The Council of Regulators contributes essential, nuanced, and collective insights on the common interests of regulatory bodies from around the world.
Japan Pharmaceuticals and Medical Devices Agency
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference on Harmonisation Technical Coordinator; as ICH E15 and E16 topic leader; as Division Director, Regulatory Science Research; as Division Director, Review Planning and Pharmaceutical Affairs Consultation; as Director, Division of Epidemiology; and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group. Dr. Uyama earned his PhD from Nagoya City University and his post-doctoral research focused on promoting science within Japan.
Federal Institute for Drugs and Medical Devices (BfArM)
Peter Bachmann 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 joint in 1999 the BfArM, Department of ‚Drug Approval‘.
Currently he 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, the European Lead of the ICH IGDG (Informal Generic Discussion Group)
European Medicines Agency
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.
World Health Organization
Emer Cooke was appointed as Head of Regulation of Medicines and other Health Technologies with the World Health Organization (WHO) in Geneva in Nov. 2016. In this role, Ms. Cooke is responsible for leading WHO's global work on regulation of health technologies (medicines, vaccines, diagnostics, vector control products and devices), coordinating the regulatory teams (Norms and Standards, Prequalification, Regulatory Systems Strengthening), and working with member states and international partners to assure the quality, safety and efficacy of appropriate health technologies. Ms. Cooke obtained her degree in pharmacy from Trinity College in Dublin, Ireland. She has additional Masters degrees in Science and Business Admin., also from Trinity.
Gerald J. Dal Pan
Food and Drug Administration
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.
Yee Hoo Looi
Health Sciences Authority
Yee Hoo Looi, PhD, is Deputy Director of Therapeutic Products Branch of the Health Products Regulation Group, Health Sciences Authority (HSA), which administers the regulation and pre-market evaluation for drug registration in Singapore. Dr. Looi started his HSA career as an evaluator for both clinical and toxicology review, and currently leads non-clinical evaluation and helps to oversee benefit-risk assessment for marketing approval. Prior to joining HSA, he conducted safety assessments of drug candidates as an industry pharmacologist. Dr. Looi earned his PhD in Pharmacology from the University of Strathclyde (United Kingdom), and completed his post-doctoral training, focusing on heart failure research, at King’s College London.
Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia represents Health Canada at the Assembly and Management Committee of the International Council for Harmonization and at the Management Committee of the International Pharmaceutical Regulators Programme.
Dr. Jörg Schläpfer, PhD is the Head of Communication and Networking and Member of the Management Board of Swissmedic. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine, completing his PhD and undertaking 12 years of academic research, he was employed by a number of companies in various roles within the pharmaceutical industry from 2002 to 2015. Since the end of 2015, Jörg Schläpfer has been Head of Division Process Development and Support in the Authorisation sector at Swissmedic as well as Deputy Head of the sector.
Kyung Won Seo
Ministry of Food and Drug Safety
Dr. Kyung Won Seo serves as Director General of the Drug Evaluation Department at the Ministry of Food and Drug Safety, Republic of Korea since February 2019. Dr. Seo oversaw several divisions as Director including metabolic, reproductive and respiratory product; antibiotics and oncology product; and bioequivalence evaluation. Prior to her current position, she served as Director General of Pharmaceutical and Medical Device Research Department from 2015 to 2019. Dr. Seo obtained her Ph.D in toxicology from Kyunghee University in 1996 and her MBA degree from Dongguk University in 2015. Dr. Seo received awards including the President’s Commendation in 2012 and the Service Merit Medal from Ministry of Public Administration of Security in 2019.