the American Health Foundation in Valhalla, NY, USA. He received the dkfz award for outstanding research and the Animal Welfare Research Award of the German Ministry of Health. In 2002, Harald joined the Federal Institute for Drugs and Medical Devices (BfArM) and is currently head of European and International Affairs.

Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments, he deals with cooperation with state institutions and pharmacovigilance promotion. He is a member of the commission for human medicines and numerous task forces and working groups for regulatory affairs. Participates in the drafting of national legislation and guidelines for human medicines. Currently at ALIMS, he is the main leader of the digitalisation project of regulatory affairs for medicines.

Chris currently works as the MedDRA Safety Process Lead at GSK where his responsibilities include, oversight of the MedDRA upgrade, maintenance of all MedDRA linked tools as well as providing AdHoc coding support when required for the safety department. In his 17+ years in the PV industry he has worked in a wide range of roles in the pharmacovigilance space including case processing, PV agreement management, auditing, PV management and most recently PV safety system management (both ARISg and Argus). With a degree in Pharmacology his original intent was to work in drug research however it was his involvement in the PV Department at his first employer, used as a way to get to research, that changed his career path to this day.

Katja is Vice President in Epidemiology at Parexel’s Epidemiology & Real-World Science team. She has over 15 years of experience in RWE, epidemiology, and pharmacoepidemiology in a variety of therapeutic areas, such as neurology, oncology, and endocrinology. Katja has conducted and lead numerous RWE studies globally using a range of data sources, including national health and demographic registers, pregnancy and disease registers, claims, chart reviews, and prospectively collected data from sites. Numerous of Katja’s studies have had a regulatory demand, and have been submitted to regulators. Katja has MScPharm and PhD in public health and epidemiology, and is a registered pharmacist in Finland and Sweden. Katja is based in Sweden.

Based in Brussels, Matthias heads up Alexion’s EU Government Affairs and Strategic Alliance Development. Matthias is blessed to be working with the rare disease community as part of this role, particularly in therapy areas of Hematology, Nephrology, and Neurology. Against the backdrop of the revision of the EU pharmaceutical legislation, Matthias leverages his practical experience in funding negotiations across diverse EU markets, including AMNOG, as well as from leading engagement on framework conditions from a policy perspective at national and European levels. He regularly writes and speaks on life sciences topics.

Matthias Heyn holds the position of VP Language Technologies at RWS Trados and is a pioneer of language technologies focusing on multilingual processes and related technologies in a wide range of industries. Working across product engineering and business development positions from start-up to large scale organizations, he has focused on public-sector organizations in the EU and particularly in multilingual regulatory processes with a focus on the EU CP. Currently he is involved with combining translation technologies with AI and large language models (LLMs) in Cloud facilitated deployments.

Stéphanie Kromar joined the European Organisation For Research And Treatment Of Cancer (EORTC) in 2013. Since September 2022, she is the Head of the Regulatory Affairs department. She has experience in the preparation, submission, and follow-up of Clinical Trials Applications from the development until the end of the trial, on complex trial designs and she provides regulatory advice. She has an in-depth knowledge of the CT Regulation, was involved in the CTIS project almost since the beginning and she also took part to the review of the CTIS training material.

María Lamas is the Director of the Spanish Agency of Medicines and Medical Devices. PhD in Pharmacy from the University of Santiago, she is a specialist in hospital pharmacy and she is accredited as a clinical pharmacist in Oncology by the Board of Pharmaceutical Specialties (BPS) and the American Pharmaceutical Association (APhA). Before leading the AEMPS, she directed the Pharmacy Service of the Hospital of Santiago, while coordinating the Area of Platforms and Methodology of the Health Research Institute of Santiago (IDIS - ISCIII). In addition, she was the Research Director of the Spanish Society of Hospital Pharmacy from 2012 to 2016. She is currently coordinator of the Master of Pharmaceutical Oncology at the University of Valencia.

Nick has a PhD in physico-organic chemistry, and he started his career in Industry developing and implementing NIR applications in primary and secondary manufacturing. Since then, Nick has been involved in a number of organisations in different sectors (originator-generics-CRO; devices-combination products-medicinal), in increasingly senior roles, culminating as R&D Director for a small biotechnology company in Ireland. In his role at the HPRA, he has responsibility for assessment of many procedure types including CAPs, CTAs and EMA/national Scientific Advice. As well as being HPRA lead for Continuous Manufacturing and departmental lead for Drug-Device Combination products, Nick is currently ICH Q13 EC/Europe Topic Lead and vice-chair QWP

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.

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.

Klaudija is a physician with more than 20 years of experience in different pharmacovigilance fields. At present, she is Head of TPC – unit responsible for Company Core Safety Information, aggregate reports and risk management worldwide, supporting marketing authorizations and safety strategy for generics, biosimilar and innovative Teva products. Klaudija led in-house development of additional risk minimisation (ARM) implementation tracking tool and ARM digitalisation. Klaudija is Co-Chair of the Pharmacovigilance Working Group in Medicines for Europe.

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.

Henrik K. Nielsen has a background as M.Sc. Chemical Engineering, Ph.D. in Biochemistry and MBA. He joined Novo Nordisk in 1983 and has held several positions in Research, Product Development and Manufacturing in Denmark and the USA. Since 2004 he has served in several leadership positions in regulatory affairs and is currently Vice President for Global Regulatory Sciences. He represents Novo Nordisk as regulatory and biotechnology expert in a number of trade associations such as PhRMA, IFPMA and EFPIA where he is chair of the International Regulatory Expert Group.

Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive Dr Nolan was Director of Human Products Authorisation & Registration. Dr Nolan is a member of the Management Board of the European Medicines Agency (EMA) and as Chair of the Management Board of the EMA since March 2022.

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.

