Meet Confirmed Speakers from the National Authorities
We are honored to have over 100 non-industry speakers joining us at DIA Europe 2020, including 50 representatives from National Agencies of 19 countries, and 10 HTA delegates. The list below will be updated regularly, so we recommend browsing through it at least once per week. Take the time to get to know these and other key stakeholders and their backgrounds ahead of the conference!
Speakers from National Competent Authorities
Thomas Senderovitz, Director General, Danish Medicines Agency, Denmark
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the Clinical Pharmacological Department at Bispebjerg Hospital, Copenhagen. Thomas is Chair of HMA/EMA Joint Task Force on Big Data, member of the HMA Management Group and member of the EU Telematics Management Group.
Nikolai Brun, Chief Medical Officer & Director, Medical Evaluation and Biostatistics, Danish Medicines Agency, Denmark
MD from University of Copenhagen, with PhD studies at University of Pennsylvania. Dr. Brun practiced as a physician in the clinical field (Pediatrics) for a couple of years before continuing research and development work in the pharmaceutical industry especially working with biopharmaceuticals. Dr. Brun has authored a long list of publications in high-impact journals. Since 2017 he worked as Chief Medical Officer & Director of the Division for Medical Evaluation and Biostatistics in the Danish Medicines Agency. The Division covers both Human and Veterinary Medical Evaluation. He is also the Chair of the European Medicines Agency (EMA) /Heads of Medicines Agencies (HMA) Big Data Task Force as of April 2018.
Kristin Raudsepp, Director General, Estonian State Agency of Medicines, Estonia
Kristin Raudsepp is Estonian representative both in the EMA Management Board and at the EC Pharmaceutical Committee. She holds a position as the Director General at the Estonian State Agency of Medicines in Estonia.
Harald Enzmann, 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.
Elke Stahl, Assessor, Clinical Trial Unit, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany is a CoChair of the Clinical Trial Facilitation Group (CTFG) and involved in EMA’s EU CT information system groups as BfArM’s representative. She has been a pre-clinical assessor since 2005. Prior BfArM she has 10 years experience as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. She has a postDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC) and holds Ph.D. in pharmacology.
Lorraine Nolan, Chief Executive, Health Products Regulatory Authority (HPRA), Ireland
Dr. Lorraine 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 she was Director of Human Products Authorisation and Registration. Ms. Nolan is a member of the Management Board of the European Medicines Agency. Ms Nolan is a member of the Management Board of the European Medicines Agency and the EU HMA Management Group.
Yasuhiro Fujiwara, Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara has been Chief Executive, PMDA since April 2019. He is a medical oncologist, specializing in breast cancer. He was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital (NCCH). Before joining NCCH, he was a deputy director of the Evaluation Division II, PMDEC, from 1997 to 2002. PMDEC was a predecessor of PMDA. From 2011 to 2013, he was a Deputy Secretary General of Office of Medical Innovation, Cabinet Secretariat of Japan, and led health policy issues regarding life science.
Kazuhiko Mori, Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW), Japan
After graduating from Tokyo University in 1983, Mr. Kazuhiko Mori joined Ministry of Health & Welfare (later became MHLW) and served various important roles mostly in evaluation and safety information areas. ICH was one of his key contribution areas such as E5 and E8 guidelines, where he contributed to establish international guidelines originated from Japan (A figure showing the relationship between development phase and clinical trials are very well-known). He was very active in regulatory agency's international activities, and also in involving patients in drug development. Such effort is incomparable considering the impact to Japanese citizen and people all around the world.
Anja Schiel, Senior Advisor and Statistician, Norwegian Medicines Agency, Norway
Anja Schiel is working as Senior Advisor and Statistician for Norwegian Medicines Agency (NoMA). She has studied Biology at the Johannes Gutenberg-University Mainz, holds a PhD from the Free University Amsterdam and has many years of experience in medical research. Since 2017, she is also the Chair for the Biostatistics Working Party at EMA. Her role within NoMA involves working at the intersection of regulatory and HTA work, a unique perspective due to the structure of the Norwegian Agency.
Bruno Sepodes, Vice Chair, CHMP; Member of COMP, Portugal
Bruno Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon (Portugal). Besides being Senior non-clinical expert for INFARMED (Portuguese National Authority for Medicines and Health Products), he became a member of the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) in 2008, and served for two mandates as Chairperson of this Committee (2012-2018). Additionally, Bruno is also member of the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) and of the Committee of Advanced Therapies (CAT). In November 2018, Bruno was elected Vice-Chair of the Committee of Human Medicinal Products (CHMP).
