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.

Marieke De Bruin, PhD was trained as a pharmacist and epidemiologist. Her drug regulatory science research has focused on pharmacoepidemiology in the drug regulatory setting and pharmacovigilance. The main clinical areas are cardiovascular diseases and cancer. As of August 2016, she became professor in Regulatory Science at the University of Copenhagen and director of the Copenhagen Institute of Regulatory Science.

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.

Dr Helga Gardarsdottir is associate professor at the Division of Pharmacoepidemiology & Clinical Pharmacology (Utrecht University, NL). Her primary research interests include the application and development of innovative approaches to generate and analyse real world data on safety and effectiveness of medicines to inform regulatory and clinical decision making. Dr Gardarsdottir has led and participated in a number of international multi-country research projects including the IMI-PROTECT project and the IMI Trials@home project. Furthermore, she is a steering group member of ENCePP, the co-lead for the ISPE Real-World Evidence Task Force and an associate editor of the journal Pharmacoepidemiology and Drug Safety

Generalist with a broad understanding of policies across value chain in pharmaceutical and health sector. Stakeholder, alliance and project management expertise.

Anne holds a PhD in Biochemistry and Metabolic Engineering and an MSc degree in Molecular Biology, both from Copenhagen University. After 12 years of working with regulatory science in H. Lundbeck A/S, Anne established ANNE MORANT CONSULTING in June 2020, working as an independent regulatory science specialist on a freelance, part time basis. Anne specializes within analyses of clinical evidence supporting drug development as well as regulatory science-based advocacy activities including external collaborations, scientific publications, and conference presentations.

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

Doctoral degree in bio analytical chemistry from the VU University. In 2011 he joined Lygature, an independent not-for-profit organization that catalyzes the development of new medical solutions by driving public-private collaboration between academia, industry & society. Director of business development at Lygature & a guest lecturer on science & business topics related to public private partnerships. He coordinates several international public private partnerships, such as the European Lead Factory and the Non Biological Complex Drugs Working Group. He is a co-editor of the book on NBCDs in the AAPS Advances in the Pharmaceutical Sciences Series as well as co-author on a series of key-papers related to regulatory challenges for NBCDs.

i) Coordinates the Group of Pharmacological Sciences of the iMed.ULisboa, ii) for 20 years acted as expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK iii) has been (end July 2012) member of CHMP, CAT and SAWP and Chair of Safety Working Party and EU Co-Deputy in ICH M3R2, S6R1 and S1 guidelines. She consults on nonclinical drug development and is member of the NDA Advisory Board. She Chairs the Scientific Committee of the Innovative Medicines Initiative. Beatriz integrates the implementation Group of EUPATI (European Patient Academy) Portugal, and is a member of the Steering Committee and the Executive Committee of EUPATI National Platform.

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.

Susanne Bremer-Hoffmann, Dr. rer nat, holds a PhD in Biology from Charite Univ. Hospital Berlin for her work on the development of immunotherapies against leukemia. After post-doctoral research at the Federal Institute for Risk Assessment, she became a team member of ECVAM. Involved in formal validation studies of toxicological in vitro tests detecting embryotoxicity & endocrine disruption as well as their regulatory acceptance at the OECD. Collaborated in several FP6, FP7 projects - public/privat partnership initiative “SEURAT-1” focusing on the development of alternative methods for chronic toxicities. She represents the JRC in the "REFINE" project aiming to advance regulatory science in the field of nanomedicine and nano(bio)material.

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.

Sarra has worked more than 10 years in Genetics and in Gastroenterology with different positions at the University of Rome “Tor Vergata”. Also working for the Italian Medicine Agency (AIFA) since 2013 and obtained a permanent position in the Agency in 2018. Currently working as Preclinical and Clinical Assessor in the Pre-marketing department of the AIFA with various responsibilities as VHP coordinator, CTFG delegate and secretary. Bachelor’s degree in Molecular Biology, PhD in mucosal immunology, Master degree in Regulatory Affairs.

Petra holds an honorary senior researcher position at the Centre for Regulatory Science, Newcastle University. Her research focuses on access to essential medicines in low- and middle-income countries and the nature of clinical evidence underpinning expedited marketing authorisations by the European Medicines Agency.

Fatima is a fulltime student working on obtaining a double degree in Pharmacy and Health Economics, Policy & Law. Her main interests lie within the regulatory sciences and pharmaco-economy. As part of the pharmacy master, she followed an internship at the Dutch Medicines Evaluation Board focusing on post-marketing efficacy trials.

Florence van Hunsel (1981) studied Pharmaceutical Sciences at the University of Utrecht in the Netherlands from 1999-2005. She has been working at the Netherlands Pharmacovigilance Centre Lareb since 2005 where she is currently Head of Signal Detection. Florence wrote her PhD thesis on ‘The contribution of direct patient reporting to pharmacovigilance’ (University of Groningen, 2011). She is still actively involved in studies on patient reporting in pharmacovigilance and has supervised multiple PhD projects on this topic.

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.

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.