Caroline Pothet is head of the office for advanced therapies and haematological diseases at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug development, including 10 years in oncology; During these years, Caroline was privileged to be involved in the development and registration of several drugs (e.g. cervical cancer, melanoma, T-ALL/LBL). Caroline is also a member of the Regulatory Scientific Committee in the International Rare Disease Research Consortium.

Daniel is head of the Cross-Therapy area team in the Global Epidemiology Innovative Medicines department at Johnson and Johnson. In his current role, Daniel leads the strategy and manages teams of epidemiologists, analysts and project scientists; to develop and implement epidemiology studies on the benefit risk of medicines (incl. PASS). Daniel previously held various industry roles, working in infectious and rare diseases. Prior to his career in industry, Daniel worked for the Louisiana State public health department focused on the prevention of sexually transmitted diseases. Daniel is a member of Efpia and the lead representative to the ICH M14 EWG to develop guidance on the pharmacoepidemiology for safety assessment.

Yury Rozenman is the Senior Vice President of Business Development at Ada Health. In this role, he leads the company's strategy, vision and oversees execution of all global business development activities. Prior to joining Ada Health, Yury was SVP at ResMed driving digital and connected health business strategy. Prior to that Yury was the head of healthcare and life sciences industry partnerships at AWS where he was responsible for all HCLS partnerships. Yury has over 25 years of experience within pharmaceutical R&D both as a scientist and group research manager. In addition Yury led a variety of BD&L activities for Pharma, med tech and consumer device industries including Applied Biosystems/Celera, Pfizer, Qualcomm Life and Fitbit Health.

Dr Sarac has worked for more than a decade at the heart of medicines regulation in the EU. He is an experienced regulator, and an expert in regulatory decision-making, regulatory pathways, and clinical trial design. Dr Sarac served as member of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA), Committee for Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). He also chaired EMA’s Oncology Working Party (ONCWP). Dr Sarac has attended +100 plenary meetings in CHMP, CAT, and SAWP. His main expertise is in oncology/hematology. At Parexel, he is responsible for providing strategic regulatory advice to sponsors before and during major submissions to the FDA and EMA.

Rebecca Spencer works in the UK as an NIHR Clinical Lecturer in Obstetrics and Gynaecology and a Subspecialty Trainee in Maternal and Fetal Medicine. Rebecca is a founding member of the Maternal and Fetal Adverse Event Terminology (MFAET) Steering Committee with a research interest in translational obstetrics. MFAET provides the first adverse event severity grading criteria for maternal and fetal trials, developed through an International Delphi consensus process.

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.

Veronique Toully currently serves as Senior VP and Global Head of Sustainability, Corporate Affairs and Risks at UCB. She integrates sustainability and risk management into UCB’s strategy, championing positive impact for key stakeholders. With 30 years of experience in the healthcare industry, Veronique has honed her expertise in various roles including global market access and general management positions across Europe and Asia-Pacific. Veronique holds a Doctorate in Veterinary Medicine, an MBA from HEC Paris, and a Health Economics diploma from the University of York. She recently studied Sustainability Leadership at the University of Cambridge.

Atsushi is the Corporate Officer and Head of Therapeutic Area Strategy in Daiichi Sankyo, to manage multiple therapeutic area strategy. Prior to that, he was VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He has been global project manager for nearly 20 years (in JPN & US) and the head of PM office in Daiichi Sankyo Japan for 3 years. He has been an active volunteer to both DIA global and Japan, playing session chair roles in global annual meeting more than 10 times, and was the vice-chair for 13th DIA Japan Annual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.

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.

Veerle, diagnosed with Type 1 Diabetes in 1987, transitioned from event planning to a diabetes-related career, fueled by fundraising for Life For a Child. Since 2018, she's been a Communication Representative for INNODIA, a European consortium advancing T1D understanding and addressing tool deficiencies. Veerle is instrumental in both the INNODIA project and its non-profit arm, INNODIA iVZW, bridging therapy developers and tool providers. Additionally, she's a member of the PAC and INPACT, advocating for the T1D community.

Bert Verstappen is Manager Environmental Sustainability at Johnson&Johnson Innovative Medicine. Bert is a chemist and environmental scientist by education and has spent his professional life working on environmental sustainability topics in research institutes, consultancy and the industry. Advancing environmental health is key to our vision for a sustainable future because we know that healthy people need a healthy planet.

Siri Wang is Scientific Director at the Norwegian Medical Products Agency (NOMA). She is pharmacist by education and holds a PhD in pharmacology from University of Oslo. She has worked in hospital pharmacy for 15 years, mainly as counseling/clinical pharmacist, specifically involved in paediatric and geriatric medicine. Since 2007 Siri has been delegate to the Paediatric Committee (PDCO) at EMA. She was chair of PDCO’s Formulation Working Group from 2008 until 2013 and chair of CMDh/EMA Working Party on Paediatric Regulation from 2019 until 2023. Siri has been at NOMA full time since 2010 and has in her role a particular focus on paediatric medicines, covering the life cycle perspectives from development to actual access for children.

GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Big Data Steering Group and EMA Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics and is currently building regulatory AI/data science capacity and competence at the Swedish Medical Products Agency, exploring use of real-world data, and hoping for a better and data-driven world.

Obtained PhD in Biochemistry at University of Basel, Switzerland and Master of Science in Molecular Biology at University of Belgrade, Serbia. Broad experience in drug discovery and development and translational safety assessment strategies. After a postdoc in mouse genetics research, joined Preclinical Safety Department in Novartis Pharma, Basel, Switzerland, where she held various roles of increasing responsibilities. Current role: Immunology Therapeutic Area Head, responsible for non-clinical safety programs of Novartis Immunology portfolio across modalities.

Reem Eaid Alnaimat, head of manufacturing site accreditation at Jordan Food and Drug Administration, is a regulatory affairs consultant with a Master's in Pharmaceutical Science and an MBA. With over 14 years of experience, she represents JFDA nationally and internationally at conferences on regulatory topics. Reem leads the Generics Evaluation and JFDA Manufacturing Site Accreditation committees and participates in various others. Previously, she served as a regulatory affairs consultant in Qatar and head of the pharmacy department at Eman Hospital in Jordan's Ministry of Health.

