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Sola City Conference Center

May 22, 2014 10:00 AM - May 23, 2014 6:10 PM

4-6 Kandasurugadai, , Chiyoda-ku,, Tokyo, 101-0062 Japan

8th DIA Annual Conference in Japan for Asian New Drug Development

SESSION2-1: East-Asian Regulatory Update on Global Clinical Trials

Session Chair(s)

Yasuto  Otsubo

Yasuto Otsubo

Review Director, Office of New Drug II

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Minsoo  Park

Minsoo Park

KCGI, Korea, Republic of

Speaker(s)

Tao  Wang, MD, PhD

Tao Wang, MD, PhD

China Food and Drug Administration (CFDA), China

Director of Chemical Medicine Evaluation office II

Myung-jung  Kim, MS

Recent Status of Regulation and Clinical Trial in Korea

Myung-jung Kim, MS

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

Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau

Yasuto  Otsubo

Global Clinical Data Evaluation for Drug Approval in Japan

Yasuto Otsubo

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Review Director, Office of New Drug II

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