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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)
ICH E6 (R3) Guideline: Good Clinical Practice (GCP)
Nihan Burul Bozkurt, PHD
Association of Research Based Pharmaceutical Companies (AIFD), Türkiye, Turkey
Health Policies Director
ICH E17 Guideline: General principles for planning and design of Multi-Regional Clinical Trials – Practical Implementation of MRCT
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
ICH E20 Guideline: Adaptive Designs for Clinical Trials
Xiaoni Liu, PHD
Novartis China, Hematology Biostatistics Team, China
Executive Director, Head of Analytics China,GDD China Data & Digital