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Nakano Sunplaza

Apr 15, 2013 7:00 AM - Apr 16, 2013 5:00 PM

4-1-1 Nakano, Nakano-ku, Tokyo, 164-8512 Japan

7th Annual Conference in Japan for Asian New Drug Development

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Workshop 1: Exploring Best Practices on Clinical Development related to Multi Regional Clinical Trials (MRCTs) in China, Korea, and Taiwan (2nd)

Session Chair(s)

Kosuke Mitsui, MBA, MSc, PMP

Kosuke Mitsui, MBA, MSc, PMP

President & General Manager

Chugai Pharma Science (Beijing) Co., Ltd., China

Kensuke Morimoto, MSc

Daiichi Sankyo Company, Limited, Japan

The DIA Annual Conference in Japan for Asian New Drug Development was established in Tokyo in May 2007. At that time, not many people in Japan were involved in Asian multinational clinical studies, Asian local clinical studies outside Japan, or Asian development regulatory aff airs. Now, several years later, there are more experienced individuals in Japan, and we have much more opportunities for collaboration with Asian countries. However, we need to ask ourselves an important question: Are our capabilities sufficiently advanced such that we can demonstrate adequate performance in the actual tasks required for Asian drug development individually? Answering this question was the leading motivation for holding the first tutorial session of DIA Japan at the DIA 6th Annual Conference in Japan for Asian New Drug Development, held in April 2012. The session chair and panelists shared their best practices on development regulatory affairs (at Tutorial Session 1) and clinical development (at Tutorial Session 2) related to multi regional clinical trials (MRCTs) in China, Korea, and Taiwan. Each session lasted for 90 minutes. Approximately half of the time during each session was allocated to answering questions from the audience, and it was very encouraging to see attendees forming long lines to ask questions.

Speaker(s)

Yuko Kikuchi, MS, RPh

Eisai Co., Ltd., Japan

Senior Director, Asia Regulatory Affairs

Min Kim

EPS International (Korea) Limited, Korea, Republic of

Country Director

Yumiko Kobayashi

Daiichi Sankyo Co., Ltd., Japan

Manager and Regulatory Leader, Regulatory Affairs Group, Asia Development Dept

Satoshi Kokubo, DVM, PhD

Astellas Pharma Inc., Japan

Senior Director, Medical Affairs

Isao Sasaki, PhD

Astellas Pharma Inc., Japan

Director, Asian Regulatory Affairs, Regulatory Affairs-Japan

Tetsuomi Takano, RPh

Tetsuomi Takano, RPh

Drug R&D Expert, Japan

Editor-in-Chief

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