The Council of Regulators contributes essential, nuanced, and collective insights on the common interests of regulatory bodies from around the world.
Gerald J. Dal Pan
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.
Michael D. Rosu-Myles
Dr. Rosu-Myles is the acting Director General of the Biologic and Radiopharmaceutical Drugs Directorate, Adjunct Prof. at the Univ. of Ottawa and the Health Canada lead for the WHO Collaborating Centre for the Standardization and Evaluation of Biologicals. His team leads on the regulation of all biologics and radiopharmaceuticals in Canada. After taking on the role of ED for the team responsible for vaccine regulation in 2018. He has played a leadership role in the implementation of Health Canada’s response to the COVID-19 pandemic and in the development of implementation of their new Advanced Therapy Regulations. He received his Ph.D. in Immunology and Microbiology from the Univ. of Western Ontario.
Fellow of DIA
Peter Bachmann 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, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He 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 joined in 1999 the BfArM, Department of Drug Approval.
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.
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.
Rogerio S. Gaspar
Dr. Rogério Gaspar from Portugal joined WHO January 6, 2021, as the Director of Regulation and Prequalification Department. He obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after a graduation as pharmacist from the University of Coimbra Portugal. He was a Full Professor at the Faculty of Pharmacy University of Lisbon until the end 2020, where he was Head of Department and President of the School Council. He was a member of the management board of EMA and VP of the management board at Portugal’s NRA (INFARMED). He also participated in activities against medicines counterfeiting and from 2000-2002 lead the participation of Portugal within International Narcotics Control Board (INCB).
Yee Hoo Looi
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.
Dr. Younjoo Park serves as Director General of the Drug Evaluation Department at the Ministry of Food and Drug Safety, Republic of Korea since March 2021. Dr. Park is responsible for overall drug review and approval, pharmaceutical standardization, and generic drug review. For 20 years after joining MFDS, Dr. Park took charge of several divisions as Director including oncology and antimicrobial products, recombinant protein products, and cell and gene therapy products etc. Before the current position, Dr. Park served as Director General of Pharmaceutical and Medical Device Research Department in 2019-2021. Dr. Park obtained her Ph.D. in pharmcology from Seoul National University in 2001.
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.
Dr. Hiroshi Suzuki is the Director of Center for Regulatory Science, PMDA, since April 2020. He is also serving as the Professor & Chair and Director of Department of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo, since June 2004, and is responsible for the management of the activities of approximately 90 hospital pharmacists, research and education. His major field is the molecular pharmacology (analysis of metabolic and locomotive syndromes) and clinical pharmacology (PK/PD, pharmacometrics, and systems-biology) which are closely related to the regulatory sciences.