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.

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.

Manuela Braun, PhD, Senior DMPK Project Leader/Gene Therapy Expert, Bayer AG Senior scientific expert with 24 years of preclinical and clinical experience in all phases of global drug development with a particular focus on biologics, RNA modalities, gene and cell therapies. In-depth knowledge of DMPK and bioanalytics of various drug classes. Contributing expert in various global gene therapy consortia (EFPIA, ARDAT, IQ Consortium, AAPS, SCB) working to harmonize gene therapy development. Leader of expert groups from industry and science that aim to standardize anti-AAV antibody tests and harmonize validation requirements in exchange with authorities (ARDAT, IQ consortium). Deputy EFPIA representative in the ICH S12 expert working group.

Mrs Hélène Bruguera graduated in Biochemistry from the University of Nancy and has a Master in Industrial Pharmacy from the University of Strasbourg. She worked for the pharmaceutical industry for 10 years in analytical development and in the preparation of the quality part for marketing applications. She joined the EDQM in year 2000, and is currently the Head of the Certification Department. She deals with the management of CEP applications as well as the EDQM inspection programme for API manufacturers. She is also involved in international platforms related to the quality of medicines and active pharmaceutical ingredients (ICH, IPRP), and is currently co-chair of the IPRP Quality Working Group for Generics (QWGG).

Sinead Curran is a member of the HPRAs Leadership team. She is Director of the Human Products Monitoring department, with responsibility for safety monitoring and risk management of medicines in clinical use. She has worked in medicines regulation for over 20 years, in the areas of clinical development, pharmacovigilance, quality assurance & compliance, and patient public engagement. She holds a Bachelor of Science (Hons) degree from the National University of Ireland Galway and a Master Science in Pharmaceutical Medicine from Trinity College Dublin.

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments, acquired scientific and regulatory expertise, communication, education and presentation skills, as well as a thorough understanding of project and budget management. She is an active member of the International Society for Pharmacoepidemiology with previous roles as Board member, VP Finance, and various committees. She is visiting professor of pharmacoepidemiology at the University of Bath in the UK.

Dr. Dias, Head of Supply and Availability at EMA since 2021, leads key initiatives including co-chairing the HMA/EMA Task Force and chairing the Medicine Shortages SPOC Working Party. With a pharmacy degree from Lisbon and a PhD from Cardiff, she joined EMA in 2004, specialising in quality for 10 years before leading policy and crisis coordination. Dr. Dias now oversees EMA's extended mandate on shortages under Regulation (EU) 2022/123.

Sheila has an in-depth understanding of the topic of patient preferences through several leadership roles and key contributions to the 5.5-year IMI PREFER project which addressed the question of why, when and how to assess and use patient preferences in medical product decision-making. She has been instrumental in developing the PREFER framework for patient preference studies as industry lead. In addition, Sheila has deep expertise in structured benefit-risk and was recognized with a Novartis Leading Scientist Award for her work in this area. She spearheaded the implementation of structured benefit-risk at Novartis to address regulatory expectations and to ensure alignment with the ICHM4E(R2) guidance.

Sebastian is Regulatory Strategist at TÜV SÜD in Munich. Before joining the notified body, he spent eight years as Regulatory Intelligence and Policy expert in pharmaceutical industry at Merck KGaA, Darmstadt. He is Biomedical Scientist by training (M.Sc.) and holds a master’s degree in Drug Regulatory Affairs. His key interests are regulation of combination products as well as digital medical devices and Artificial Intelligence.

Valentina is a Senior Clinical Trial Regulatory Lead at Roche and has over 15 years’ experience in regulatory and clinical trial development. As a process owner she is providing critical expertise to the End-to-End Clinical Trial Application (CTA) process to ensure compliance and is also contributing to cross-functional initiatives, industry forums and health-authority interactions. Valentina is the Clinical Trial Regulation (CTR) process lead and together with a cross functional team of experts, has developed and implemented new procedures and supporting solutions, including automation-driven solutions to support the successful implementation of the EU CTR at Roche.

Yves Jacob, Head of Europe Region, Global Regulatory Affairs, Sanofi, offers strategic regulatory expertise to European Countries. Representing Sanofi to EMA and external stakeholders, he ensures alignment. With 20+ years in regulatory affairs, Yves led teams securing initial drug approvals in cardiology and diabetes. Previously, he directed R&D projects for anticholesterol drugs. Based in Paris, Yves assumed his current role in July 2023 after 3 years as France's regulatory head. Pharmacist background with experience in retail pharmacy and hospitals.

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.

Dominik Karres has a medical degree and a MD in paediatric drug development. He held a training post in paediatric haematology/ oncology, last working in the UK as clinical fellow in paediatric oncology drug development. He works in drug regulation since over 10 years, with various roles at the MHRA, currently at EMA as Senior Scientific Specialist in the Paediatric Medicines Office and most recently also supporting technical regulatory/ HTA collaboration across the agency as HTA/ payer engagement specialist.

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.

Zili oversees all R&D activities within Asia Pacific, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region. Zili joined Janssen in June 2019 from the FDA where he served as Associate Director for Global Affairs at the Office of Generic Drugs. There he contributed significantly to the expansion of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to the field of generic drugs, playing a critical role in China’s National Medical Products Administration’s membership in ICH in 2017. Zili is a graduate of Peking Union Medical College and completed his residency training at Johns Hopkins in 2000.

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support the acceptance of real-world evidence for regulatory decision making in oncology. Nicole developed and advanced anti-infectives policies as a Director of Global Regulatory Policy at Merck, senior officer for the Pew Charitable Trusts' antibiotics and innovation project, and FDA Commissioner’s Fellow. She earned a doctorate in biochemistry from the Albert Einstein College of Medicine and was a postdoctoral fellow at the University of California, San Francisco.

Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.

Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative issues that impact R&D. She is driving the regulatory policy advocacy agenda through participation in critical US and EU-based trades and coalitions. Before joining Merck, Christine headed Regulatory Affairs at the German Association of Pharmaceutical Industry, driving development of industry positions on new regulations for 8 years. Prior to that she worked at Allergan. She also was visiting professor for RA Master studies at Uni Bonn for 17 years.

Lamine (Amine) Messaoudi, D.V.M., is the Head of Regulatory Policy and Innovation for EUCAN at Takeda, focusing on evaluating and influencing new regulatory policies. With over 24 years of experience in global regulatory sciences, he has worked for leading pharmaceutical companies, contributing significantly to the development of drugs for autoimmune disorders, gene and cell therapies (ATMPs) and infectious diseases (HIV, HCV and HBV).

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).

Mariska has over 21 years of experience in Regulatory Affairs, spanning global and regional positions. Her expertise covers all drug development stages and life cycle management across diverse therapeutic areas, including Rare Diseases, Immunology & Inflammation, Neurology, and Oncology. She joined Ultragenyx in Nov 2022 as Head of Regulatory Affairs for EMEA, later expanding her role to include LATAM and global oversight for marketed products in Oct 2023. Previously, Mariska held leadership roles at Sanofi, Novartis Vaccines & Diagnostics (now part of GSK vaccines), Crucell (now part of Janssen Vaccines), and Solvay Pharmaceuticals (now part of Abbott), focusing on different therapeutic areas and global business units.

Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements & licensing of pharmaceuticals. He has also worked in the field of competition law with the EC & in the pharma industry. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

Raluca is a pharmacist and has 10 years of pharmacovigilance experience in the pharmaceutical industry, from early to late phase clinical trials with novel therapeutic agents, across therapeutic areas in oncology and non-oncology, both in adult and pediatric patients. In her current role she is developing the global safety strategy for immunotherapies, including safety risk management and minimization strategies for products during clinical trials and also for marketing authorisation applications, including RMP and aRMM development, and REMS development.

Dr Jean Pierre Nyemazi works at the World Health Organization (WHO), where he coordinates a Quadripartite Joint Secretariat team focusing on multisectoral activities against AMR, including the development of integrated surveillance systems for AMR/AMU, estimating the burden and economic impact of AMR and supporting the Global Governance Structures. Before joining WHO, he was the Permanent Secretary of the Ministry of Health of Rwanda.

Pharmacist with a Master degree in Pharmacovigilance, working experience at EMA in the Compliance and Inspection department, since 2016 working on the development CTIS and leading on CTIS transparency aspects, EMA liaison at the Clinical Trials Coordination Group (CTCG) and from October 2023 Programme Manager for the ACT EU initiative.

Kelly is the Director General of Health Canada’s Marketed Health Products Directorate. She leads a diverse team on a range of health product regulatory activities including surveillance, assessment, and risk management; risk communications; health product advertising; use of real-world data/evidence; administration of drug related intellectual property regimes; and domestic and international stakeholder engagement. She has worked to align reviews between Health Canada and Health Technology Assessment organizations, in establishing and advancing collaboration with foreign regulatory authorities through various platforms such as Access and ORBIS, and co-chairing the ICMRA Working Group on Real-World Evidence for Public Health Emergencies.

Paul-Etienne Schaeffer worked as Global Regulatory Science & Policy Associate within Sanofi in France. His tasks were focused on regulatory aspects regarding electronic Product Information, big data, artificial intelligence, digital therapeutics, apps and wearables. He has been working since October 2019 as Life Sciences Regulatory Affairs Manager at AESGP (Brussels), where he is involved in digital, medicines and medical devices topic. He has been a member of the Inter-Association task force on electronic Product Information steering group since 2019 and actively participated to the recent Pharma Law review discussions.

Dr. Scheeren worked in R&D in the Pharmaceutical Industry for over 35 years in the USA, China and Europe. Former Chair of DIA. Currently , he is a Board Member of VacciTech plc. He recently founded a consultancy company ScheerenHeathCare LLC. Since January 2019, he is Adjunct Professor at Peking University for Regulatory Sciences. He was President and CEO of the C-Path Institute from 19-21. Dr. Scheeren serves on the Forum of the NAS, on Advisory Boards at the CIRS, the Regulatory Affairs Track at Yale University, the CoRE in Singapore, the College of Pharmacy at the UA. He is also a foreign member of the Academie Nationale de Pharmacie in France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

Hamada Sherief is the General Director for Human Pharmaceutical Drugs Registration at the EDA. He’s responsible for authorizing new registrations and re-registrations of human pharmaceutical drugs. His career began as a Quality Control Analyst at NODCAR & research after graduating with honors from Cairo University’s Pharmacy Faculty. In 2010, he transitioned to a Registration Specialist role at NODCAR. With the establishment of EDA in 2020, he became the General Manager for Technical Support in Quality Control Labs. His dedication and expertise led to his promotion to his current role in June 2022. He has consistently demonstrated excellence in his field, contributing significantly to the pharmaceutical industry.

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.

Since 2009, Biljana has served at Bosnia and Herzegovina's Agency for Medicinal Products and Medical Devices, currently as Deputy Director overseeing human medicinal products. Her role spans marketing authorization, policy drafting, EU regulatory alignment, price regulation, product information dissemination, shortage monitoring, and advertising oversight. Additionally, she's an external expert for CEP issuance and serves as the IPA project contact with the European Medicines Agency since 2018. Biljana, a pharmacist and Medicinal Chemistry professor, brings extensive expertise to her multifaceted role.

