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, PhD, chairs the Coordination Group for Mutual Recognition and Decentralised Procedures – human, and is a Member of the Scientific Coordination Board of the European Medicines Agency. He is also Head of the Unit of European Coordination and Deputy-Head of the Division of European and International Affairs for the German Federal Institute for Drugs and Medical Devices. Dr. Bachmann is Drug Regulatory Affairs lecturer at the Universities of Bonn, Duisburg-Essen, Basel, and Copenhagen; an honorary member of the Middle-European Society for Regulatory Affairs; and an honorary lifetime member of The Organisation for Professionals in Regulatory Affairs. He earned his Doctorate of Natural Sciences from the University of Wuerzburg.
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.
Petra Dörr, PhD, serves as Head of Communication & Networking, and as Deputy Executive Director, of the Swiss Agency for Therapeutic Products (Swissmedic), where she is responsible for external communication as well as national and international cooperation. Dr. Dörr is a member of the Management Committee of ICH and IPRP. Since November 2018, she serves as the vice-chair of the ICH Assembly. She has been the chair of the International Pharmaceutical Regulators Forum from 2013 to 2016 and a member of the Advisory Council of the Centre for Innovation in Regulatory Science until the end of 2018. She joined Swissmedic after 10 years in industry as Head of International Affairs in 2004 and has been a member of the Management Board since 2007.
Jeong Mi Kim
Ministry of Food and Drug Safety
Jeong Mi Kim, MD serves as Director of the Clinical Trials Management Division (CTMD) in the Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety (MFDS). The CTMD is responsible for ensuring the validity of clinical trial data submitted to MFDS in support of applications to demonstrate the safety and efficacy of drugs for human use. 2013-2016, she was responsible for implementing drug safety strategies based on Korean pharmacogenomics information and preparing a foundation for management of safety and effectiveness of off-label use of drugs as a Director of the Clinical Research Division in National Institute of Food and Drug Safety Evaluation (NIFDS). Dr. Kim received her medical degree from School of Medicine, Hallym University.
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 Biologics and Genetic Therapies Directorate (BGTD) 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.
World Health Organization
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously worked within Health Canada as GMP specialist, drug evaluator and manager, international policy analyst, and Manager of the International Programs Division of the Therapeutic Products Directorate. Mr Ward served on many international harmonization steering committees and helped to launch the APEC Regulatory Harmonization Steering Committee, the International Generic Drug Regulators Pilot, and the International Medical Device Regulators Forum.