Meet Us at DIA Europe 2022

Speakers

• 

  Virginia Acha, PhD, MSc

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

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

• 

  Christelle Anquez-Traxler, PharmD

  • Regulatory and Scientific Affairs Manager
  • AESGP, Belgium

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

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  Sabine Atzor, MPharm, RPh

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

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

• 

  Simon Bennett, MSc

  • Director, EU Regulatory Policy
  • Biogen, United Kingdom

  As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly senior roles across regulatory product development and lifecycle management. He has been working in regulatory policy since early 2016. Prior to joining Biogen, Simon worked in medical communications in different therapeutic areas. He is a biologist by training with an MSc in medical parasitology.

• 

  Kristin Bullok, PhD

  • Benefit-Risk Management Scientist, Global Patient Safety
  • Eli Lilly and Company, United States

  Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies, and developing regulatory scientific communications. She is lead for the scientific dissemination strategy as part of the communications team for PREFER and developing the PREFER framework for preference studies.

• 

  Melanie Carr

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

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

• 

  Alison Cave, PhD

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

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

• 

  Magda Chlebus, MA

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

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

• 

  Gracy G Crane, PhD, MS

  • Policy Lead
  • Roche, United Kingdom

  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.

• 

  Maria Dutarte, MA

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

• 

  Falk Ehmann, MD, PhD, MS

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

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

• 

  Dagmar Goertz

  • Director GCP Risk Management Lead
  • Pfizer Pharma Gmbh, Germany

  Dagmar holds the role of Director Organizational Excellence in BioResearch Quality & Compliance (BRQC) at Johnson & Johnson. She joined the healthcare industry in 1988 and gained several years of experience in pre-clinical/clinical research at Grünenthal. Before she joined Pfizer in 1998, she worked as CRA at Boehringer Ingelheim Ltd. Ireland. At Pfizer she held positions with increasing responsibilities in Clinical Project & Quality Management, GCP/ PV Inspection Management and as Regulatory Intelligence Lead. She was responsible for Regional Quality Oversight for Pfizer Consumer Healthcare before she introduced the role of Director of Research Management for Pfizer Oncology. In Sep 2018 Dagmar joined the xSector BRQC organization at J&J.

• 

  Neal Grabowski, MBA, MS

  • TransCelerate IAO Workstream Lead; Head, Signal Management
  • Sanofi, United States

  Neal is the Head of Signal Management at Sanofi responsible for processes and systems enabling product safety oversight. Prior to joining Sanofi, Neal held multiple roles in Patient Safety and Clinical Operations at AbbVie, Amgen, and Genzyme. He holds a BS in mechanical engineering, MS in biomedical engineering and MBA.

• 

  Iordanis Gravanis, DrMed, PhD

  • Scientififc Advice, Scientific Evidence Generation, Human Medicines
  • European Medicines Agency, Netherlands

  Iordanis Gravanis is a medical doctor by training and has a PhD in molecular and cellular pharmacology. He has been at the European Medicines Agency since 2008, having worked initially as scientific officer in the oncology office for 5.5 years managing managing new authorisations and the post-authorisation lifecycle of oncology drugs. He then spent 6 years in a management role helping to improve the management of authorisation and post-authorisation processes and the EMA IT tools which support them. Since March 2020, he is the Head of the Scientific Advice Office of the EMA.

• 

  Fengyun (Vicky) Han

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

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

• 

  Martin Harvey Allchurch, LLM

  • Head of International Affairs
  • European Medicines Agency, Netherlands

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

• 

  Sabine Haubenreisser, PhD, MSc

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

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

• 

  Niklas Hedberg, MPharm

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

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

• 

  Inka Heikkinen, MBA, MSc

  • Regulatory Policy Lead
  • Lundbeck, Denmark

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

• 

  Tony Humphreys, MPharm

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

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

• 

  Bjorg Hunter, MSc

  • Director
  • Novo Nordisk, Denmark

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

• 

  Andras Incze

  • Founder & CEO, Akceso Advisors AG, Switzerland
  • University Lecturer Healthcare Management, B-W State University, Germany, Switzerland

  András Incze is the CEO & Founder of Akceso Advisors, Switzerland and is a university lecturer at Baden-Wuerttemberg Cooperative State University, Germany. Dr. Incze has an MBA from IMD, Lausanne and has a MSc and Doctorate (PhD) from BME Budapest, Hungary. He had attended numerous executive programs at Harvard, Stanford, IMD and INSEAD Universities. He managed pricing & reimbursement for 100 markets, launching successfully general, specialist and orphan drugs. He had global responsibility for patient access programs, that provided free access to lifesaving medication to patients.

• 

  Angelika Joos, MPharm

  • Executive Director, Global Regulatory Policy
  • MSD, Belgium

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

• 

  Sandra Kweder, MD

  • Principal, Drug and Biological Products
  • Greenleaf Health/Elilquent, United States

  Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy. As Principal, Drug and Biological Products, with Greenleaf Health, she offers broad expertise accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

• 

  Lada Leyens, PhD, MSc

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

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

• 

  Volker Liebenberg

  • Chief Medical Officer
  • Elypta, Sweden

  A physician with more than 15 years of experience in the development and commercialization of in-vitro diagnostics (IVD). Focusing on implementation of innovative technologies, especially molecular diagnostics, to improve healthcare at scale. Prior to Elypta he was with several molecular diagnostic companies including QIAGEN GmbH, Thermo Fisher Scientific Inc. and Epigenomics AG, where he gained experience and drove implementation of novel biomarkers and IVD-products across various indications in oncology, infectious disease and prenatal screening. Dr. Liebenberg’s passion is to improve patient care by innovating diagnostic technologies and translating them into routine care.

• 

  Gracie Lieberman, MS

  • Executive Director of Regulatory Policy
  • Genentech, United States

  Gracie Lieberman is a Biostatistician with 30+ years of experience in oncology clinical trials. Gracie is a Director of Regulatory Policy at Genentech and focuses on utilization of RWE in regulatory decision-making. While working at Genentech for the past 22 years, Gracie has gained experience in all phases of drug development, including drug/diagnostic co-development. In 2011, she was a panelist, representing Genentech at the Annual Friends of Cancer Research Clinical Conference.

• 

  Piers Mahon

  • Senior Principal and European Leader
  • Oncology Evidence Networks, IQVIA, United Kingdom

• 

  Patrick Middag, MBA, MSc

  • Principal Lead Regulatory Affairs
  • Servier, Belgium

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

• 

  Alan Morrison, PhD

  • Vice President Regulatory Affairs Intl
  • MSD, United Kingdom

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

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  Mireille Muller, DrSc, PhD, MSc

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

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

• 

  Nobumasa Nakashima

  • Health Policy Director, National Healthcare Policy Secretariat
  • Cabinet Office, Japan

  Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory Affairs at MHLW since 2016, and Senior Director for International Programs and Associate Center Director for Asia Training Center (ATC) at PMDA since 2018. Since 2020, he has been Associate Executive Director (International Programs) and is responsible for enhancing PMDA’s international affairs including cooperation with foreign counterparts and organizations, to advance Agency’s mission of promoting health and safety in Japan.

• 

  Alexander Natz, JD

  • Secretary General
  • European Confederation of Pharmaceutical Entrepreneurs, Belgium

  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.

• 

  Vada A. Perkins, DrSc, MSc

  • Vice President, Global Head of Regulatory Intelligence & Policy
  • Boehringer Ingelheim, United States

  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.

• 

  Grzegorz (Greg) Podrygajlo, PhD

  • GRA CMC Director, Head of Global Manufacturing Support
  • CSL Behring, Switzerland

  Grzegorz (Greg) Podrygajlo, PhD is Head of Global Manufacturing Support, Global Regulatory Affairs CMC for Biologics at CSL Behring. He obtained Master in Medical Biotechnology and PhD in Neuroscience. Greg leads Global Regulatory Strategy for optimal Change Control Process and Life Cycle Activities including interactions with 4x manufacturing sites and various stakeholders (e.g. Global Quality and Systems). He is also a Business Process Lead for new Regulatory Information Management system and its integration with new Quality Management System. Greg oversees as a key Regulatory SME the expansion of strategic projects such as new facilities or production lines. He has strong expertise in technical CMC, GMP, ICH and genAI topics.

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  Matt Popkin, PhD

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

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

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  Lisa Prach, PhD, MPH

  • Epidemiologist
  • Novartis, Switzerland

• 

  Stephan Roenninger, DrSc

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

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

• 

  Ronenn Roubenoff

  • Novartis Institutes For Biomedical Research, Inc., United States

• 

  Bettina Ryll

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

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

• 

  Jenny Sharpe, PhD

  • Senior Scientific Writer
  • Centre for Innovation in Regulatory Science (CIRS), United Kingdom

  Jenny is currently Senior Scientific Writer at the Centre for Innovation in Regulatory Science (CIRS). CIRS is an independent, academic organisation that provides an international forum for industry, regulators, HTA bodies and other healthcare stakeholders to meet, debate and develop regulatory and reimbursement policies and processes. Before joining CIRS in 2019, Jenny worked as Research Communications Manager for rare disease patient group Muscular Dystrophy UK for four years. She has a PhD in Mitochondrial Biology from University College London (UCL) and a BSc in Biochemistry from Bristol University.

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  Renske Ten Ham, PharmD, MSc

  • Assistant Professor
  • UMC Utrecht, Netherlands

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  Shannon Thor, PharmD, MS

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

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

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  Aimad Torqui

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

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

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  Kristel Van De Voorde, MPharm

  • Senior Director, Pharmacovigilance QA
  • GSK, Belgium

  Kristel Van de Voorde is a pharmacist and has more than 25 years of experience in the quality area covering GCP,GVP and interfaces in R&D with GLP and GMP. Currently, Kristel is the global head of the quality function for pharmacovigilance at GSK. Her main responsibilities are to oversee the strategy and execution of the audit schedule related to pharmacovigilance, manage health authority inspections and support building a strong Quality Management System aiming for proactive risk identification.

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  Max Wegner, PharmD, RPh

  • Head Regulatory Affairs
  • Bayer AG, Germany

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

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  Fia Westerholm, DVM, MSc

  • Programme Assurance Manager
  • European Medicines Agency, Netherlands

  Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences. More than 20 years of experience alternating between private and public sector in the area of medicines, including in research and development, assessment and regulation of medicines as well as management at EU & national level. At EMA since 2005.

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  Amira Younes

  • Director, Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy
  • MSD, United Arab Emirates

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

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  Reem Yunis, PhD

  • Vice President, Digital Transformation Strategy
  • Medable, United States

  Dr. Yunis is a scientist with multidisciplinary training and expertise in mechanism of diseases. She enjoys working in startups bringing forward long term vision and strategies. Reem is dedicated to modernizing clinical development by leading efforts at the intersection of technology, science and data. At Medable, she works cross-functionally with engineers, product development, regulatory, and data science to develop first-in-class DCT solutions. She is also leading the scientific development of digital clinical measures. Reem holds a PhD in genetics from the Hebrew University of Jerusalem.

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  Martine Zimmermann, PharmD

  • Senior Vice President, Head of Global Regulatory Affairs
  • Ipsen , France

  Martine Zimmermann is Senior Vice President, Head of Regulatory Affairs, & Quality R&D at Ipsen since January 2023. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion Pharmaceuticals, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board of Inventiva Pharma.

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  Samvel Azatyan, MD, PhD

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

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

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  Ane Sofie Böhm Nielsen, MA, MPA

  • VP, Regulatory Policy & Intelligence
  • Novo Nordisk A/S, Denmark

  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.

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  Francesca Cerreta, PharmD, MPharm, MS

  • Principal Scientific Officer
  • European Medicines Agency, Netherlands

  After working for Lilly and Merck, Francesca Cerreta joined the EMA in 1996. There, she has set up the parallel scientific advice programme with FDA, worked in CNS and Scientific Advice, and coordinated the PRIME scheme, the digital therapeutic matrix, and the geriatric medicines strategy activities.

