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S3-1 - What’s new in ICH guidelines? (1)
Session Chair(s)
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Janis Bernat, MSC
Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Speaker(s)
Nihan Burul Bozkurt, PHD
Health Policies Director, Association of Research Based Pharmaceutical Companies (AIFD), Türkiye, Turkey
ICH E6 (R3) Guideline: Good Clinical Practice (GCP)
Osamu Komiyama
Senior Manager, Statistical Research & Data Science, Pfizer R&D Japan G.K., Japan
ICH E17 Guideline: General principles for planning and design of Multi-Regional Clinical Trials – Practical Implementation of MRCT
Xiaoni Liu, PHD
Executive Director, Head of Analytics China,GDD China Data & Digital, Novartis China, Hematology Biostatistics Team, China
ICH E20 Guideline: Adaptive Designs for Clinical Trials
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