7th Annual Conference in Japan for Asian New Drug Development

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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

Executive Director, Development Division

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