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  Vicki Edwards, RPh

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

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

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  Giovanna Ferrari, PhD

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

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

• 

  Isabelle Huys, PharmD, PhD, MPharm

  • Professor
  • KU Leuven, Belgium

  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.

• 

  Teodora Lalova, LLM

  • PhD student
  • KU Leuven and EORTC, Belgium

• 

  Anne Moen, PhD, MSc, RN

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

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

• 

  Ronnie Harprit Mundair

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

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

• 

  Vivek Muthu, MD, MA

  • Director
  • Marivek Ltd., United Kingdom

  Dr Vivek Muthu is a physician and entrepreneur specialising in health system value and efficiency. His company focused on the application of analytics and evidence to deliver high quality, safe, cost effective care and to maximise health resource utilisation and value. It was acquired by The Economist Group, to found and grow the Economist’s global healthcare practice under Vivek’s leadership. He is now an independent consultant, working with public, private and NGO stakeholders across healthcare, and is a director of companies in the biotech and healthcare data analytics sectors. He holds a first class degree in neurophysiology from Cambridge University, and a medical degree from Oxford University.

• 

  Margareth Ndomondo-Sigonda

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

• 

  Wija Oortwijn, PhD, MSc

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

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

• 

  Rodrigo Palacios, MBA

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

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

• 

  Frank Petavy, MS

  • Head of Methodology
  • European Medicines Agency, Netherlands

  Frank Pétavy is head of Methodology in the EMA Task Force on Data, Analytics and Methods. His team at EMA provides expert advice to sponsors during drug development and in the assessment of marketing authorisation applications across therapeutic areas. Frank also coordinates activities of the group of European statistical assessors, the Biostatistics Working Party, which includes the development of methodology guidelines. Frank has been or is still involved in ICH working groups on estimands, adaptive designs and the clinical electronic structured harmonised protocol. Frank holds a post-graduate diploma in biostatistics. Prior to EMA, he spent 14 years working in clinical development in the pharmaceutical industry in Spain and in the UK.

• 

  James Pickett

  • Health Data Research UK, United Kingdom

  James is the Hub Development Manager at HDR UK, working to further develop the portfolio of HDR UK Data Research Hubs, and increase their engagement with data users. James is working to integrate the Hubs into national infrastructure for health data research, including the HDR UK Innovation Gateway for discovery of UK health data, and the UK Health Data Research Alliance that is developing best practices and standards for data sharing. James has a research background in dementia and a PhD from the University of Cambridge.

• 

  Sibilia Quilici

  • Executive Director
  • Vaccines Europe, Belgium

  Sibilia Quilici (MBA, MSc). Executive Director of Vaccines Europe at EFPIA - European Federation of Pharmaceutical Industries and Associations. Vaccines Europe (VE) represents major innovative research-based vaccine companies operating in Europe, including small and medium-sized enterprises. Sibilia holds an International MBA in entrepreneurship and MSc in Health Economics & Biostatistics. With more than 12 years of experience in working on vaccines, she holds a track record in studies valuing the full benefits of preventative measures (such as vaccines), from a micro and macro socio-medico-economic perspective, addressing all relevant stakeholder concerns (government, industry, society, healthcare professionals and citizens).

• 

  Guido Rasi, MD

  • Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology
  • Tor Vergata University of Rome, Italy

  Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member of its Management Board in the three years prior to this. He was Director-General of the Italian Medicines Agency (2008-2011) and member of the Management Board (2004-2008). He was made full professor of microbiology at the University of Rome 'Tor Vergata' in 2008. He holds a degree in medicine and surgery, with specialisations in internal medicine, allergology and clinical immunology, from the University of Rome.

• 

  Julien Romanetto, PharmD

  • Regulatory Affairs Manger
  • Transgene S.A., France

  Julien Romanetto, PharmD, is Regulatory Affairs Manager within Transgene S.A. He is working as regulatory representative in different Investigational ATMP project teams notably in charge of clinical trial submission and maintenance activities. He has also responsibilities for Regulatory Intelligence and represents Transgene S.A. in some working groups from European and French national trade associations (i.e., EFPIA and France Biotech).

• 

  Kay Snowley

  • Health Data Research UK, United Kingdom

  Kay leads the operations of Health data Hub network and their integration into the data infrastructure and services being developed by HDR UK and across UK. Kay has over 15 years’ experience working in the Higher Education Sector, primarily in leading, managing and delivering large multi stakeholder projects and innovations across the East Midlands. A specialist in developing and implementing commercial and research services, including Continuous Professional Development (CPD), specialised business units, Executive Education and Knowledge Exchange opportunities.

• 

  Rebecca Stanbrook, RPh

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

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

• 

  Paula Walker, MA

  • Global Head of Risk Based Quality Management
  • Roche Products Ltd., United Kingdom

  Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has a BSc in Biomedical Science, MA in Biotechnological Law & Ethics, and a Post-Graduate Diploma in Clinical Trials. In 2020/21 Paula chaired the ICMRA working group on Remote GCP & GMP inspections, and was a founding member of the MHRA's Innovative Licensing & Access Pathway (ILAP) Steering Group. Paula has extensive experience working across global regulators and industry collaborations, currently as part of the IMPALA Quality Brief Consortium working group.

• 

  Markus Zeitz

  • Head of Global Quality Digital Transformation
  • Boehringer Ingelheim, Germany

• 

  Sarah Adam

  • Associate Director, Regulatory Affairs
  • IFPMA, Switzerland

  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.

• 

  Andre Araujo, PhD

  • Head of Real-World Analytics (RWA)
  • GlaxoSmithKline, United States

  Andre B. Araujo, PhD is an epidemiologist and is the Head of Real-World Analytics (RWA) at GSK. The RWA team is composed of analysts and data scientists who provide design and analytics to support the generation of high-quality real-world evidence in support of the GSK portfolio. His external engagements include initiatives that focus on best practices in the application of research methods to real-world data in the context of non-interventional study designs.

• 

  Gesine Bejeuhr, PharmD

  • Pediatric Regulatory Leader
  • Bayer AG, Germany

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

• 

  Karl Broich, DrMed

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

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

• 

  Darcy Forman

  • Chief Delivery Officer
  • Science37, United States

  Darcy Forman, Chief Delivery Officer for Science 37, has responsibility and oversight for clinical operations service delivery, including patient engagement, clinical operations, data management, and nursing solutions. She has more than 20 years of experience bridging clinical operational expertise and strategic corporate development initiatives with a passion for innovative and decentralized clinical trial execution. Most recently, Darcy served as the vice president of corporate development at Firma Clinical Research, where she had oversight and leadership responsibility for the identification, development, and execution of corporate development opportunities, including the evaluation of Firma corporate strategies and strategic planning.

• 

  Marco Greco, PhD

  • President
  • European Patients' Forum, Belgium

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

• 

  Cesar Hernandez Garcia

  • Head of Department, Department of Medicines for Human Use
  • Spanish Agency For Medicines and Medical Devices, Spain

  Dr. César Hernández MD, PhD. joined the Spanish Agency for Medicines and Medical Devices as a Head of the Human Medicines Department in 2009. Prior to joining, he was the deputy Medical Director of the Hospital Clínico San Carlos in Madrid for three years. He previously worked as rheumatologist at the same Hospital for 16 years also developing functions as associate professor of Medicine and principal and associate investigator in several research projects financed by public and/or private funds in areas such as basic research, clinical research and health care services. He graduated from medicine and surgery, specialist in Rheumatology in 1987 at the Complutense University of Madrid and received his PhD in 1996 at the same university.

• 

  Claudia Hey, DrSc, PharmD

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

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

• 

  Nadege Le Roux, PhD

  • Regulatory Policy Senior Director
  • Bristol Myers Squibb, Switzerland

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

• 

  Anne Litzen

  • Executive Director Regulatory Affairs Management
  • AstraZeneca R&D, Sweden

• 

  Marcin Czech

  • ISPOR Poland, Former Deputy Minister of Health, Poland

• 

  Andreas Fuerer

  • Case Manager
  • Swissmedic, Switzerland

  Andreas Fürer made his Diploma in Chemistry at the University of Bern and the PhD studies at the ETH Zürich. His first place of work was in the Research and Development for bacterial vaccines in the former Swiss Serum and Vaccine Institute in Bern. In 2006, he changed into the Regulatory Affairs department at Berna Biotech (which became later Crucell and then Jannsen Vaccines). In 2013, he joined Swissmedic as a Case Manager and since 2016, he is in charge for the radiopharmaceuticals.

• 

  Lina Nordquist

  • Member of Swedish Parliament (Liberalerna), Sweden

• 

  Wolfgang Philipp

  • Head of Unit Intelligence and Innovation
  • European Commission, Belgium

• 

  Eva Thomsen

  • Regulatory Affairs Senior Director
  • Novo Nordisk A/S, Denmark

• 

  Thorsten Vetter, DrMed

  • Senior Scientific Officer, Scientific Advice
  • European Medicines Agency, Netherlands

  MD, Board certified Clinical Pharmacologist, Senior Scientific Officer, Scientific Advice Office, European Medicines Agency

• 

  Ardy Arianpour

  • CEO & Co-Founder of SEQSTER, United States

  Ardy Arianpour is CEO & Co-Founder of Seqster, the leading patient-centric SaaS healthcare technology company that enables organizations to drive efficient healthcare via comprehensive medical records (EHR), individual genomic profiles (DNA), and personal health device data for users for the first time across all of their US-based healthcare data sources through person-centric interoperability. Ardy is a visionary health tech executive and serial entrepreneur in biotech and digital health, with a BS in Biological Sciences from UC Irvine and MBA from Marshall Goldsmith School of Management. He was a Medical, Marketing, and Media’s (MM&M) Top 40 Healthcare Transformer and San Diego Business Journal 40 under 40.

• 

  Neil Bertelsen, MBA, MSc

  • Chair, Patient and Citizen Involvement in HTA IG
  • Health Technology Assessment international (HTAi), Germany

  Neil is Chair of HTAi's Interest Group on Patient and Citizen Involvement in HTA. The HTAi Patient and Citizen involvement Interest Group is an international group whose remit is to work closely with HTA organisations, patient organisations and the research community to bring patient perspectives and experiences into decision making processes. Neil is also an independent consultant with over 25 years of experience working with advocates, the industry and decision makers to improve healthcare.

• 

  Lourens Bloem, PharmD, PhD, MSc

  • Assistant Professor Clinical Therapeutics
  • Utrecht University, Netherlands

  Lourens Bloem (PharmD, PhD) is assistant professor at Utrecht University, The Netherlands. He was trained as a pharmacist and holds a PhD from the Utrecht Institute for Pharmaceutical Sciences (UIPS). Next to his doctoral studies, he worked as pharmacovigilance assessor at the Dutch Medicines Evaluation Board. His research focuses on Drug Regulatory Science, especially on aspects of evidence generation for regulatory decision-making and their effects on downstream decision-making, for example on reimbursement or in clinical practice. In addition, he is Programme Manager Drug Regulatory Science for the Utrecht Science Park, drawing on his research experience as well as previous work experience at the Dutch Medicines Evaluation Board.

• 

  Kristof Bonnarens, MPharm

  • Policy Officer Pharmaceuticals
  • European Commission, Belgium

  Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications. He was the Belgian member and secretary of the Clinical Trial Facilitation Group, and the Belgian representative in the European Commissions Clinical Trial Expert Group. He was also part of the negotiations of the Clinical Trial Regulation in 2013 and 2014. After a brief period working for the association of the Belgian pharmaceutical industry from 2016 onwards, he joined the EU Commission in 2019.