Serhat Aladag, who has a master degree in Biomedical Engineering and continues his PhD in Bioengineering, works as a Quality Manager at the National Control Laboratories affiliated to Turkish Medicines and Medical Devices Agency (TMMDA). He has carried out works on regulatory system strengthening, legislative harmonization and implementation of various quality management system standards. He has over ten years experience in clinical engineering, bioengineering, test and calibration services, laboratory quality management systems and international collaborations.

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.

Mr. Babiker has more than 25 years of experience in different fields of pharmacy practice including hospital, community and clinical pharmacy, drug information, patient safety, quality and risk management. By training, he is a pharmacist with an additional Master program from Queens University Belfast in the UK. His research interests are in the areas of patient safety and pharmacy practice. Mr. Babiker has worked as drug information pharmacist at Hamad Medical Corporation, the principal health institute in Qatar. Through his work for the Ministry of Public Health, especially the Community Pharmacies Steering Group and as vaccine registration supervisor, he also has experience with the development of policies.

Dr Kate Bendall leads the Implementation team at Axian Consulting. Her remit is to ensure that Axian’s approaches and software systems are designed and implemented to meet the needs of stakeholders in local markets across the globe. Kate draws on her longstanding experience in project and programme management from supporting clients in the pharmaceutical industry, plus experience from her role of Head of Operations at Pope Woodhead. Before this, Kate worked for over ten years leading programmes of client work as Principal Consultant for Oakland Innovation. Kate has also worked as a medical writer for Qiagen GmbH and holds a D.Phil in Genetics from Oxford University.

Jan Bertels is chief of cabinet of the Belgian Deputy Prime Minister and Minister of Social Affairs and Public Health, Frank Vandenbroucke. He is a lawyer by training. Prior to becoming chief of cabinet, he has been an active politician as Member of Parliament and Mayor of the town of Herentals. He was Director General in the federal administration social security for more than ten years.

Laurence Brihaye has +20 years of Labelling and Regulatory Affairs experience. Since the beginning of her career at Bristol-Myers Squibb, in addition to her European regulatory procedural expertise, she managed all the EU labelling activities (from PIM to ePI, from translation management to packaging development). She was the Business Lead for the PI translation outsourcing project and actively contributed to the End-to-End labelling transformation of the company. For a few years she has also been a member of the EFPIA's ERAO PI content group and of the IATF Content, Readability, Layout group.

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.

Irina Cleemput is Scientific Programme director at the Belgian Health Care Knowledge Centre (KCE). She graduated as PhD in Health Economics at the KULeuven in 2003. On behalf of KCE, Irina co-led the work package on recommendations and chairs the stakeholder advisory group for HTA bodies and payers in PREFER, an international study about incorporating patient preferences in the medical product development life cycle. Currently she leads the NEED project (Needs Examination, Evaluation and Dissemination), an initiative of KCE and Sciensano to identify and assess unmet patient and societal needs in healthcare, in order to move from supply-driven to more needs-driven innovation and policy in healthcare.

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.

Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

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.

Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories, Food Registration, and GMP Inspection. He started his career at Anvisa in 2007 as an Inspector of Good Manufacturing Practices. Aquino holds a Bachelor's degree in Pharmacy and Biochemistry and a Master's degree in Pharmaceutical Sciences from the University of São Paulo. He also has specializations in Health Surveillance from the Oswaldo Cruz Foundation and in Micropolitics of Management and Work in Health from the Federal University of Fluminense.

Björn Eriksson, Director General of the Swedish Medical Products Agency (MPA) since 2021, previously a board member since 2018. Holds a medical degree and PhD in Cardiology from Karolinska Institute. Experience spans clinical and research roles at Karolinska University Hospital and pharmaceutical industry. Managed clinical departments in Östersund and at Akademiska University Hospital, Uppsala. Served as Regional County Director for Region Jämtland-Härjedalen, Hospital Director for Skåne University Hospital, Lund and Malmö. During the SARS Covid-19 pandemic, acted as Health Care Director in Stockholm. Within the EU regulatory network, serves on the EMA Management Board as member and in the HMA Management Groupas as chair.

Segolene Gaillard, Clinical Project Manager and methodology advisor in Pediatrics and rare diseases, collaborates closely with pediatricians in Lyon hospitals. She develops methodologies and protocols for academic and industry projects and serves as a methodology expert on a French ethics committee. Coordinating the RIPPS network and contributing to EnprEMA, she leads Kids France, promoting young people's involvement in pediatric clinical research. Her PhD focuses on youth participation in research, evaluating the impact of Young Persons Advisory Groups (YPAGs). Since 2021, she coordinates a regional rare diseases network in Auvergne-Rhône-Alpes, enhancing healthcare and research expertise visibility.

Michiel Hendrix is working as project lead and policy advisor at EMA’s International Affairs department. In his current role he is project coordinator for EMA’s support programme to EU candidate countries and potential candidates and member of the team implementing EMA’s support action to the establishment of the African Medicines Agency. Michiel has over 15 years of experience in policy-making in international affairs for a range of public organizations - a substantial part of which he spent contributing to the European Medicines Regulatory Network.

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.

Christine is a passionate global regulatory affairs leader with a background in biological sciences and over 15 years of experience in pharmaceutical research and development. Christine has worked across both clinical and nonclinical programs, with a focus on regulatory affairs strategy. Throughout her career, Christine has supported the global development of multiple medicinal products in the therapeutic areas of neurology, pulmonology, and gastroenterology, with compounds in all phases of development. Currently, she is supporting the regulatory affairs strategy for products in paediatric and rare disease patient populations within the therapeutic area of neurology.

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.

Rogier is Associate Director Data Science at Pfizer. He is passionate about using machine learning to build tools for medicine and living a healthy life. He has experience developing machine learning solutions involving natural language processing, generative AI, genomics and proteomics, computer vision and voice analysis. At Pfizer he has worked on anomaly detection in clinical trial data, detection of Covid based on voice, prediction of medication response using multi-omics, and automated generation of regulatory documents. Prior to Pfizer, he worked as a neuroscientist at NIMH, MIT and the Broad Institute, and in data science consulting. He has a PhD in Neuroscience from University of Amsterdam, Netherlands.

