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