• 

  Erwin P Bottinger

  • Co-Director
  • Hasso Plattner Institute for Digital Health, Mount Sinai, United States

• 

  Anne Bourrelly, MBA, MSc

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

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

• 

  Christelle Bouygues, PharmD

  • Regulatory Affairs Senior Officer
  • European Medicines Agency, Netherlands

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

• 

  Iain Buchan

  • Chair in Public Health and Clinical Informatics, and Executive Dean
  • Institute of Population Health, United Kingdom

  Iain Buchan is Chair in Public Health and Clinical Informatics and Associate Pro Vice Chancellor for Innovation at the University of Liverpool. He is a leading researcher and innovator at the interface of public health and data science, and most recently led delivery of world first evidence on SARS-CoV-2 rapid antigen testing in Covid-19 responses. Previously, he grew the UK’s largest health informatics research team at Manchester. He has developed popular scientific, engineering, and social approaches to health data, and led multi-disciplinary research centre. He holds qualifications in pharmacology, clinical medicine, public health, statistics and informatics. He has been driving digital innovation projects for over 30 years.

• 

  Emese Csoke

  • Global Regulatory Medical Safety and Compliance (RMSC) Strategy Director
  • Bayer Consumer Health, Switzerland

• 

  Charlie Davie

  • UCL Partners, United Kingdom

  Charlie Davie is Hub Director for DATA-CAN and a practising Consultant Neurologist at the Royal Free London NHS Foundation Trust. He previously held the role of Managing Director for UCLPartners where he played an integral leadership role since 2009. He also led the reconfiguration of services and establishment of Hyper Acute Stroke Units in London. Charlie has held a number of national advisory roles, most recently as a member of the Accelerated Access Review Implementation Group working with the Office of Life Sciences and NHS England, and was a member of Rt Hon George Freeman’s Life Sciences Cabinet. Charlie has over 30 years’ continuous clinical service in the NHS and is a Fellow of the Royal College of Physicians.

• 

  Saskia de Wildt, DrSc, MD

  • Professor of Clinical Pharmacology, Pediatric Intensivist
  • Radboud University Medical Center, Netherlands

  Professor Saskia de Wildt is Chair of Clinical Pharmacology and pediatric intensivist at Radboud University, the Netherlands. She has published over 190 peer-review international papers and received over 8 million euros PI research funding. Her research, largely supported by grants from ZonMW, EU and the Bill and Melinda Gates Foundation, aims to individualize drug therapy in children and pregnant women. In leadership roles as WP lead for Strategic Feasibility Advice and director of the Dutch trialnetwork PEDMED-NL, she contributes to IMI2 project Conect4children (140 million euros) which to build EU pediatric clinical trial infrastructure. She is also director of the Dutch and International Pediatric Formulary consortium.

• 

  Patricia Dewaele

  • Director, Global Quality Regulatory Compliance
  • Bristol-Myers Squibb, Belgium

• 

  Jane Feron

  • Risk Management Director
  • AstraZeneca UK Ltd, United Kingdom

  Jane Feron BSc (Hons) has spent most of here working life in the pharmaceutical industry. After working in Clinical Research for nearly 10 years, she joined the PV department at AstraZeneca. She worked in safety surveillance before becoming the process owner for Risk Management and subsequently taking the role of PV processes lead, where she was responsible for all the PV processes at AstraZeneca. Currently she is a Risk Management Director and is responsible for developing risk minimisation strategies primarily for the oncology portfolio, supporting affiliates in the implementation of local risk management regulations and risk minimisation measures, and maintaining global oversight of risk management activities internally and externally.

• 

  Peg Fletcher, MD, PhD

  • President
  • MedAssessment, Inc., United States

  Peg received her MD & PhD (biochemistry) from U Chicago and boards in Oncology and Clinical Pharmacology. A safety executive with over 25 years’ experience in development and PVG in large and small pharma, Peg developed TAP Pharma's safety review process, led the protocol review team, and served on the Am Board of Clin Pharm. For the past 12 years she has led MedAssessment, a small PVG CRO focused on safety in early development.

• 

  Maria Florez, MA

  • Researcher
  • Pharma As Patients, United States

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

• 

  Mick Foy

  • Director of Delivery
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

  Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

• 

  Juan Garcia-Burgos, MD, PhD

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

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

• 

  Rogerio PAULO Gaspar, PharmD

  • Director, Regulation and Prequalification Department
  • World Health Organization (WHO), Switzerland

  Dr. Rogério Gaspar from Portugal joined WHO January 6, 2021, as the Director of Regulation and Prequalification Department. He obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after a graduation as pharmacist from the University of Coimbra Portugal. He was a Full Professor at the Faculty of Pharmacy University of Lisbon until the end 2020, where he was Head of Department and President of the School Council. He was a member of the management board of EMA and VP of the management board at Portugal’s NRA (INFARMED). He also participated in activities against medicines counterfeiting and from 2000-2002 lead the participation of Portugal within International Narcotics Control Board (INCB).

• 

  Thierry Gastineau, PharmD

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

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

• 

  Stefan Gijssels

  • Patient Expert Center (PEC), Belgium

  In 2016, after recovering from a metastatic colon cancer, Stefan Gijssels became a patient advocate and health policy consultant. Stefan is the pro bono Chair of the Patient Expert Center (PEC) in Belgium, an organisation that trains members of patient organisations to become patient experts in their disease area. He is Patient Expert at Sharing Progress in Cancer Care (SPCC), the international organisation created by the European School of Oncology. Stefan Gijssels is a health policy consultant, publicist and speaker, primarily focused on making health systems more patient-centric and smarter.

• 

  Flora Giorgio, MPharm

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

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

• 

  Amelie Goyer, DrSc, PhD, PMP

  • Clinical Project Manager
  • Nestec Ltd., Switzerland

• 

  Miriam Guest

  • Associate Principal Scientist
  • Astrazeneca, United Kingdom

• 

  Christian Hay

  • GS1 Global Office, Belgium

• 

  Tobias Heimann, PhD

  • Head of Artificial Intelligence Germany
  • Siemens Healthineers, Germany

  Tobias Heimann studied Medical Informatics at the University of Heidelberg and obtained his Ph.D. on 3D medical image analysis with statistical shape models. After a number of years in academia, he joined Siemens as research scientist for imaging and computer vision in 2012. Since 2016, he is leading the team Artificial Intelligence Germany, which is part of the Digital Technology & Innovation department of Siemens Healthineers and focuses on research and translation of machine learning technology for healthcare. Apart from AI, the team is pioneering Digital Twin technologies for healthcare for a number of clinical use cases.

• 

  Asim Hocaoglu

  • Vice President of Medicines and Pharmacy
  • Turkey Pharmaceuticals and Medical Devices Agency (TITCK), Turkey

  Started his employment in Social Insurance Institution SSK Buca Hospital after graduating from Faculty of Science, Department of Biology of Hacettepe University in 1999. In his years in Ankara Occupational Diseases Hospital of Health Ministry between 2003-2011, Mr. Hocaoglu carried out modernization of hospital clinical laboratories and establishment of a new occupational toxicology laboratory. After being assigned to Turkish Medicines and Medical Devices Agency in 2011, having a Ph.D. degree in Toxicology he has been carrying out missions in clinical investigation requirements and biocompatibility assessment. Served in various fields of health since 2002, Dr. Hocaoglu has been occupied as VP of Titck since 2021.

• 

  Dave Anthony Leather, DrMed, FFPM

  • Independent Consultant Pharmaceutical Physician
  • Indepenedent, France

  Dave Leather is freelance Consultant pharmaceutical physician and a fellow of the Royal College of GPs and of the Faculty of Pharmaceutical medicine Formerly he was Medical vice President and Global Medical Head of inhaled asthma therapies for GSK based in London. He joined GSK in 2000 and held a variety or roles in the company. At GSK he had a leadership role in “real world pragmatic trials” and was the leader of the internationally recognised Salford Lung Study, and has published extensively in this area. His major interests are in clinical trial design, treatment pathways and treatable traits in airways disease Originally a UK GP UK, he was a GP Course Organiser, a member of the Council of the Royal College of GPs

• 

  Judith Catherine Macdonald

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

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

• 

  Janet Nooney, PhD, FFPM

  • Expert Scientific Assessor, VRMM- Benefit Risk Management
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

  Dr Janet Nooney is an expert scientific assessor in pharmacovigilance at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dr Nooney divides her time between co-ordinating the MHRA’s strategy on improving information for use of medicines during pregnancy and breastfeeding and assessing safety issues for new and established medicines. Her work includes assessing risk management plans for new medicines and applications to maintain or vary marketed medicines, especially in the fields of lipid regulation and women’s health, and monitoring safety of medicines use during pregnancy. She is Principal Assessor to the Medicines for Women’s Health Expert Advisory Group to the Commission on Human Medicines (CHM).

• 

  Irene Norstedt

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

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

• 

  Magdalini Papadaki, PhD, MBA, MSc

  • Director, Regulatory Affairs International
  • MSD, United Kingdom

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

• 

  Francesco Patalano, DrMed

  • Head of Pediatric & Patient Reported Outcomes Centers of Excellence
  • Novartis, Switzerland

  Francesco is the Head of Centers of Excellence for PRO and Pediatric development, within Novartis Global Drug Development. Francesco is MD with specialization in Respiratory Medicine, Allergy and Clinical Immunology. Former Senior Global Program Head, Francesco has 30 years experience in drug development, with a track record of several products developed to approval.

• 

  Andrzej Rys, MD

  • Principal Scientific Advisor
  • European Commission, European Union, Belgium

  Andrzej Rys is Director responsible for Health Systems, Medical Products and Innovation at the European Commission, Directorate-General for Health and Food Safety since 2014. He is a medical doctor specialised in radiology and public health, graduated from Jagiellonian University, Krakow, where he founded the School of Public Health (1991). After being Director of Krakow’s City Health Department (1997), he served as Deputy Minister of Health in Poland (1999). Founder and director of Center of Technology Transfer and Jagiellonian University, CITTTU). He joined the European Commission in 2006 where he became Director for Public Health and Risk Assessment.

• 

  Florian Schmidt, JD, LLM

  • Deputy Head of Unit B5 – Medicines: Policy, Authorisation and Monitoring
  • DG SANTE, European Commission, Belgium

  Florian Schmidt is the deputy head of unit of the Commission’s pharmaceutical unit B.5 in the Directorate-General for Health and Food Safety (DG SANTE). He is a lawyer by training and joined the Commission in 2004. For several years he followed the paediatric legislation and participated in meetings of the Paediatric Committee at EMA. He was involved in the drafting of the 2013 Commission Report on the Paediatric Regulation and the subsequent 2017 report, which was published end of 2017.

• 

  Peter Schüffler

  • Technical University of Munich, Germany

  Prof. Schüffler received his BSc and MSc in Computational Biology at the Saarland University and the MPI, Saarbrücken, Germany. In 2015, he graduated his doctoral studies in machine learning for medical image data analysis at the ETH Zurich, Switzerland. He deepened his expertise in digital and computational pathology as a Postdoc and Sr. ML Scientist at the Memorial Sloan Kettering Cancer Center New York, USA, where he co-founded Paige. In 2021, Prof. Schüffler was appointed to the professorship for computational pathology at the TUM. Prof. Schüffler's field of research is the area of digital and computational pathology.

• 

  Carrie Scott

  • Head, Global PV Compliance and Policy, Pharmacovigilance and Patient Safety
  • AbbVie Ltd, Portugal

  Currently Director of Global Safety Compliance, with responsibility to set strategic direction for an optimised pharmacovigilance quality management system. Carrie holds a BSc Biochemistry with Pharmacology. Carrie worked at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, holding a variety of positions, including Pharmacovigilance Inspectorate Operations Manager & Senior Pharmacovigilance Inspector, and other roles in the Enforcement and Post-Licensing Divisions. Carrie took a lead role in the publication of the MHRA's Good Pharmacovigilance Practice Guide and also contributed to the development of the EU Good Vigilance Practice modules. Carrie has also held other PV Compliance and Quality Assurance roles.