Sylvie has been engaged in regulatory policy activities for 20 years, through positions in Brussels trade associations, including EFPIA. She joined MSD as Director Global Regulatory Policy in June 2015, where she is now Global CMC Policy Director. Sylvie’s expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. Sylvie also co-leads the IFPMA Manufacturing & Quality Group policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II and a Diploma from the University of Kent at Canterbury.

Estelle Michael majored in science and law, and is a recognized global industry policy leader who aims to positively impact people’s lives and to develop sustainable ecosystems, that facilitates patient access to health care solutions. She has partnered with DIA for over twenty years and in collaboration with patient groups, policy makers, academia and industry delivered thought provoking and forward looking panel discussions and workshops. She strives for excellence as a leader, and strongly believes that we need to continuously learn and improve, failing fast and succeeding slow and long

Background in clinical medicine and lecturing in clinical trial methodology. Working in the Medical Devices department of the Irish competent authority (HPRA), focusing on clinical investigations and performance studies of medical devices and in vitro diagnostics. Sits on the Clinical Investigation and Evaluation Working Group of the Medical Devices Coordination Group at a European level

10+ years of Leadership and Management expertise at senior or very senior level in three separate Regulatory Authorities (MHRA – Medicines and Healthcare products Regulatory Agency, UK; Danish Medicines Agency, Denmark; PEI – Paul-Ehrlich-Institut, Germany). Memberships in Committees/Working Parties at the European Medicines Agency (EMA)

Julie Spony is Policy Officer at the European Patients' Forum (EPF), the voice of patient organisations in Europe. In this role, she contributes to EPF's policy and advocacy work, including leading EPF's activities on the revision of EU pharmaceutical legislation. Julie has a multidisciplinary background in Law, Economics and Political Science and holds a Master's degree in European Affairs from Sciences Po Lyon (France). Prior to joining EPF, Julie worked at the European Commission and the European Parliament, focusing on rule of law and human rights.

Dr. Leda Stott specializes in partnership projects. With 25 years of experience, she's engaged with intergovernmental bodies like the European Commission, United Nations, and World Bank. A seasoned expert, Dr. Stott collaborates with public agencies, foundations, businesses, and NGOs. Holding a PhD on the topic of partnership from the University of Edinburgh, she has imparted knowledge on the subject in postgraduate programs in the UK, Spain, Norway, and South Africa. She serves as a partnership expert for the European Community of Practice on Partnership (ECoPP) and is an Associate of the Partnership Brokers Association and the Innovation and Technology for Development Centre at the Technical University of Madrid (itdUPM).

Dr. Pamela Tenaerts, currently serving as Medable's Chief Scientific Officer, is a respected advocate for clinical trial innovation. At Duke University, she previously led the Clinical Trials Transformation Initiative, improving efficiency and the quality of trials. With over three decades in conducting and researching clinical trials, her focus on patient engagement and evidence-based approaches has been notable. A board member at MedStar Research Institute, and an active member of the Drug Forum of the National Academies of Science, she holds an MD from the Catholic University of Leuven and an MBA from the University of South Florida.

Ioana Ulea, FDA Europe Office policy advisor since Oct 2023, analyzes EU medical product policies, enhancing FDA's engagement with European counterparts, promoting regulatory alignment. Before assuming this role, Ioana worked for over nine years in the medical device regulatory affairs sector, her expertise covering pre-market submissions, clinical trials, and vigilance. She holds a law degree from the University of Bucharest and an Advanced Master's from Université Libre de Bruxelles.

Hilde is a passionate industry leader with +29 years expertise in various drug development domains. She has a track record of turning large and complex programs into realization through collaboration, such as J&J’s Integrated Smart Trial & Engagement program, J&J Expanded Access Programs and Transcelerate eConsent Project. Partnership is part of Hilde’s DNA. Hilde is currently heading up the non-profit multistakeholder European Forum GCP (EFGCP) eConsent initiative, next to her role as Head TCS Industry leaders Life Sciences. Hilde is a PhD in Medical Sciences, Engineer in Microbiology, and Master in Environmental Sciences, all obtained from the University of Leuven in Belgium.

Katia Verhamme is Associate Professor of Use and Analysis of observational data. Within the department of medical informatics, she is leading the pharmacoepidemiology group and is an expert on multi-database studies. Katia graduated as medical doctor from the University of Ghent and trained as General Practitioner. Since her PhD graduation as pharmaco-epidemiologist from the Erasmus University Medical Centre, Katia has successfully developed a research group conducting pharmaco-epidemiological research, using electronic patient records as compiled in various observational health care databases. Katia is Study Operations Pillar Lead of the Darwin EU® Coordination Centre.

Zainab Aziz is a registered pharmacist in South Africa and holds a Masters in Pharmaceutical Affairs. She has been working in the pharmaceutical field for over 18 years, within hospital, retail, managed health care and industry settings. She has extensive experience in the Regulatory Affairs environment across various regulatory landscapes. Zainab is currently working at Novartis as an Associate Director in the Regulatory Affairs Policy and Strategic Operations team for Sub-Saharan Africa. She also serves as co-chair of the IFPMA Africa Regulatory Network, where she has been involved in several key projects covering regulatory harmonisation, clinical trials, regulatory capability building, biosimilars and quality related matters.

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.

I am a researcher, studying how health care organisations, professionals and patients handle uncertainty and complexity. In particular I am study how organisations and individuals work with risk and uncertainty, and how trust and hope shape this relationship. I have worked at the University of Amsterdam since 2010 where I am an associate professor and research programme leader within the Amsterdam Institute of Social Science Research. Among other professional roles, I am Editor of the journal Health, Risk and Society and am Chair of the research network on the Sociology of Risk and Uncertainty within the European Sociological Association.

