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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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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Global Head, Regulatory & Development Policy, Novartis Pharmaceuticals Corporation, United States
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation...
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General Manager of Medicines and Biological Products, ANVISA, Brazil
General Manager of Medicines and Biological Products at ANVISA, Brazil. Responsible for the management of drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brazil, and certification of bioequivalence centers. I have been...
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Deputy Director of CDE, Head of ICH China Office, National Medical Products Adminsitration (NMPA), China
Mr. Zhou is the deputy director of the Center for Drug Evaluation (CDE), NMPA, China. He has been entitled in 2017 council member for Chinese Pharmaceutical Association and executive member for China Pharmacopoeia Commission. Mr. Zhou has 12-years’ clinical review experience, as...
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