• 

  Patterson Shafer

  • Managing Director
  • FTI Consulting, Inc., United States

  Pat Shafer is a Managing Director at FTI Consulting. He is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. He currently leads the development of the RIM Whitepaper 3.0 as part of the RIM Working Group, and leads the Culture of Quality initiative as part of the FDA/MDIC Case for Quality.

• 

  Isabelle Stoeckert, PharmD, PMP

  • VP. Head Regulatory Affairs Europe Middle East Africa
  • Bayer, Germany

  Dr. Isabelle Stoeckert is Vice President and Head Regulatory Affairs Europe Middle East Africa at Bayer AG. With more than 20 years of experience in Regulatory Affairs she held several leading positions in a wide area of Regulatory and Scientific Affairs matters. Such as Vice President, Head of Global Strategy and Director, Head of Regulatory Affairs International at Bayer HealthCare AG. She is member of several EFPIA committees.

• 

  Rick Vreman

  • Patient Access Manager
  • Roche, Netherlands

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

• 

  Chantal Walther, MPharm

  • Head Regulatory Assessment Unit 4
  • Swissmedic, Switzerland

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

• 

  Jun Wang

  • Director of Department of Biostatistics and Clinical Pharmacology,
  • National Medical Products Administration (NMPA) , China

• 

  Naoyuki Yasuda, MSc

  • Associate Executive Director , Office of International Programs
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals and medical devices international issues. He has taken his current position from Jul., 2018. He is one of Assembly and Management Committee Members of ICH from Japan.

• 

  Gabriela Zenhaeusern, PhD

  • Deputy Head Stakeholder Engagement
  • Swissmedic, Switzerland

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

• 

  Bandar Al Hammad, MPharm

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

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

• 

  Jacqueline Bowman-Busato

  • Co-Founder,Engagement and Projects Lead
  • Adipositas Pact Stichting, Belgium

• 

  Zoltán Kaló

  • Professor of Health Economics
  • Center for Health Technology Assessment, Semmelweis University, Hungary

• 

  Yann Le Cam, MBA

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

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

• 

  Rana Malkawi

  • Drug Directorate Director
  • Jordan Food and Drug Administration (JFDA), Jordan

  Dr Rana is an experienced pharmacist with more than 15 years of experience in Regulatory affairs, holding a master degree in pharmaceutical quality assurance. She joined JFDA in 2008 and held various positions, including head of new drugs registration section, head of biological and vaccine registration section. She was the Project lead for the installation of the eCTD system at JFDA and collaborated in the preparation and review of the “Guidance for Registration of Biosimilars in Jordan” from May 2015. Currently, Dr Rana is the head of Clinical Studies Department at JFDA, a member of the Clinical studies and of the national stem cells committee and the MOH clinical trials and access to innovation committee.

• 

  Pauline Meij

  • Head of Production ATMP / Qualified Person
  • Department of Clinical Pharmacy and Toxicology, Leiden Univ, Netherlands

  Pauline Meij is the head of the facility for cell and gene therapy (CCG) at the Leiden University Medical Center (LUMC). She is responsible for the production of ATMPs at the LUMC, Qualified Person and she is actively involved in the project management of the clinical translation of ATMPs. The research focus of Pauline Meij is on the clinical translation of cell therapy and gene therapy products and their implementation in regular clinical practice, she was the lead author of the LERU ATMP briefing paper. Pauline Meij is a member of the ATMP expert group of the Dutch Medicines Evaluation Board and board member of the ATMP working party of The Netherlands and Belgium.

• 

  Elizabeth Miller, PharmD

  • Assistant Commissioner For Medical Products and Tobacco Operations, ORA
  • FDA, United States

  Dr. Elizabeth Miller recently rejoined the US FDA in March 2020. In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.

• 

  Marleen Vandecapelle

  • Coordinator Nuclear Medicine
  • Federal Agency For Nuclear Control, Belgium

  Marleen graduated as Bachelor in Chemistry at the Ghent University where she obtained a PhD. in radiopharmacy and her university degree of medical radiation physicist (nuclear medicine). Since 2005, she has been working for the Belgian radiation protection competent authority in the department of Health Protection. She is member of the advisory committee on radiopharmaceutical products on the reimbursement of these products of the Belgian reimbursement institution and gives advice on radiopharmaceuticals to the Commission on Medicinal Products of the Belgian Medicinal Products Agency. She is member of the Working Group on Medical Applications of HERCA.

• 

  Grigorios Agkyralidis, MSc

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

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

• 

  Janis Bernat, MSc

  • Director, Scientific and Regulatory Affairs
  • IFPMA, Switzerland

  Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team to successfully deliver its policy objectives and advocate for improved regulatory system strengthening. Prior to joining IFPMA, Janis worked in quality assurance and regulatory compliance for a US-based multinational company specializing in food service and retail. Janis holds a Master of Science in Communication-Public Relations and a Bachelor of Science in Agriculture-Food Science.

• 

  Michael Berntgen, PhD

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

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

• 

  Emer Cooke, MBA, MSc

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

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

• 

  Nancy A Dreyer, PhD, MPH, FISPE

  • Founder
  • Dreyer Strategies LLC, United States

  Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

• 

  Hans-Georg Eichler, MD, MSc

  • Consulting Physician
  • Austrian Association of Social Security Bodies, Austria

  Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association.

• 

  Bogi Eliasen

  • Director of Health
  • Copenhagen Institute For Futures Studies, Denmark

• 

  Harald Enzmann, DrMed, MD, MS, MSc

  • Chair, CHMP; Section Head of European and International Affairs;
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany

  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.

• 

  Christine Fletcher, MSc

  • VP/Head, Speciality and Primary Care Statistics
  • GlaxoSmithKline, United Kingdom

  Chrissie is the VP Speciality & Primary Care Statistics at GSK. Chrissie has worked in the Pharmaceutical Industry for over 30 years and has experience of developing and commercialising new medicines in a variety of therapeutic areas across all phases of clinical development. Chrissie is actively engaged in Statistical societies, Pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. She is currently the Chair of the Statisticians in the Pharmaceutical Industry (PSI), the EFPIA lead for the Innovation in Clinical Trials Pillar, a working group in the Clinical Research Expert Group, she is one of the PSI representatives on the EFSPI Council and she is the lead for the EFSPI Statistics Leaders Forum.

• 

  Yasuhiro Fujiwara, MD, PhD

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

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

• 

  Robert Gaertner

  • Director Europe - Strategy Vault Quality
  • Veeva Systems, Germany

  Robert Gaertner is a Senior Director of Strategy for Quality at Veeva Systems. With more than 20 years of experience in the life sciences industry, he has a deep understanding of quality processes and systems in GxP-related areas. Starting his career in the pharma industry, Robert worked as a consultant and led implementation programs, including eDMS, eQMS and LIMS. In his current role at Veeva, Robert is leading Veeva’s strategic activities for Quality & Manufacturing in Europe.

• 

  Thomas Griffiths

  • Product Strategy and Service Design Director
  • AstraZeneca, United Kingdom

  Thomas specialises in healthcare strategy and digital innovation Thomas brings expertise from the start up world together with digital transformation to help health systems design and adopt new pathways that improve patient outcomes and increase care efficiency. Thomas is focused on rapid experimentation and creating new business models helping to modernise care systems.

• 

  Renske Grupstra

  • Graduate research intern
  • Utrecht University, Netherlands

  I am a Master’s student in the Drug Innovation program at the Utrecht University. Prior to this, I completed an interdisciplinary Bachelor at the University of Amsterdam and majored in chemistry. As part of an internship at the Pharmacoepidemiology and Clinical Pharmacology group of the Utrecht University, I was part of research into remote methods in clinical trials, of which some results are presented here at DIA. Currently I am conducting another internship -this time at the European Medicines Agency-, where I focus on risk minimisation measures and their effectiveness.

• 

  Ylva Hedberg, MS

  • Director
  • AstraZeneca, Sweden

  Ylva Hedberg has over 20 years experience in the pharmaceutical industry and has held different roles in process technology, quality, and regulatory. For the past 13 years, Ylva has specialized on regulatory CMC requirements focusing on marketing applications and postapproval submissions. Ylva has a wide range of experience in the strategic aspects of rolling out marketing applications globally and has played an instrumental role in setting the CMC content of marketing applications. Ylva js CMC Regulatory Affairs Director at AstraZeneca with a MSc in chemical engineering from the Royal Institute of Technology, Stockholm, Sweden.

• 

  Esteban Herrero-Martinez, PhD

  • Director Regulatory Policy and Intelligence
  • AbbVie, United Kingdom

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

• 

  Yu Huan

  • Center for Drug Evaluation, National Medical Products Administration, China

• 

  Martin Huber, MPH, MPharm

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

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

• 

  Alexa Hunter

  • Director EU Global Regulatory and Scientific Policy
  • Merck KGaA, Germany

• 

  Lea La Bella

  • Director Regulatory Affairs
  • Moderna Switzerland GmbH, Switzerland

• 

  Beatrice Lavery, MS

  • Vice President, Regulatory Portfolio Strategy Lead
  • Roche, Switzerland

  Beatrice (Bea) Lavery is the Vice President, Global Head of Oncology Regulatory at F. Hoffmann-La Roche. Originally from Canada, Bea received her Bachelors and Masters Degrees from the University of Calgary, specializing in Microbiology and Infectious Disease research. Bea is currently based in Basel, Switzerland.

• 

  Geneviève Le Visage, PharmD, MSc

  • Head EU RA Policy and Liaison
  • Novartis Pharma AG, Switzerland

  Pharmacist by training, with a masters in Science Communication Currently heads the team responsible for regulatory intelligence and policy for the EU for Novartis in Basel, Switzerland, supporting project teams in establishing their strategy for filing in the EU, including for paediatrics, and bringing this experience to ongoing discussions on the Paediatric Regulation. Prior to this, she worked for ten years at the European Medicines Agency in London, mainly in the field of information for the public. Chair of the EFPIA Paediatric Expert Group.

• 

  Niels Buch Leander, PhD

  • Vice President, R&D
  • NNIT, Denmark

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

• 

  Helen Lee

  • Health and Food Safety Directorate-General
  • European Commission, Belgium

• 

  Lubos Michalov

  • User Advisory Group Member; Finance Manager
  • Gravitate Health; Slovak Environmental Agency, Slovakia

• 

  Vera Mucaj, PhD

  • Chief Scientific Officer
  • Datavant, United States

  Vera is the Chief Scientific Officer at Datavant. She leads a team focused on developing the technical product, and defining key use cases for connected health data in research. Vera is a research scientist by training, and holds a BA in Biochemistry from Harvard College, and a PhD in Cell and Molecular Biology from the University of Pennsylvania Perelman School of Medicine. She has authored multiple peer-reviewed scientific papers in cancer research. Prior to joining Datavant, Vera worked at McKinsey & Company, where she supported pharmaceutical clients on growth strategy, business development, and M&A.

• 

  Fai Ng

  • Musculoskeletal Research Group, Faculty of Medical Sciences
  • Newcastle University, United Kingdom

• 

  Judith Ng-Cashin, MD

  • Chief Executive Officer and President
  • JNC Consulting, United States

  Judith Ng-Cashin, MD, former Chief Medical Officer at Eagle Pharmaceuticals, leading R&D across the development pipeline and marketed products. Prior to this role, she served as CMO for AOBiome Therapeutics, leading end-to-end asset development strategy, medical governance, and manufacturing. She also served as Chief Scientific Officer and led the Safety & Pharmacovigilance business unit for Syneos Health. Before Syneos, she spent nearly a decade in R&D for a top five pharmaceutical company. Dr. Ng-Cashin earned her MD from Rush Medical College, trained in Internal Medicine at the University of Chicago, and received an infectious diseases and hematology fellowship training at the University of North Carolina.

