The Council of Regulators contributes essential, nuanced, and collective insights on the common interests of regulatory bodies from around the world.
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.
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.
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.
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, 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.
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, 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.
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.