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SESSION 2:UPDATE ON ICH GUIDELINES Track 1 E17 – Impact on Development Strategy
Session Chair(s)
Yoshiaki Uyama, PhD, RPh
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Overview of ICH E17
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Regulator’s Expectations for E17 GL- From PMDA’s Perspectives
Yoko Aoi, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug V
US FDA Perspective on ICH E17
Lisa LaVange, PhD
University of North Carolina at Chapel Hill, United States
Professor Emerita
Regulator’s Expectations for E17 GL- From EMA’s Perspectives
Armin Koch, DrSc
Hannover Medical School, Germany
Head, Institute of Biometry
What Can Be Done in the PlanningStage of MRCT?A Statistical Perspective
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Industry’s Expectations for E17 GL- From PhRMA’s Perspectives
Laurie Letvak, MD
Novartis Pharmaceuticals Corporation, United States
Head Clinical Policy and Medical Ethics
ICH E17 Regulatory considerations and challenges from a sponsor point of view
Vibeke Bjerregaard, MS
Novo Nordisk A/S, Denmark
Senior Regulatory Policy Manager
William Wang, PhD
Merck & Co, Inc, United States
President
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