• 

  Daniel O'Connor, DrMed, PhD, MS

  • Medical Assessor
  • Medicines and Healthcare products Regulatory Agency, United Kingdom

  Dan is a Leicester medical graduate with a background in cancer research, histopathology and oncology. His PhD in the field of tumour suppressor genes was awarded from Imperial College London and he holds an MSc in Oncology from the Institute of Cancer Research. He completed higher medical training in the UK in Pharmaceutical Medicine. He joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a Medical Assessor in 2006. He is editor author of the first edition Oxford Specialist Handbook of Pharmaceutical Medicine and he is on the editorial board of the journal Expert Opinion on Orphan Drugs. Dan has special interest in rare diseases, patient engagement and early access.

• 

  Minhaj Obeidullah, MSc

  • Head Compliance & Risk Management
  • Novartis, Switzerland

• 

  Handan Öztunca

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

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

• 

  Philippe Page, DrSc

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

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

• 

  Ilona Reischl, PhD, MPharm

  • Biologics Quality Assessor
  • Austrian Medicines and Medical Devices Agency (AGES MEA), Austria

  Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality assessor of biologics including Advanced Therapy Medicinal products and she is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies. Her regulatory expertise in Clinical Trials, Non-interventional studies, scientific advice and compassionate use procedures reflect a strong interest in the development of biological medicinal products.

• 

  Bita Rezaallah

  • Medical Safety Lead
  • Novartis Pharma AG, Switzerland

• 

  Smita Robinson

  • Director - Regulatory Labelling
  • Pfizer, United Kingdom

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

• 

  Linda Rutgrink

  • Regional Trial Manager
  • Sanofi, Netherlands

  Linda has a Master in Biomedical Sciences at the University of Leiden, the Netherlands. She started in the Clinical Study Unit of Sanofi in 1994, currently in a regional role. Being in Clinical Operations project management for over 25 years, Linda Rutgrink is an operational expert. She is involved in innovation initiatives. Currently she is deeply involved in the IMI consortium project called Trials@Home. She is also a member of a project team in Transcelerate to propose and develop ideas to Modernize Clinical Trial Conduct.

• 

  Vincenzo Salvatore, JD, PhD

  • Focus Team Leader Healthcare and Life Sciences
  • BonelliErede, Italy

  Former Head of the Legal Sector at the European Medicines Agency (November 2004-June 2012). PhD in European Law from the European University Institute of Florence (I), Full Professor of European Union Law, Member of the Editorial Board of European Pharmaceutical Law Review (published by Lexxion). Qualified Italian Lawyer ("Avvocato"). Leader of the Focus Team Healthcare and Life sciences at BonelliErede law firm, Milan (Italy). Author of several books addressing European Union law issues and a of a wide range of articles on European pharmaceutical law related matters.

• 

  Anja Schiel, PhD

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

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

• 

  Gabriele Schwarz, MPharm

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

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

• 

  Michael Shum

  • Therapeutic Goods Administration (TGA), Australia

• 

  Rose-Marie Swallow

  • Senior Manager, Policy & Research
  • Bayer Plc., United Kingdom

  Rose-Marie joined Bayer in July 2013 and is a Senior Manager in EU Regulatory Policy & Intelligence, with special responsibility for CTR implementation and Transparency within the Company. Rose-Marie came to Bayer with over 20 years EU regulatory experience in both the prescription and non-prescription healthcare sectors gained within a number of large research based Pharmaceutical Companies; as well as having worked as a Senior Regulatory Consultant in a small CRO. Rose-Marie has a BSc (1st class hons) in Chemistry and Biochemistry.

• 

  Fergus Sweeney, PhD

  • Head of Clinical Studies and Manufacturing Task Force
  • European Medicines Agency, Netherlands

  Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

• 

  Kjetil Tasken

  • Head of Institute, Professor
  • Institute For Cancer Research, Oslo University Hospital, Norway

• 

  Vivek Thakkar

  • Genentech, A Member of the Roche Group, United States

  Vivek Thakkar is a regulatory affairs professional with a Master’s Degree and 12 years of experience with Class II and Class III medical devices. Currently he is supporting Artificial Intelligence and Machine Learning (AI/ML) based Drug Development Tools and Software as a Medical Devices (SaMD) as a Regulatory Program Director for Digital Health products at Genentech/Roche Pharmaceuticals. Vivek has proven success in building/executing global regulatory strategies and hiring, training, & inspiring regulatory experts for medical device submissions.

• 

  Phil Tregunno

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

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

• 

  Griet Vangheel, MS

  • Head Quality Management at Bioresearch Quality and Compliance
  • Johnson & Johnson, Belgium

  Brings more than 30 years of diverse leadership experience in J&J Pharmaceuticals where she held positions of in Quality Control, Research & Development, Compliance, Quality Assurance Pharmaceuticals Operations, Manufacturing Operations and Commercial Quality. Currently leading a global team across the US, Asia and Europe to develop and optimize business processes , corresponding procedures and procedural documents and provide training that support company compliance objectives towards regulatory requirements, industry requirements and internal quality standards. The Quality Management group is core to the development of a strong Quality Management System (QMS) while partnering with Janssen R&D and to driving a quality culture.

• 

  Marco Viceconti

  • Professor, Department of Industrial Engineering, Alma Mater Studiorum
  • University of Bologna, Italy

  Marco Viceconti is full professor of Industrial Bioengineering in the department of Industrial Engineering of the Alma Mater Studiorum – University of Bologna, and Director of the Medical Technology Lab of the Rizzoli Orthopaedic Institute. In the IMI-funded Mobilise-D project, he serves as academic lead of the regulatory workpackage, which is pursuing the regulatory qualification of digital mobility outcomes from wearable sensors as drug development tools.

• 

  Christian Wetter, PhD

  • Senior Regulatory Portfolio Director
  • Roche, Switzerland

  Christian Wetter is an organic chemist and holds a Ph.D. from the University of Marburg. He started his professional career at Roche in 2004 in Chemical Development before moving to Novartis to Regulatory CMC in 2009. In 2020 he joined Roche again and currently acts as a Senior Regulatory Portfolio Director. Christian has worked on small molecule, peptide, oligonucleotide and device development projects in various phases of development and commercial lifecycle. He is part of the European Pharma Oligonucleotide Consortium (EPOC) and is currently leading its regulatory subteam.

• 

  Mona Ali AL Hammadi

  • Head of Conventional Medicines New Registration Unit
  • Ministry of Health and Prevention (MOHAP), United Arab Emirates

• 

  Nicola Bedlington

  • Special Advisor
  • European Patient's Forum, Belgium

  Nicola Bedlington is EPF’s Secretary General since September 2014 and was previously the Executive Director since the setting up of the EPF Secretariat in June 2006. She worked as an external expert for the European Commission on disability policy and NGO cooperation and was the first Director of the European Disability Forum during the 90s. More recently she led the ENSI Secretariat, an OECD initiated international governmental network on education and sustainable development. She has a BA (Honours) Degree Management Studies and French from the Metropolitan University Leeds (United Kingdom).

• 

  Christopher P Boone, PhD, MHA

  • Group Vice President, Research Services, Life Sciences
  • Oracle, United States

  Christopher Boone, PhD has a career-long history as a dynamic, innovative thought leader and a public voice on the power of real-world evidence, health informatics, and big data analytics and its ability to radically transform the global health care system into a learning health system. He is also an adjunct assistant professor of health administration at the New York University's Robert F. Wagner Graduate School of Public Service, an active board member of several influential organizations, and a co-founder of a few start-up companies.

• 

  Isabel Chicharo, MS

  • Head of Regulatory Data Management
  • European Medicines Agency, Netherlands

• 

  Emil Andrei Cochino, MD, MHS

  • Scientific Senior Specialist (Risk Management)
  • European Medicines Agency, Netherlands

  Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for Advanced Therapy Medicinal Products. Furthermore, he is overseeing the revision 3 update of GVP Module V – Risk Management Systems and is coordinating the Agency’s transparency efforts for RMPs.

• 

  Matthew Francis, PhD, MS

  • Global Safety Surveillance & Analysis
  • Procter & Gamble, Inc., United States

• 

  Ian Hudson

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

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

• 

  Greg Perry

  • Assistant Director General
  • IFPMA, Switzerland

• 

  Inger Torgersen, MSc

  • Global Regulatory Leader
  • Bayer Pharma AG, Germany

  Inger Torgersen is a biologist by training, with an MSc in physiology. She started her career in the pharmaceutical industry as a regulatory affairs manager in the imaging area more than 20 years ago, before transitioning to oncology in 2001. Since 2007 her focus has mainly been on development of radiopharmaceuticals, initially at Algeta ASA in Oslo, Norway (now part of Bayer), and since 2014 at Bayer AG, Germany, where she currently holds a position as Global Regulatory Leader within oncology regulatory affairs strategy, with responsibility for the regulatory strategies for several targeted radionuclide therapy projects.

• 

  Marc Van Den Bulcke

  • Head of Cancer Centre at Sciensano
  • Sciensano, Belgium

• 

  Eleonora Agricola, PhD

  • Scientific Officer
  • Italian Medicines Agency (AIFA), Italy

  Eleonora Agricola is a molecular biologist by training and obtained her PhD in Life Science at La Sapienza University of Rome. After a postdoc research fellowship at Cancer Research UK in the field of epigenetic and cancer, she moved to Rome starting a career in digital health communication and innovation in pediatrics. In 2017, she moved to the Italian Medicines Agency (AIFA) in the Director General's scientific staff and since 2019 is scientific officer at AIFA's Innovation Office. She is member of EMA-HMA European Innovation Network and EMA-HMA Big Data Steering Group. She is AIFA’s expert for the ICMRA Network for Innovation.

• 

  Nada Alkhayat

  • Policy Officer, Medical Devices
  • European Commission , Belgium

• 

  Ib Alstrup

  • Medicine Inspector
  • Danish Medicines Agency , Denmark

  Ib Alstrup is a Medicines Inspector, GxP IT, with the Danish Medicines Agency and an EMA expert. With a background as a SW, tester and IT QA from the industry; he has specific focus on inspection of regulated parties’ validation and safe operation of computerised systems throughout all GxP areas.

• 

  Ralph Bax, MD, PhD

  • Head of the Paediatric Medicines Office
  • European Medicines Agency, Netherlands

  After studying medicine and health care management in Germany, Dr Ralph Bax completed his training as a paediatrician at the Children’s University Hospital in Munich/Germany. There he specialised in neonatology and led the department of developmental neurology. In 2007 he joined the paediatric team at the European Medicines Agency in London supporting the Paediatric Committee (PDCO) in the area of neonatology, neurology and child psychiatry and working on public health issues such as paediatric needs for medicines within the international co-operation with WHO and the International Neonatal Consortium. Dr Bax is the contact point for neonatology and since 2017 Head of the Paediatric Medicines office at EMA.

• 

  Antje Behring, PharmD, PhD

  • Head, Early Benefit Assessment, Pharmaceuticals Department
  • Federal Joint Committee (G-BA), Germany

  Antje Behring is a pharmacist, working for the G-BA since 2011. She is team lead of the team “early benefit assessment” in the G-BA Pharmaceuticals Division. Before joining the G-BA, Antje worked as a consultant pharmacist for a health insurance company. Prior to working in the pharmaceutical area, she worked as a physical therapist in hospitals and outpatient offices.

• 

  Nihan Burul Bozkurt, PhD

  • Health Policies Director
  • AIFD, Turkey

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

• 

  Ivo Claassen, PhD, MSc

  • Deputy Executive Director and Head of Veterinary Medicines Division
  • European Medicines Agency, Netherlands

  Dr Ivo Claassen is head of the Veterinary Medicines Division and Deputy Executive Director at the European Medicines Agency. Since he joined the Agency in 2018, he has been responsible for the implementation of Veterinary medicinal products regulation EU 2019/6 which has as one of its objectives to reduce the risk of veterinary antimicrobial use. Furthermore, he was involved in the development of the Veterinary Regulatory Science Strategy and the EMA Veterinary Big Data strategy. He has also over 30 years of experience in vaccine production, QC/QA, R&D and regulatory affairs, both for human and veterinary vaccines.