During his work as programme manager and consultant he was involved in several projects on various regulatory science topics around biologics, complex medicines, pharmacovigilance and new regulatory approaches to accelerate patients’ access to medicines. Kevin has a background in Bio-Pharmaceutical Sciences at Leiden University and a specialisation in Science Based Business. As of 2015 he combined his work as a consultant and programme manager with a PhD at the WHO Collaborating Centre for Pharmaceutical Policy and Regulation located at the Division of Pharmacoepidemiology and Clinical Pharmacology of Utrecht University. In 2019, Kevin successfully defended his PhD thesis titled ‘Regulation in the dynamic environment of complex medicines’.

Maren is currently serving as Director of Regulatory and Scientific Policy at Merck Healthcare KGaA, Darmstadt, Germany. She has close to 20 years of experience within the pharmaceutical industry (Merck, Takeda, Nycomed, Altana, Hill&Knowlton), of those >5 years in medical communications and public relations and 14 years in global regularly affairs. She held responsibilities as global regulatory lead in different indications, in global CMC lead and in policy. Maren is a chemist by training and received a PhD in cardiovascular molecular biology from Imperial College in London, as well as a Masters in Drug Regulatory Affairs from Bonn University.

Lotte Minnema is a PhD candidate at the division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS). The research is focused on pharmacovigilance of biopharmaceuticals. Next to this PhD track, Lotte works as a pharmacovigilance assessor at the Dutch Medicines Evaluation Board (CBG-MEB).

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

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.

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.

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

Elisabeth Bakker, MSc graduated from the master Medical Pharmaceutical Science at the University of Groningen in September 2019 and is currently working as a PhD candidate at the department of Clinical Pharmacy and Pharmacology of the University Medical Center Groningen. During her studies, an internship at the Dutch Medicines Evaluation Board triggered her interest towards the regulatory field. Her current research is mainly focused on the alignment of precision medicine drug development trajectories with regulatory decision-making needs

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

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.

Pauline joined the National Health Care Institute in 2009. Since 2013 she is a secretary of the Scientific Advisory Committee responsible for the pharmaco-therapeutic and pharmaco-economic assessment reports discussed in the committee. In 2019 she started a pilot together with the Dutch Medicines Evaluation Board (MEB) named ‘MEB-ZIN Parallel Procedures pilot’. Within this pilot, the organisations are exploring a more parallel procedure for authorisation and reimbursement assessments, instead of the current sequential processes. Before 2009 she worked at the pharmaceutical company MSD at the clinical research department.

Katrine Schultz-Knudsen is currently working as professional in Regulatory Science & Strategy at Lundbeck headquarters in Copenhagen, focusing on regulatory science analysis activities and supporting Lundbeck's regulatory strategy with these. Katrine graduated from the University of Copenhagen in August 2019 with a masters in molecular cell biology. During her studies, she worked for Lundbeck's R&D outsourcing department.

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is a service provider and associate department of the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.

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.

João Duarte is currently Director, Business Planning & Operations at Alexion, AstraZenenca Rare Disease. João serves as Chief of Staff to the Head of Regulatory & Quality Affairs and leads regulatory policy activities within the team. He held several roles since 2012 in Regulatory Intelligence & Policy, notably at Lundbeck and Takeda, where he worked to help colleagues to better understand the shifting regulatory environment and to support drug development in several therapeutic areas globally. João also worked briefly in the generics industry in Portugal and at the European Medicines Agency as a trainee.

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

Wim Goettsch, PhD is currently Special Advisor HTA at the Dutch National Health Care Institute He was the Director of the EUnetHTA JA3 (2016-2020) Directorate and Chair of the Executive Board of EUnetHTA between June 2016 and March 2018. Since 2019, he also has a position as an Associate Professor at Utrecht University (NL) where he is leading a new H2020 consortium with fifteen partners around Europe, called HTx, new methods for Health Technology Assessment (2019-2024). He is currently Director in the Board of HTAi (2019-2022) and member of the Editorial Board of the International Journal of Technology Assessment in Health Care (IJTAHC). He has more than 80 publications in peer-reviewed international journals.

Current role is Regulatory Affairs Head US, Early development and Business Development and Licensing in Novartis Pharmaceuticals Corporation. Prior experience includes global and European regulatory affairs roles in Novartis and GSK in areas including Metabolism, Cardiovascular, Oncology & Vaccines.

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.

Michael D. Nguyen, MD is the FDA Sentinel Program Lead and Deputy Director of the Regulatory Science Staff in the Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER). He oversees the day-to-day management of the Sentinel Program for the Agency and coordinates scientific operations, routine safety analyses, and data infrastructure development.

Mihai Rotaru is Project Manager Market Access in the Economic and Social Affairs team of EFPIA. Among his responsibilities, Mihai coordinates the work regarding all supply chain related issues including the implementation of the Falsified Medicines Directive. Previously, he has worked as Corporate Affairs Manager within GIRP (representing full-line wholesalers in Europe), where he has worked on supply chain issues and has acquired solid experience in addressing EU healthcare sector’s challenges.

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.