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Council of Regulators

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

Chair

Leadership Committee

  
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.

Marwan Fathallah

  
Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.

Sabine Haubenreisser

  
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.

Michael D. Rosu-Myles

Vice Chair

  
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.

Peter Bachmann

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.

Alison Cave

  
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 PAULO 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.

Younjoo Park

  
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.

Joerg Schlaepfer

  
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.

Hiroshi Suzuki

  
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.

Patricia Oliveira Pereira Tagliari

  
Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree in International Affairs from the University of Brasilia (2004). She is currently a government employee, specialist in health regulation and surveillance, at the Brazilian Health Regulatory Agency - Anvisa. From April 2020 to the present date, Ms. Tagliari has served as Associate Director at Anvisa. Prior to that, she served as Advisor at Anvisa’s Office of Inspection and Health Surveillance and as the Head of Anvisa's International Affairs Office.

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