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.

Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts for global implementation of the ISO standard for Medicinal Product Information (IDMP) such as ISO TC 215 WG6 and co-chair the Global IDMP Working Group (GIDWG). She has a master’s in Molecular Biotechnology Engineering and a PhD in Medical Biophysics from Karolinska Institute, Sweden.

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.

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.

Mario Jendrossek serves as the European Projects Lead at the French Health Data Hub (HDH), with previous experience in health research, health policy, within international organizations, public administrations, civil society, and the private sector. In his current role, he spearheads partnership development with European entities, monitors European legislative developments on health data including EHDS regulation, and manages HDH's involvement in EU-funded projects. Most notably, Mario oversees HDH's work on the HD@EU pilot project, coordinating efforts to establish a cross-border health data infrastructure in line with EHDS regulation.

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.

Laurence is a qualified pharmacist. He joined the Health Products Regulatory Authority in 2004 and worked as a quality assessor for almost 12 years before being appointed to his current role of Scientific Affairs Manager in April 2016. Laurence is actively involved in the implementation of a number of initiatives related to the HPRA’s strategic goal to support health product innovation, including the HPRA’s Innovation Office. He is also co-chair of the EU Innovation Network (EU-IN), which has a joint mandate from the European Medicines Agency and the Heads of Medicines Agencies.The EU-IN brings together representatives from innovation offices across the EU medicines regulatory network to facilitate the development of innovative medicines.

Dr. Isabelle Stoeckert has spent 30 years in various leading positions in Regulatory Affairs in the pharmaceutical industry. Until 11/2024 she served as Vice President Regulatory Affairs EMEA at Bayer AG. Prior to that she gained global experience as Head of Global Strategy Pharma and Head of Regulatory Affairs International. She gained her Regulatory Science expertise from Public Private Partnerships and as member of several EFPIA teams in regular dialogue with Regulatory Agencies. Isabelle supported the preparedness of Bayer for the HTA Regulation as a member of the EU HTA Task force and has contributed to the policy discussion on the practical implementation of the Regulation at the interface between Regulators, HTAs and HT developers.

Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also the introduction of AI and Machine Learning methodologies in these areas. Recently, he represented EFPIA and Roche in EMA Quality Innovation Group sessions, participated in FDA workshops on innovative manufacturing approaches, and presented at the DIA Europe 2024 Diamond Session on Innovation in Manufacturing in Brussels.

Milana Trucl is a Policy Officer at the European Patients’ Forum, where she develops and guides the policy and advocacy work in the area of digital health and chairs EPF’s Digital Health Working Group. Her goal is to ensure that the patient perspective is integrated into EU policies, initiatives and projects on digital health and artificial intelligence in healthcare, and to shed light on the importance of patient engagement, health literacy and equitable access to digital services and solutions.

Gerard van Westen is a full professor in the Division of Drug Discovery and Safety at the Leiden Academic Centre for Drug Research. He is a member of the interdisciplinary research programme Society, Artificial Intelligence and Life Sciences (SAILS). His main area of research is leveraging artificial intelligence with diverse and large-scale public data (‘big data’) for precision medicine.

Wendy is a pharmacist by training, having graduated from Beijing Traditional Chinese Medicine University (China) and received an MBA from Staffordshire University (UK). She began her career in Beijing Drug Control Institute which is subordinate organization of China NMPA in 1988. Since 1996, she had held multiple leading Regulatory Affairs positions at several multinational pharmaceutical companies including Bayer, GlaxoSmithKline, AstraZeneca for 18 years. Wendy joined BeiGene as the Senior Vice President, Global Head of Regulatory Affairs in 2014 and was appointed as Senior Vice President, Chief Regulatory Officer since 2021. Wendy is DIA board members as observer.

After graduating in Political Science and International Relations at the University of Bologna, she started her career as a journalist reporting on EU social policies and policies on disability in Brussels. She completed an Advanced Master's in European Studies at the UCLouvain Saint-Louis University in Brussels and a Master's in International Patient Advocacy Management at the Cattolica University in Rome. She has been working at the European Liver Patients’ Association since 2019, focusing primarily on patient engagement in a multistakeholder environment at the national and international levels. She is currently the head of the ELPA Brussels office.

Member of the Board of Directors of EURORDIS – Rare Diseases Europe. CEO of a patient organization called Foundation of Borys the Hero focused on strategic advisory for public entities. Member representing patients' organizations nominated by the European Commission to the Paediatric Committee of the European Medicines Agency (EMA PDCO). Patient Advocate involved as an e-PAG Member of ERN-ITHACA and Patient Board Member of MetabERN. Cooperates closely with the Rare Disease Centre of Medical University in Gdansk. He is a father of a child living with rare neurological disease called metachromatic leukodystrophy.

Saima Khakwani is a Clinical Science Associate at Clario. Her focus in the team includes diary design best practice such as impact of use of paper and free text in eCOA, patient safety and minimizing risks for commonly implemented PROs and ClinROs and building databases. In her current role, Saima analyzes how our approach to implementing PROs and ClinROs can be tailored to decrease patient burden and increase patient engagement across various therapeutic areas and indications, and builds knowledge databases. She continues to work on research for improving quality of clinical trial delivery and has authored and co-authored numerous works and publications as a result.

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, Office Director, and Deputy Super Office Director of Science. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance, and policy.

Maya Matthews is the Head of Unit for State of Health in the EU at the European Commission's DG SANTE. She joined in 2008 and previously worked at the EU's Delegation to the UN in Geneva. Maya has experience in health issues, consulting on reproductive health, HIV prevention, and Tuberculosis. She holds a BA in Human Sciences from Oxford University and a Masters in Health Promotion Sciences from the London School of Hygiene and Tropical Medicine, where she also conducted research from 1993-1995.

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.

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.

