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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

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

13th DIA Japan Annual Meeting 2016

[V1-S2] Future of Clinical Development Strategy in Asia after ICH E17 Guideline Implementation

Session Chair(s)

Yoshiaki  Uyama, PhD, RPh

Yoshiaki Uyama, PhD, RPh

Associate Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

The ICH-E17 guideline “General principle on planning/designing Multi- Regional Clinical Trials” is currently under consideration. Regulators from Asia will present the harmonized guideline, focusing on implementation in their own countries, changes in the drug development strategy, and assumed challenges in guideline implementation.

Speaker(s)

Lih-Jiuan  Hsu

Future of Clinical Development Strategy in Taiwan after ICH E17 Guideline Implementation - the Perspective of a Regulator

Lih-Jiuan Hsu

Center for Drug Evaluation, Taiwan, Taiwan

Deputy Executive Director

Katsuhiko  Ichimaru

Review Experiences of Multi Regional Clinical Trials (MRCTs)(Asian Trials)

Katsuhiko Ichimaru

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Review Director, Office of New Drug IV

Koichi  Miyazaki, PhD

How ICH E17 Affects Clinical Trials in Asia

Koichi Miyazaki, PhD

Daiichi Sankyo Co., Ltd., Japan

Senior Director, Group IV, Oncology Clinical Development Department

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