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Tokyo Big Sight

Nov 15, 2015 9:30 AM - Nov 17, 2015 5:45 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

12th Annual Meeting DIA Japan 2015

The registrants will have access to presentation PDFs through Tuesday, May 17, 2016.

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[V6-S3] Tips for Better Drug Development Strategy in Asia - Let's Give Honest Opinions

Session Chair(s)

Kensuke Morimoto, MSc

, Daiichi Sankyo Company, Limited, Japan

Recently, the number of multi-national clinical studies in Japan has increased, and Asian study has become popular as a drug development strategy owing to relatively small ethnic difference in this population. By conducting Asian studies sponsors may shorten development time and save cost, and the study results are not only leveraged for NDA in Japan but for other Asian countries and regions. However, certain diversity is observed in this region in regulation, health care environment and culture. Therefore when conducting Asian Studies Sponsors need to take a flexible approach based on the previous experience in international arena. In this session, we have invited speakers from Japan, China, and Taiwan who are familiar with Asian studies, to experience and share ideas. After their presentations we will open a panel discussion to discuss how Asian studies should be conducted and managed. We hope this session contributes to your drug development strategy in Asia.

Speaker(s)

Suggestions to Promote Asian Studies - From a Japanese Perspective

Akiko Nakahama

Exective Director,Clinical Development Japan, Eisai Co., Ltd., Japan

Drug Development in China

Li HANG

Manager, Daiichi Sankyo (China) Holdings Co., Ltd., China

Suggestions to Promote Asian Studies - From a Taiwanese Perspective

Sarah Shan-Erh Lin, MSc, RPh, PMP

Senior QA Manager, Emerald Clinical, Taiwan

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