Robert Sauermann, MD, is consultant in internal medicine and clinical pharmacologist. From 2002-2012 he worked as physician, researcher and associate professor in Clinical Pharmacology at the Medical University of Vienna, Department of Clinical Pharmacology. Since 2012 he works at the Austrian Federation of Social Insurances, where is deputy head of the Department of Pharmaceutical Affairs. The department’s main responsbilities include drug evaluations (comparative assessment of benefit, economic assessment) and pricing for reimbursement decisions in the outpatient sector in Austria.

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.

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. She was the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC) from 2012 till 2018 and acted as PRAC chair from July 2018 till July 2024. She also holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

Chemical Engineer & Executive MBA, officially certified in Safety & Industrial Hygiene and proficient in Environment, Risk and Sustainability. Passionate by protecting people & planet, leveraging my operational & corporate experience acquired from exposure to culture diversity, international and global teams. Driving the change on the front line and developing people during this journey from vision & strategy to successful implementation with passion and positivism leadership. Sectors: Biopharma, chemical, glass, mining.

Jeevan Virk is Therapeutic Area Strategy Head for Radioligand Therapy (RLT) at Novartis. He has previously been involved in commercial and general management roles at Novartis. His background is in biotech, working with Advanced Accelerator Applications, the first company to gain regulatory approval for an RLT with FDA and EMA. Advanced Accelerator Applications was based in Europe and acquired by Novartis in 2018 for $3.9b.

Christine Dehn joined the German Heart Foundation more than 20 years ago. As a patient representative she strongly advocates for patient needs, concerns and thoughts in national, as well as international contexts. She currently is the EHN member in the Patient and Consumer Working Party (PCWP), established by the EMA, where she represents the CVD patient view. Her mission within the German Heart Foundation is to ensure that the patient’s voice is heard whenever it’s about the patient – be it in political discussions, research projects or clinical settings.

Lisa Ensign is a VP of Statistics and Regulatory Science Innovation at Medidata. Her recent work is focused on creating robust analytical approaches to improve and transform the efficiency and rigor of clinical trials, centered on the use of external controls in areas of unmet medical need. Lisa began her career at MD Anderson Cancer Center and has extensive academic, industry. regulatory and entrepreneurial experience in the life sciences sector. She received her MS in biostatistics from Harvard University and her PhD in clinical science from the University of Colorado, where she teaches graduate courses on ethics and the responsible conduct of research.

Roberto studied Pharmacy in Hamburg from 1983 to 1988 and obtained his PhD in 1993. After working as a hospital pharmacist in Lübeck and Cologne, he was from 2001 to 2017 Director of Pharmacy, Qualified Person and lecturer on Pharmacoepidemiology at the University Hospital of Leipzig as well as Director for Patient Care at the Centre for Patient Safety. From 2015 to 2017 he was a board member and from 2009 to 2015 the president of the European Association of Hospital Pharmacists (EAHP). He is member of PRAC at EMA.

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.

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

Carolyn Hynes is a Senior Director leading the regulatory intelligence team in Oncology Regulatory Science, Strategy & Excellence at AstraZeneca. She has more than 20 years of experience working in large pharmaceutical companies in regulatory intelligence and policy roles. Carolyn holds a PhD in cardiovascular pharmacology from Queen Mary College, University of London.

Nathalie Moll is Director General at the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA represents the pharmaceutical industry operating in Europe. Together with its direct membership 40 leading pharmaceutical companies, 33 national associations representing over 1,900 companies and in collaboration with health and research players, EFPIA's mission is to create an environment that enables members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.

Ruby earned his bachelor's, master's, and Ph.D. in Applied Mathematics studying nonlinear waves in physics (the field of Integrable Systems and Soliton Theory) at the University of Arizona. Afterwards, he became a Postdoctoral Fellow in Digital and Precision Medicine in September 2022 and later a Quantitative Medicine Scientist in June 2023, both at the Critical Path Institute, a neutral precompetitive space facilitating interactions between industry and regulatory agencies with the aim of improving the drug development pipeline. Ruby supports the Critical Path for Parkinson's consortium by developing feature extraction and analysis pipelines from Digital Health Technology-based data.

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

Rémi Savage is a Senior ESG analyst at Candriam, a leading global sustainable investment company, focused on responsible investment across a range of traditional and alternative asset classes. Since joining Candriam in 2018, Rémi plays a key role in the development and follow-up of sustainable Healthcare investments within Candriam. Besides his role as the Lead ESG analyst covering the Healthcare and Real Estate sectors, Rémi coordinates the Social analysis across the ESG model. Rémi came from AXA IM which he joined in 2014 after starting his career as a trainee in ESG equity research at Natixis CIB. Rémi holds a master’s degree in economics and finance and a master’s in international relations, from Sciences Po Bordeaux, France.

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.

Günter Waxenecker, with a Master's in drug regulatory affairs, boasts 20+ years in drug development. Recognized for innovation and efficiency, he leads the Austrian Medicines and Medical Devices Agency since 2023, following key roles at Vienna SMEs and the Austrian Federal Office for Safety in Health Care. His expertise spans interdisciplinary know-how, cross-functional collaboration, change management, and international experience. As a lecturer at FH Campus Tulln, FH Joanneum Graz, and Vetmed Vienna, he shares his wealth of knowledge.

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.

James Ryan is an experienced health economist with over 25 years of experience in both medical devices and medicine HTA, working across academia and consultancy, as well as country and global industry roles. Currently Director for Global HTA Policy, HTA and Modelling Science at AstraZeneca, James blends his passion for policy, and evidence, leading a team of HTA experts delivering global payer evidence for HTA bodies for AstraZeneca’s oncology portfolio. He represents AstraZeneca at the HTAi Global Policy Forum, as well as at European Federation of Pharmaceutical Industries and Associations (EFPIA) HTA Working Group, where he co-leads the methodology workstream as the biopharmaceutical industry prepares for the EU HTA Regulation.