• 

  Helena Corte-Real Correia, PhD

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

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

• 

  Rosalie M. Cull

  • Chief Executive Officer
  • Adjutor Healthcare Pty Ltd, Australia

• 

  Ton de Boer, MD

  • Chairman Medicines Evaluation Board
  • MEB, Netherlands

  Prof. Anthonius de Boer, MD, PhD was trained in Internal Medicine followed by a PhD in clinical pharmacology. In 1990 he was appointed as assistant professor in Clinical Epidemiology followed by an associate professorship of pharmacotherapy. In 1994 he bacame Epidemiologist and in 1996 Clinical Pharmacologist. In 2001 he bacame professor of pharmacotherapy and director of the Pharmacy School. From 2007-2015 he was the head of the Department of Pharmaceutical Sciences, Utrecht University, Fom 2002-2014 he was a member of the Central Ethics Committee of the Netherlands and from 2014-2017 he was the chairman of the Drug Committee of the National Health Care Institute. From 2017 he is the Chairman of the Medicines Evaluation Board of the NL.

• 

  Evelien De Sutter, MPharm

  • PhD researcher
  • KU Leuven, Belgium

  Evelien De Sutter is currently pursuing a PhD in Pharmaceutical Sciences at KU Leuven (Belgium). Her research focuses on informing a participant-centric electronic informed consent application in clinical research. Evelien holds a Master of Science in Drug Development (2017) and in Industrial Pharmacy (2018), obtained at the University of Ghent (Belgium).

• 

  Katherine Donegan

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

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

• 

  Maria Elgaard Sørensen

  • Special advisor
  • Danish Medicines Agency, Denmark

  Maria Elgaard is a special adviser and project manager at the Danish Medicines Agency and currently in an interim position as team manager in the CT unit. Educational background is M.SC.Pharm and she has been working as an assessor of clinical trials application for several years. As of 2016 she has been increasingly engaged in the CTIS project currently as MSPO and master trainer. Nationally she has been appointed business specialist in both the European and the Danish IT solutions for handling clinical trials and other national systems with interaction to the clinical trials area.

• 

  Susan Forda, PhD

  • VP, GLobal Regulatory Affairs International
  • Eli Lilly & Company Ltd., United Kingdom

  Sue is a PhD pharmacist. After university she joined SmithKline Beecham Pharmaceuticals followed by Eli Lilly and now is VP for International regulatory affairs. She is currently Chair of the EFPIA “Adaptive Models Priority Working Group”.

• 

  Julia Frese, MBA

  • Department Manager Centre of Combination Products
  • TÜV SÜD , Germany

  By education biomedical engineer with a Master degree in business administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was further involved in the development of standards for ATMP products. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organisation. She is further co-chair of the Team NB working group for article 117.

• 

  Markus Goese

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

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

• 

  Hilmar Hamann, PhD

  • Head of Information Management
  • European Medicines Agency, Netherlands

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

• 

  Milou Hogervorst, PharmD, MSc

  • PhD Candidate
  • Utrecht University, Netherlands

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

• 

  François Houyez

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

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

• 

  Gordon Kessler, JD, MBA

  • General Counsel, Chief Administrative Officer
  • AiCure, United States

  Gordon Kessler is a founder, Chief Administrative Officer, and General Counsel at AiCure, managing the legal, intellectual property, regulatory, and quality functions. Gordon has extensive experience with data privacy and other regulatory topics, is registered to practice before The United States Patent and Trademark Office, and has extensive experience preparing patent applications, infringement and invalidity opinions, and advising on corporate transactions. Gordon holds a Bachelor’s degree in Systems Engineering from the Moore School of Engineering and a Master’s of Business Administration from the Wharton School, both at the University of Pennsylvania. Gordon also received his Juris Doctor degree from Duke University School of Law.

• 

  Jessica Liu, MD

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

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

• 

  Viola Macolic Sarinic, DrSc, MD, MSc

  • PRAC Scientific Lead
  • European Medicines Agency, Netherlands

  Viola Macolic Sarinic is a medical doctor, clinical pharmacologist by specialisation who holds a PhD in Pharmacogenomics applied to Biosciences and a master’s in Clinical pharmacology (pharmacokinetics). More than 20 years’ experience as a clinical pharmacologist and pharmacovigilance specialist, both in university hospital and in the medicines regulatory authority in Croatia working at the positions of a clinical and pharmacovigilance assessor, head of the PV department, national PRAC and CHMP member at the European medicines agency (EMA) and served for four years as the director of the Croatian medicines agency (HALMED). Currently at EMA as the PRAC Scientific Committee Lead and Scientific adviser on safety of medicines in the PV office.

• 

  Marie Manley

  • Partner, Head of EU and UK Life Sciences (UK)
  • Sidley Austin LLP, United Kingdom

  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.

• 

  Christopher McCabe

  • Executive Director & CEO
  • Institute of Health Economics, Canada

  Dr. Christopher McCabe is the Executive Director and CEO of the Institute of Health Economics (IHE).He is a Professor of Health Economics at the University of Alberta, and served as Professor of Health Economics a the Universities of Sheffield, Warwick and Leeds in the UK. From 2011-2017, Dr. McCabe held a the Capital Health Research Chair at the University of Alberta. From 2007-2011 he was Founding Director of the Academic Unit of Health Economics at the Leeds Institute of Health Science.

• 

  Sylvie Meillerais, MSc

  • Director Global CMC Policy
  • MSD Belgium, Belgium

  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.

• 

  Lorraine Nolan, PhD

  • Chief Executive
  • Health Products Regulatory Authority , Ireland

  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.

• 

  Frederik Grell Nørgaard

  • Project Manager
  • Danish Medicines Agency, Denmark

• 

  Louise Place

  • Director, Devices
  • GSK, United Kingdom

  Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions. Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio. With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

• 

  Kamilla Posselt

  • Senior DCT Strategy and Innovation Director Digital & Decentralized Solutions
  • PPD, part of Thermo Fisher Scientific, Denmark

• 

  Lynn Rochester

  • Translational and Clinical Research Institute, Faculty of Medical Sciences
  • Newcastle University, United Kingdom

• 

  Elizabeth Sapey

  • University Hospitals Birmingham NHS Foundation Trust, United Kingdom

  Pr Elizabeth Sapey is an Academic Acute Medicine and Respiratory Physician at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. She is Director of the HDR-UK Health Data Research Hub in Acute Care, PIONEER, and Director of the Institute of Inflammation and Ageing. Having completed a PhD in neutrophil biology in 2012, Liz’s research focus on inflammatory diseases associated with ageing, and the impact of inflammation in an ageing host during unplanned admissions to hospital. Her interests span translational science, moving new or repurposed therapies into early phase clinical trials and using routinely collected health data to inform health challenges and their solutions.

• 

  Helen Shaw

  • Chief Medical Officer
  • PROVECA- Medicines for Children, United Kingdom

• 

  Hiiti Sillo, MSc, RPh

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

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

• 

  Kenichi Tamiya, MSc, RPh

  • Associate Executive Director, Office of New Drug
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  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.

• 

  Marie Valentin, PharmD

  • Team Lead, Facilitated Product Introduction
  • WHO, Switzerland

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

• 

  Jan Van Parijs

  • R&D Quality CT&S, Head Quality Solutions
  • Bristol Myers Squibb, Belgium

• 

  Tessa I. Van Rijssel, MA

  • PhD candidate
  • UMC Utrecht, Netherlands

  I am a PhD candidate at the Julius Center for Health Sciences and Primary Care of the University Medical Center Utrecht (UMCU), focussing on the topic of medical research ethics and decentralized clinical trials. I have a background in philosophy of science and the social sciences.

• 

  Tobias Wiesenthal

  • Head of Sector Research and Innovation Sector , Unit eHealth, Well-Being and Age
  • DG CONNECT, European Commission, Belgium

• 

  Jie Zhan

  • Novartis , Switzerland

• 

  Shereen Abdel-Gaward

  • Head of Central Administration of Pharmaceutical Care
  • Egyptian Ministry of Health and Population, Egypt

• 

  Szymon Bielecki

  • DG CONNECT, Unit H3 eHealth, Well-being and Ageing
  • European Commission, Belgium

• 

  Erik Briers

  • Vice Chair
  • EUROPA UOMO, Belgium

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

• 

  Jasper-Hugo Brouwers

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

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

• 

  Marianne Cunnington

  • GlaxoSmithKline, United Kingdom

• 

  Mariette Driessens, PhD

  • Stichting HemoNED and VSOP
  • VSOP – Patient Alliance For Rare and Genetic Diseases, Netherlands

  Mariette Driessens is policy officer at VSOP - Patient Alliance for Rare and Genetic Diseases and the haemophilia patient society NVHP, in the Netherlands. As former patient representative of the Committee for Advanced Therapies, she is stimulating patient engagement in application of innovative genetic therapies in the clinic. Mariette is currently a member of the Round table on Orphan Drugs at the Dutch HTA agency (Zorginstituut). As board member of HemoNED, the Dutch registry of hemophila and other bleeding disorders she has expertise in representing the patient perspective in the governance of a registry.

• 

  Jan Geissler, MBA

  • Managing Director
  • Patvocates, Germany

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

• 

  Sharon L Gorman

  • Pfizer, Inc., United Kingdom

  Prior to and since joining Pfizer in 2004, Sharon was Global Regulatory Lead in the Allergy and Respiratory therapeutic area. She has a BSc in Applied Biology from University of Hertfordshire and started her regulatory career in a veterinary supply company in 1991. In 1992 she joined The Wellcome Foundation working in International Regulatory Affairs. From 1993 to 1998 she worked at Fisons Pharmaceuticals and Norton Healthcare in the Allergy and Respiratory area, before joining GlaxoWellcome in 1998. She held various regulatory positions at GlaxoWellcome and GlaxosmithKline but returned to Allergy and Respiratory area in 2003.During this time she studied the BIRA/University of Cardiff Diploma in Regulatory Affairs, graduating in 2000.

• 

  Jennifer Harris

  • Director of Research Policy
  • The Association of the British Pharmaceutical Industry (ABPI), United Kingdom

  Dr Jennifer Harris is the Director of Research Policy at the Association of the British Pharmaceutical Industry (ABPI) in the UK, where she leads on making the UK a world-leading environment to conduct pharmaceutical research and development. She has worked at ABPI for over 3 years, previously leading on clinical research policy, including how we embed patient and public involvement and champion diversity and inclusion in research. Previously, she worked at the UK Government’s Department of Health and Social Care on the Independent Review of the Mental Health Act. She has a PhD in medical research from the University of Cambridge, where she worked on the role of dendritic cell immunity in early stage melanoma.

• 

  Jesper Kjær, MS

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

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

• 

  Nathalie Moll

  • Director General
  • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

  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.

• 

  Georg Neuwirther, MS, MSc

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

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

• 

  Aleksandra Opalska

  • Policy Officer
  • European Commission - DG SANTE, Belgium

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

• 

  Karen Samuels

  • Programme Director AWTTC
  • AWTTC, United Kingdom

• 

  Violeta Stoyanova-Beninska, MD, PhD, MPH

  • Chair COMP EMA, Chair Scientific and Regulatory Advice MEB
  • Medicines Evaluation Board, Netherlands

  Dr. Violeta Stoyanova-Beninska is Chair of the Committee for Orphan Medicinal Products at the European Medicines Agency since 2018. Before that she was a member of the COMP and Chair of the National Scientific and Regulatory Advice at the Medicines Evaluation Board. Violeta is supervisor of PhD students and guest lecturer at several universities. She is also member of scientific and advisory boards of international projects related to rare diseases, personalized medicine and orphan drug development.

