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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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Senior International Health Sciences Advisor, Office of the Director, CBER, FDA
Dr. Limoli is currently with FDA's Center for Biologics' International Team serving as the Senior International Health Science Advisor.
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Interim Senior Executive Director, Therapeutic Products Directorate, Health Canada
Dr. Celia Lourenco is the Interim Senior Executive Director for the Therapeutic Products Directorate. She has been in management roles at Health Canada since 2007 and was until recently the director of the Bureau of Gastroenterology, Infection and Viral Diseases. She currently also...
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Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health 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 Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other...
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Vice President, Technical Regulatory Policy and International Operations, F. Hoffmann-La Roche
Wassim Nashabeh is the VP of Regulatory Policy & International Operations for Roche Pharmaceutical Group. Wassim is an assembly member of the International Council on Harmonization (ICH), the President of the CASSS Board of Directors, and a member of several advisory boards including...
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Operations Research Analyst, OCD, CDER, FDA
Amanda Roache is FDA's ICH Coordinator and has served as an Operations Research Analyst in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration since 2012. Ms. Roache works in CDER's International Program and facilitates scientific exchanges with...
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Deputy Vice President, Scientific and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Mr. Jerry Stewart, JD, MS, RPh, is Deputy Vice President at the Pharmaceutical Research and Manufacturers of America (PhRMA), located in Washington, DC, USA. He is responsible for international regulatory science policy and advocacy, and the global pharmaceutical manufacturing and...
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Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he...
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