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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 1: Update on Regulatory Environment in East Asia

Session Chair(s)

Yoshiko  Komuro, PhD

Yoshiko Komuro, PhD

Inspection Director, Office of Non-Clinical and Clinical Compliance

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Minsoo  Park

Minsoo Park

KCGI, Korea, Republic of

With the accelerated globalization of drug development in recent years, the importance of clinical development utilizing multi regional clinical trials (MRCT) especially in east Asian region is increasing mainly because of the higher similarity of ethnic factors within the region. Under such circumstances, Case of new drugs approved based on the results of MRCT in east Asian region are accumulating. In addition, since the postmarketing safety measures including the maintenance of labeling required by the regulatory agency varies in each region, Marketing Authorization Holders have to deal with each local regulations. In this session, experts from each regulatory agency will introduce the recent regulatory issues about drug development and safety measures in each region. Furthermore, topics regarding the new framework which some regulatory agencies have started to facilitate innovative drug development will be also introduced. It is expected to be helpful for drug development and fostering in east Asian region by understanding and utilizing the updated regulatory information.

Speaker(s)

Koshin  Kiyohara, MPharm, MSc

Update on Regulatory Environment in MHLW/PMDA

Koshin Kiyohara, MPharm, MSc

Ministry of Health, Labour and Welfare (MHLW), Japan

Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau

Myung-jung  Kim, MS

Update on Regulatory Environment in MFDS

Myung-jung Kim, MS

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

Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau

Hsueh-Yung (Mary)  Tai, MS

Update on Regulatory Environment in TFDA

Hsueh-Yung (Mary) Tai, MS

TFDA, Taiwan

Deputy Director, Division of Medicinal Products

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