Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related international regulatory policy, advocacy in...
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Consultant, Compliance, Quality and Scientific Affairs, Dr. Reddy's Laboratories
Dr. Cappuccino is currently a Consultant for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH...
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Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
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...
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Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs...
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ICH Assembly Chair and Senior Expert, European Commission, European Commission
Lenita Lindström-Gommers is a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is responsible for international relations in the field of pharmaceuticals. Her main work relates to ICH where she was closely involved...
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Senior Vice President Global Regulatory Affairs and Group Head Development China, Pfizer Inc, United States
Peter Honig, M.D., M.P.H, is the Senior Vice President and Head of Worldwide Safety and Regulatory at Pfizer with expertise in clinical pharmacology, clinical program and clinical trial design, compliance, medical product safety, and medical product regulation. He is a past President...
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Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee...
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