Maria Lamas Diaz, Director, Spanish Agency of Medicines and Medical Devices, Spain
María Lamas Diaz is the Director of the Spanish Agency of Medicines and Medical Devices. PhD in Pharmacy from the University of Santiago, she is a specialist in hospital pharmacy and she is accredited as a clinical pharmacist in Oncology by the Board of Pharmaceutical Specialties (BPS) and the American Pharmaceutical Association (APhA). Before leading the AEMPS, she directed the Pharmacy Service of the Hospital of Santiago, while coordinating the Area of Platforms and Methodology of the Health Research Institute of Santiago (IDIS - ISCIII). In addition, she was the Research Director of the Spanish Society of Hospital Pharmacy from 2012 to 2016. She is currently coordinator of the Master of Pharmaceutical Oncology at the University of Valencia.
Oğuzhan Koyunc, Advisor to the President, Turkish Medicines and Medical Devices Agency (TITCK), Turkey
Oğuzhan Koyuncu is a pharmacist, graduate from Hacettepe University, Faculty of Pharmacy. In the same faculty, he completed his master of science in the area of Pharmaceutical Technology. He is still continuing Regulatory Science PhD. program in Yeditepe University. He has worked in various department in the Turkish Medicines Medical Devices Agency. Currently he is working as advisor to the president of the Agency with the title Health Specialist. He is married and has two boys.
June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
June Raine is a regulatory physician with experience in risk management and special interests in risk communication, access to medicines and information to patients: Chairman of the European Pharmacovigilance Working Party and member of the WHO Advisory Committee on Safety of Medicinal Products.
Jacqueline Corrigan-Curay, Director of the Office of Medical Policy, FDA, United States
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the development, coordination, and implementation of medical policy programs and strategic initiatives, including policy development on real world evidence, drug labeling, prescription drug promotion, clinical trial oversight and innovative trial design. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.
Theresa Mullin, Associate Director for Strategic Initiatives, OCD, CDER, FDA, United States
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads the Patient-Focused Drug Development initiative, which includes work related to the FDA Reauthorization Act and implementation of the 21st Century Cures Act. Leads FDA Patient Focused Drug Development and heads the FDA delegation to ICH. She previously served as director of CDER’s Office of Strategic Program (OSP) for almost a decade. Under her leadership, the office became a critical part of CDER’s sustained effort to modernize drug regulatory operations. Dr. Mullin received her bachelor’s degree in economics from Boston College and a Ph.D. in public policy analysis from Carnegie-Mellon University.
Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER
Director, Office of Surveillance and Epidemiology, CDER , FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the Council of International Organization of Medical Sciences and the International Council on Harmonisation. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. Before joining FDA, he was a faculty member in Neurology at Johns Hopkins.
Peter Mol, Principal Clinical Assessor, University Medical Center Groningen; Member SAWP, CBG-MEB, The Netherlands
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also an assistant professor 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.
Greet Musch, Director General, FAMHP, Belgium
Mrs Greet Musch has obtained a PhD in Pharmaceutical & Biomedical Sciences from the Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs. Afterwards, she joined the Federal Public Health services as senior quality assessor. Between 2004 and 2009 she was in charge of the R&D department. On February 2009 she has been designed as Director-general for the DG Pre-authorisation at the FAMHP.
Speakers from HTA
Regina Skavron, Scientific Adviser, Federal Joint Committee (G-BA), Germany
Regina Skavron graduated from the Medical School at the University of Cologne, Germany. She did a fellowship with the World Health Organization’s Regional Office for Europe in Copenhagen, Denmark and an M.Sc. in „Health Policy, Planning and Financing“ at the London School of Economics and the London School of Hygiene & Tropical Medicine. Skavron then joined Germany's Federal Joint Committee (GBA). She has since been a Scientific Adviser in the Pharmaceuticals Department. Her main responsibilities within the organisation's Pharmaceuticals Department lie in the early benefit assessments, the so called „AMNOG procedure“. She is involved in the decision making process following the assessments as well as the consultations of pharma companies.
Niklas Hedberg, Chief Pharmacist, Dental and Pharmaceuticals Benefits Agency (TLV), Sweden
Niklas Hedberg, MSc, is Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden. He is also Chair of the EUnetHTA Executive Board, TLV’s lead partner in EUnetHTA, and has led EUnetHTA WP3 – Evaluation since 2016. Mr. Hedberg has broad experience in different aspects of value-based evaluation, and has contributed to national pricing and reimbursement decisions for pharmaceutical products since 2001 and for medical devices since 2009. He previously served as Head of the Department for Pharmaceutical Submissions at TLV, after serving as investigator, medical assessor, and project leaders for the agency.
Pall Jonsson, Head of R&D, NICE, United Kingdom
Dr. Jonsson is the Head of Research and Development at UK's National Institute for Health and Care Excellence (NICE). He leads NICE's contribution to a portfolio of international research projects, in areas including big data and real-world evidence. Dr Jonsson has a PhD in biochemistry from University College London and worked in academia and the pharmaceutical industry before joining NICE. He sits on advisory boards of several international projects in the area of health technology assessment.
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