• 

  Mats Welin, MPharm

  • Senior Expert
  • Medical Products Agency (MPA), Sweden

  Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics and normative work within this field. Since 1996 I am the Swedish delegate of the Biologics working party (BWP) and have been a member of the EMA group involved in classification of variations for many years. I am a member of EMEA PAT team and was also a delegate of the Q-IWG of the ICH during its existence to work with introduction of the Q8-Q10 concepts.

• 

  Junaid Bajwa, MD, MBA, MSc, FRCP

  • Senior Partner, Head of UK, and Science Partner, Pioneering Intelligence
  • Pioneering Intelligence, United Kingdom

  Junaid is a Senior Partner at Flagship Pioneering, where he leads the UK, and serves as a Science Partner for Pioneering Intelligence globally. He is also a practising physician in the UK’s National Health Service. Previously, he was the Chief Medical Scientist at Microsoft Research, focusing on how trusted, reliable, and human-centered AI can transform the practice of medicine. In this role, he led a number of strategic partnerships with leading health and life sciences organizations and spearheaded Responsible AI initiatives in the sector. Academically, Junaid is a Clinical Associate Professor at University College London (UCL), a Visiting Scientist at the Harvard School of Public Health, and Visiting Scientist at the NTU in Singapore.

• 

  Lisbeth Bregnhoj, PhD, MPharm

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

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

• 

  Tim Chesworth

  • Senior Director Regulatory Affairs
  • AstraZeneca, United Kingdom

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

• 

  Catherine Chronaki, MSc, PMP

  • Secretary General
  • HL7 Europe Foundation, Belgium

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

• 

  John Concato, MD, MPH, MS

  • Associate Director for Real-World Evidence Analytics, OMP, CDER
  • FDA, United States

  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.

• 

  Fabio D’Atri

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

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

• 

  Monica Dias, PharmD, PhD, MPharm, RPh

  • Head of Supply and Availability of Medicines and Devices, a.i.
  • European Medicines Agency, Netherlands

  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.

• 

  Louise C. Druedahl, PhD, MPharm

  • Faculty of Law
  • Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Denmark

  Louise C. Druedahl, PhD, MPharm, is currently a PostDoc at the University of Copenhagen and her research lies in the intersection between law and science. Louise's ongoing work include investigations of AI use for drugs and drug development as well as of regulatory and legal incentives for knowledge-sharing in biologics R&D to increase innovation.

• 

  Viola Savy Dsouza, MSc

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

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

• 

  Gul Erdemli, MD, PhD

  • Global Program Regulatory Director
  • Novartis Pharmaceuticals Corporation, United States

  Gül Erdemli is a Global Program Regulatory Director at Novartis Regulatory Affairs Early Development. She is a drug development leader with more than 15 years industry experience from target identification to clinical development. She has an MD degree from Hacettepe University, Medical School in Ankara, Turkey and a PhD in Pharmacology from the same university. She a Diplomate of American Board of Toxicology (DABT) and holds Regulatory Affairs Certifications (RAC) for US and EU. She has experience in small molecule, biologics and gene therapy clinical development as well as development of novel digital outcome assessments. She has provided global strategic and operational regulatory direction for two international consortiums funded by In

• 

  Marie Helene Fandel

  • Senior Director
  • Sanofi, Belgium

• 

  Dominique Hamerlijnck, MBA

  • Patient Expert
  • Atini, Netherlands

  Dominique Hamerlijnck has a Masters in Philosophy, specialised in ethics and a Masters in Business Administration. Dominique is one of the European Patients’ Academy on Therapeutic Innovation (EUPATI) fellows. Next to her professional life for the past 25 years Dominique is also working as a patient expert especially in the field of severe asthma. She has been involved in many Dutch and EU projects in a patient advisory capacity. She is the patient co-chair for a European Respiratory Society Clinical Research Cooperation on severe asthma. She is a member different patient advisory groups and has been successful in getting the patient voice heard in health technology development.

• 

  Rosanne Janssens, DrSc, MSc

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

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

• 

  Andrew Lennard, PhD, MS

  • Regulatory Affairs CMC
  • Amgen, United Kingdom

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

• 

  Elspeth McIntosh, MBA, RN

  • Director
  • Castle Pharmacovigilance Ltd, United Kingdom

  Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

• 

  Claas Röhl

  • chair
  • NF Kinder – Verein Zur Förderung Der Neurofibromatoseforschung Österreich, Austria

  After the diagnosis of his daughter with Neurofibromatosis Type 1, a rare genetic tumor risk syndrom, Claas Röhl began his path into patient advocacy. He founded the Austrian patient organization NF Kinder in Dec 2013. He completed several educational programs for patient representatives (such as the EUPATI, EURORDIS summer school & winterschool), NF Kinder managed to establish the first Austrian center of expertise for NF in Austria by forming a partnership with the Medical University of Vienna. On a European level Claas Röhl co-founded NF Patients United, a European umbrella organization for NF patient organizations.

• 

  Malin Skogsberg

  • Head, Regulatory Process and Compliance
  • AstraZeneca, Sweden

  Experienced Regulatory professional and leader, with +15y in the pharmaceutical industry. Currently heading up team of 20 (across 4 countries), focused on Regulatory Process, Quality Mgt/Compliance and Learning activities for Regulatory R&D and market level groups. Experience of projects in late stage, Marketing Application and post-approval phases in primarily Cardiovascular area. Skilled in leading people and projects, Master of Science in Pharmacy & Pharmaceutical Chemistry from Uppsala University.

• 

  Meredith Smith, PhD, MPA, FISPE

  • Senior Director, Implementation Science Pillar Lead
  • Evidera, Inc, United States

  Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.

• 

  Beata Stepniewska, MPharm

  • Deputy Director , Head of Regulatory Affairs
  • Medicines for Europe, Belgium

  B.Stepniewska after an academic career at the Fac. of Pharmacy as Head of the Dep. of Pharm. Law and Pharmacoeconomics, joined the industry as Head of the Regulatory Dep for PLIVA Krakow. She has now been with the European Generic medicines Association (now Medicines for Europe) since 2002 as Director of Regulatory Affairs, and since 2013- Deputy Director General

• 

  Valentina Strammiello, MA

  • Director of Programmes
  • European Patients' Forum, Belgium

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

• 

  Ghislaine Van Thiel, PhD, MSc

  • Ass. Professor Medical ethics
  • University Medical Center Utrecht, Netherlands

  Ghislaine van Thiel studied Health Sciences and specialized in Medical Ethics and Philosophy of Science. Currently she is Associate Professor Medical Ethics at the Julius Center of the University Medical Center Utrecht (UMCU). Her main research topics are ethics of drug regulation and development, and clinical ethics. Ghislaine is a member of the Dutch Health Council and chair of the Medical Research Ethics Committee METC Utrecht.

• 

  Julie Williams, PhD

  • Expert Assessor
  • MHRA, United Kingdom

  She has worked in pharmacovigilance for almost 17 years having the joined the then Medicines Control Agency in 1998. Following realignment and formation of the MHRA she became a Unit Manager within the Risk Management Group and held that role until September 2013. She has been actively involved in providing expert advice to the UK representative at the Council Working Group influencing the UK’s position at the negotiations on the EU Pharmacovigilance legislation and more recently involved in work on transposition of the EU Directive into national legislation. Since September 2012 she has been the UK delegate of the EU PRAC and been actively involved in the work of the committee.

• 

  Angelique Winzenrieth

  • Vice President International Regulatory Affairs
  • PTC Therapeutics, France

  Angelique Winzenrieth is currently VP International Regulatory Affairs (ex-US) at PTC Therapeutics. Previously Head of EMEA Regulatory Affairs at Aegerion Pharmaceuticals, where she was key in the registration of Lojuxta in Europe. From 1998-2011, she held several positions in Regulatory Affairs at Quintiles in the EU. During which she was also a part-time teacher in Regulatory Affairs at the Univ. of Pharmacy in Strasbourg. Prior, was the EU Regulatory Affairs representative at Genetics Institute, where she managed the registration of her first orphan biotechnology product, BeneFIX. She holds a PharmD from the Univ.of Strasbourg and recently participated in a Harvard Business School Program, preparing to become a Corporate Director.

• 

  Ahmed M HUSSEIN Babiker, MSc, RPh

  • Head, Drug Registration & Pricing Section
  • Ministry of Public Health, Qatar

  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.

• 

  Peter Bachmann

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

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

• 

  Sean Barry, PhD

  • Senior Pharmaceutical Assessor
  • Health Products Regulatory Authority (HPRA), Ireland

  Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals Working Party (BWP) at EMA and regulatory chair the ICH Quality Discussion Group. He has helped draft several guidelines such as the EMA toolbox guidance for PRIME products, the EMA reflection paper on statistical methodology, and the EMA-FDA Q&A on regulatory flexibilities. As a member of the ICMRA collaborative assessment group, Sean helped establish the first pilot programme for multi-agency assessment of post-approval CMC changes.

• 

  Sigita Burokiene

  • Italy

  Sigita Burokiene, MD, MPH, PHD is consultant paediatrician at Vilnius University Hospital Santaros Klinikos, associate professor at Vilnius University Faculty of Medicine. Since 2017 to 2020 she was appointed as a national delegate to scientific paediatric committee (PDCO) at European Medicines Agency. Research areas of interest: paediatric emergency medicine, antibiotic prescribing and stewardship. She is involved in paediatric research studies, including ARPEC, GLOBAL-PPS, PED-MERMAIDS, supervised undergraduated medical students and trainees, publishes scientific articles in peer-reviewed journals, presents topics at the National and International conferences.

• 

  Vittoria Carraro

  • Government Affairs Associate Director
  • European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium

  Associate Director for Government Affairs at EUCOPE, Europe’s trade body for small to medium-sized innovative companies working in the field of pharmaceuticals and medical technologies. Ms Carraro leads EUCOPE’s work on pharmaceutical incentives and rare diseases. She has been working on innovation and health policies through her accumulated professional experience including with the European Commission (DG Sante), national and regional governmental institutions, non-profit organisations and a global consultancy firm. She was a Member of the Committee on Data for Healthy Societies of the European Health Parliament from 2018-2019 and currently, she is part of the multistakeholder group the European Expert Group on Orphan Drugs Incentives.

• 

  Ansgar Hebborn, PhD, MBA

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

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

• 

  Sarah Mee

  • Medical assessor
  • MHRA , United Kingdom

• 

  Hélène Negre

  • Servier and IMI T2EVOLVE Project Leader, France

• 

  Susanne Norskov, MPharm

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

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

• 

  Michal Rataj

  • European Alliance of Neuromuscular Disorders
  • European Patients’ Forum, Slovenia

• 

  Christos Sotirelis

  • Member of the ILAP Patient and Public Reference Group, United Kingdom

• 

  Rebecca A. Vermeulen, RPh

  • Vice President, Global Patient Networks | PD Medical Affairs
  • Genentech, A Member of the Roche Group, United States

  Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons, Patient Partnership, Digital Health, and Six Sigma, in her 29 years of healthcare industry experience, and has been responsible for creating global standards for information exchange with healthcare professionals and patients. Rebecca is currently a board member for Patient Focused Medicines Development, Past Chair Board of Directors for the DIA, Chair Emeritus Corporate Board of Directors for the Healthcare Businesswomen’s Association.

• 

  Martina von Meyenn

  • Global Medical Chapter Lead Real World Evidence
  • F. Hoffmann-La Roche, Switzerland

  Dr. Martina von Meyenn leads the Global Medical Real World Data (RWD) Chapter at F. Hoffmann La-Roche. In her role she focuses on providing strategic guidance on the most meaningful use of RWD for clinicians and patients at the point of care, with a long term view to be future proof in an evolving healthcare ecosystem. Martina is passionate about realizing the value that RWD can bring to healthcare systems and frequently engages in policy discussions and other multi-stakeholder consortia in an effort to share learnings from innovative RWD solutions and help the ideation process around ways to overcome current challenges with a view to enable future proof efforts that create a positive impact and meet stakeholder needs.

