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TOC Ariake Convention Hall

Apr 13, 2016 9:00 AM - Apr 14, 2016 6:00 PM

3-5-7 Ariake, , Koto-ku, Tokyo, 135-0063 Japan

10th DIA Asia New Drug Conference in Japan

The registrants will have access to presentation PDFs through Thursday, October 13, 2016.

Session 2: Drug Development Using Asia Multi-Regional Clinical Trials (Part 1)

Session Chair(s)

Koichi  Miyazaki, PhD

Koichi Miyazaki, PhD

Senior Director, Group IV, Oncology Clinical Development Department

Daiichi Sankyo Co., Ltd., Japan

Yoshiaki  Uyama, PhD, RPh

Yoshiaki Uyama, PhD, RPh

Associate Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Our goal is to bring innovative new drugs to patients as soon as possible through thoughtful and efficient drug development. To achieve the purpose, multi-regional clinical trials (MRCT) is now widely recognized as an optimal and efficient drug development pathway by avoiding duplicative works. In fact, regulatory authorities have undertaken many important initiatives and released guidelines/notices to promote their countries to participate in MRCT and to use the clinical data from MRCT for regulatory application. Among them, Asia MRCT is especially expected to be a pivotal strategy for the regulatory application in the region because of ethnic similarity. On the other hands, some challenges in evaluating data from MRCTs still remain. In this session, speakers from health authorities and pharmaceutical companies will address current status and future prospects of MRCT to help you to explore these increasingly important issues.

Speaker(s)

Gau  Churn-Shiouh, DrSc

Regulatory Trends of MRCT (TCDE)

Gau Churn-Shiouh, DrSc

Project Office of Sustainable Platform For Big Data In Health by MOHW, Ching-Kan, Taiwan

Office Director

Sun-young  Kim, MS

Regulatory Trends of MRCT (MFDS)

Sun-young Kim, MS

Ministry of Food and Drug Safety (MFDS), Korea, Republic of

Assistant Director, Clinical Trials Management Div, Pharmaceutical Safety Bureau

Akihiro  Ishiguro, PhD

Regulatory Trends of MRCT (PMDA)

Akihiro Ishiguro, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Review Director, Office of New Drug III

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