戻る Agenda
Session 1: Drug Development Strategy Utilizing East Asian Clinical Data: Industry Perspective
Session Chair(s)
Masahiro Takeuchi, DrSc, MPH
Professor,Dept. of Clinical Medicine (Biostatistics & Pharmaceutical Medicine)
Kitasato University School of Medicine, Japan
Akio Uemura, PhD
Senior Advisor
AU Consulting, Co., Japan
Utilization of East Asian Clinical Data in Asian Drug Development - Part 2: In the second part of the session, we would like to ask speakers from the pharmaceutical industry to discuss their strategies and future visions of new drug development in East Asia, e.g. using case studies of drugs that obtained approvals in Japan based upon Asian MRCTs.
Speaker(s)
Multiregional Clinical Trials (MRCTs) in Asia for Japanese NDA
Masaya Kato, PhD
Otsuka Pharmaceutical Co., Ltd., Japan
Manager, CMC Office, Medical Regulatory Affairs Department
Strategy on Planning of Multi regional Clinical Trials (MRCTs) in East Asia
Shigeru Nakaji, MSc
Astellas Pharma Inc., Japan
Vice President, RD Opearations, CRDO Office