• 

  Julia Claus

  • CMC Regulatory
  • Pfizer, United Kingdom

  Julia Claus has 30 years’ experience within the industry initially within analytical development in GSK, and currently within CMC regulatory at Pfizer. Her portfolio has covered the full development cycle, from first in human studies, through marketing applications and into post-approval changes. Julia currently leads an EFPIA sub-team focussing on small molecule stability topics, with a particular focus on enhancing understanding and ultimately acceptability of predictive and accelerated techniques, as well as contributing to EFPIA’s position on the refresh of the ICH stability guidelines.

• 

  Doug Danison

  • SVP, Head of Europe
  • Bluebird Bio, United States

  Doug Danison joined bluebird bio in July 2015 charged with establishing the global pricing, market access, and health economics team known as Access Value & Evidence Strategy (AVES). Doug transitioned to Head of Europe in 2021 and is currently leading some of the commercial strategy work to prepare for launch in the US. Doug has more than 20 years of industry experience including roles with Eli Lilly & Company, Amgen, Millennium/Takeda Oncology. He has led or overseen the preparation of market access strategies for products in early development, pivotal study planning, launch, and post launch lifecycle management. Doug has addressed increasingly challenging market access challenges in Global, European and US roles.

• 

  Amos De Jong, MSc

  • PhD candidate
  • Utrecht University, Netherlands

  Amos de Jong is a PhD student at the Utrecht University, the Netherlands. His thesis work focuses on the regulatory aspects of clinical trial innovation, in particular regarding decentralized clinical trials. The work is embedded within the Innovative Medicines Initiative Trials@Home consortium. Amos completed a BSc and MSc in Biomedical Sciences from the VU University Amsterdam.

• 

  Jacques Demotes, MD, PhD

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

• 

  Rebecca Ellston

  • Associate Director, Regulatory Business Development
  • AstraZeneca, United Kingdom

  For the past five years I have worked in the Regulatory Business Development Group in AstraZeneca, leading the regulatory transfer of product licences into and out of AZ. Pre-deal our group prepares data rooms and creates the regulatory transfer strategy. Before this my regulatory experience was with the International markets, preparing new licence applications. Regulatory was a career change after working for over 20 years in Oncology Bioscience Research on many pre-development projects, following a degree in Genetics.

• 

  Sini Eskola, MPharm, MS, MSc

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

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

• 

  Marc-André Giguère

  • Senior Policy Analyst
  • Health Canada, Canada

• 

  Adam David Kammler

  • Senior Manager, GPV CBM Compliance & Analytics
  • Otsuka Pharmaceutical Development & Commercialization, Inc, United States

• 

  Thomas Metcalfe, MBA

  • Personalised Healthcare Ecosystems
  • F. Hoffmann-La Roche, Switzerland

  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.

• 

  Sarah Montagne

  • Head UK/IE Regulatory Affairs
  • Bayer plc, United Kingdom

  Sarah Montagne holds a Bachelor of Science 2(1) Degree in Toxicology and Law. In her current position she is responsible for addressing EU regulatory policy topics impacting on the Company and taking operational responsibility for the UK regulatory team based in Reading, UK. Using both of her roles she is responsible for meeting operational regulatory goals, advising on regulatory challenges and developing advocacy strategies and policies. Brexit sits at the centre of current focus.

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  Angela Power

  • Data Governance, Ethics & Privacy Partner
  • Change Agency, Canada

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  Elise Schoefs, MSc

  • PhD student
  • KU Leuven, Belgium

  Elise Schoefs is a doctoral researcher at the KU Leuven in Belgium, in the Regulatory Sciences & Pharmaco-Economics research unit. Her research interests and activities focus on patient preferences and how these can be integrated across the medicinal product life cycle. Elise’s PhD research focuses on integrating shared decision making (SDM) in Belgian clinical practice. During her PhD, she will provide a supportive framework consisting of evidence-based, science-driven, and implementable policy recommendations for relevant stakeholders and new incentive models to increase the implementation of SDM in the Belgian healthcare system. In addition, she will investigate the economic added value of SDM in Belgian clinical practice.

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  Eva-Maria Stegemann

  • Health Ministry of Saxony , Germany

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  Annette Bakker, PhD

  • President and Chair of the board
  • Children's Tumor Foundation and CTF Europe, United States

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  Sally Darby

  • Patient Advocate, United Kingdom

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  Blanka Hirschlerova, MSc

  • Senior Pharmaceutical Assessor
  • State Institute for Drug Control, Czech Republic

  Currently Head of the Department of Pharmaceutical Assessment of Chemical & Herbal Drugs. She studied at the Faculty of Chemical Engineering of the Institute of Chemical Technology, specializing in Analytical and Physical Chemistry. Blanka is chairing the CHMP/CVMP Quality Working Party, has been actively participating in QWP for many topics. She is also a co-opted member for quality issues at CHMP. She participated on several ICH topics as EU representative, since 2005 on Q8 (Pharmaceutical development) and then further on an addendum of Q8, in 2011 on the final work on Q11 (Pharmaceutical development of active substance) and during 2014 and 2016 CTD-Q/M4Q (revision of CTD granularity document) and recently she is participating in ICH QDG.

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  Petr Horák

  • European Association of Hospital Pharmacists, Belgium

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  Charlie Mortazavi, PharmD

  • Global Regulatory Affairs – Senior Manager
  • SANOFI, France

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  Tuba Nihan Doruk

  • Associate Director, Global Pharmacovigilance Compliance and Business Management
  • Otsuka Pharmaceutical Europe Ltd., United Kingdom

• 

  Inaki Gutierrez-Ibarluzea

  • Director of organizational innovation and management
  • BIOEF, Spain

• 

  Anna Hallersten, MSc

  • Head Regulatory Policy Europe
  • Roche Diagnostics, Switzerland

  Anna Hallersten is Head Regulatory Policy Europe at Roche Diagnostics International (2017-present). Previously Director Public Affairs at SFL Regulatory Affairs & Scientific Communications (2010-2017) and International Public Policy Manager for Virology at F. Hoffmann-La Roche (2007-2010). From 2004-2007 she held positions at Fleishman Hillard International Communications, European Commission, Swedish Board of Agriculture. She holds a MSc. in Commercial and EU Law from Jönköping International Business School and is Roche’s representative to the Regulatory Affairs Committee at MedTech Europe.

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  David Mukanga, PhD, MPH

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

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

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  Brianne Peters, MBA, MSN, RN

  • Sr. Director of Nursing Solutions
  • Science 37, United States

  Brianne Peters, Director, Nursing Solutions, is responsible for the development, operations oversight, and daily management of all nursing activities within Science 37. This includes but not limited to managing nursing solutions managers, mobile nurses vendors, and contracted health care workers; operationalization of study protocols; development of necessary infrastructure to ensure streamlined and scalable processes within the department. Also responsible for overseeing clinical processes, developing, and delivering clinical education and training, ensuring study participant safety, appropriate scheduling, resource allocation, ensuring high quality of care and excellent brand representation.

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  Michael Sauter

  • Senior Director, Global Regulatory Operations
  • Alexion Pharmaceuticals, Inc., United States

  Michael Sauter has spent more than 25 years working in the pharmaceutical industry at leading companies located in both the US and Switzerland. He has worked in management and executive management roles that have included Chemistry, IT, and Regulatory Affairs, and R&D technology solutions. Michael spent almost 15 years leading Biogen's the Global Regulatory Operations, Project & Information Management functions, and finally as Senior Director, Digital Health Technologies Office at Biogen, he was participating in the formation and implementation of the Biogen Digital Health and Analytics Strategies. Michael is the Global Head of Regulatory Operations at Alexion, The rare disease business unit at AstraZeneca.

• 

  Jacquelyn Awigena-Cook, MSc

  • Director, Global Regulatory Policy & Intelligence
  • Bristol Myers Squibb, United Kingdom

  As Associate Director of Regulatory Policy and Intelligence at BMS, Jacquelyn is responsible for evaluating trends in the regulatory environment and working with stakeholders to advocate for policies supporting development of innovative medicines. She has been managing projects, leading initiatives, and designing processes to assess the impact of regulatory change on strategy, operations, and compliance in the pharmaceutical industry for 13+ years. Her current focus is on regulatory policies impacting ATMPs and supporting project teams in the Hematology & Oncology disease areas. Jacquelyn holds a degree in Cell Biology & Biochemistry from Bucknell University and a MSc from the London School of Economics and Political Science.

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  Sean Curtis, MD, MPH

  • Senior Vice President, Global Regulatory Affairs and Clinical Safety
  • MSD, United States

  Sean Curtis heads Global Regulatory Affairs & Clinical Safety at Merck, driving innovative regulatory and safety strategies to enable rapid and efficient licensure pathways and maintain product registration. Previously, he worked over 20 years in Clinical Development; most recently as the Late Stage Clinical Therapeutic Area Head for Respiratory & Immunology. From 2015-2020, he also led the Global Center for Scientific Affairs. Sean received his MD/MPH from Tufts University School of Medicine, completed an internship and residency in Internal Medicine at the University of Colorado Health Sciences Center, and a post-doctoral clinical and research fellowship in the Division of Infectious Diseases at Columbia Presbyterian Medical Center.

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  Julian Isla, MS

  • Director
  • Foundation 29, Spain

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

• 

  Hubert Leufkens, PharmD, PhD

  • Emeritus Professor of Pharmaceutical Policy and Regulatory Science
  • Utrecht University, Netherlands

  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.

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  Álmath Spooner, PhD

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

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

• 

  Gediminas Guntarskis, MPH

  • Scientific Data Organization Analyst
  • Parexel, Lithuania

  Analyst in Scientific Data Organization at Parexel with more than 7 years of experience in clinical research industry, including cross-border Risk Based Monitoring activities using "Transcelerate" defined methodologies as well as clinical site management activities. Prior to joining Parexel was actively involved in nation-wide public health technology assessments and acting as chief specialist, responsible for public health safety related issues and regulatory aspects.

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  Robbe Saesen

  • PhD Researcher
  • KU Leuven, Belgium

  Robbe Saesen is currently pursuing a PhD in Pharmaceutical Sciences at KU Leuven in Belgium. He also works as a Research Fellow at the European Organisation for Research and Treatment of Cancer (EORTC), which is headquartered in Brussels. His work mainly focuses on finding potential strategies to address the evidence gaps that remain after new anticancer therapies are approved by the regulatory authorities.

• 

  Nicholas Brooke, MBA

  • Executive Director, Patient Focused Medicines Development (PFMD)
  • PFMD, Belgium

  Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also helps individual organizations to build the capacity and capability to better engage with key stakeholders in partnerships to solve societal issues. Bringing his Synergist and caregiver hats together, he is the Executive Director of PFMD.org, a pre-competitive multi-stakeholder global collaborative platform dedicated to stimulating innovation in medicine and device lifecycles, digital health, and health system through systematic patient engagement, WITH patients

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  Paul Tanui

  • Senior Program Officer
  • AUDA-NEPAD, South Africa

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  Tiago Villanueva

  • Vice-President
  • UEMO, Portugal

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

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  Marcelien Callenbach, MSc

  • PhD student
  • Utrecht University, Netherlands

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  Dimitrios Athanasiou, MBA

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

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

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  Rosa Castro

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

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

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  Teresa Barcina Lacosta, PharmD

  • PhD researcher
  • KU Leuven, Belgium

  Teresa is a PharmD since 2018 and holds a bachelor's degree in biotechnology. Teresa is currently pursuing a PhD in pharmaceutical sciences at KU Leuven (Belgium). Her PhD project focusses on exploring market dynamics and sustainability of off-patent biologic and biosimilar medicines in Europe. This research is supported by the KU Leuven MABEL Fund, with the aim of investigating market environments for biologics following loss of exclusivity.