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Conducting Clinical Trials in Japan

Date: 14 Oct. 2013  |  Topic: Pharmaceutical
Yasmine Chiu M.D.

Yasmine Chiu, M.D.

Senior Medical Director, Pharmacovigilance
PPD

Japan has become a more attractive market for foreign and domestic pharmaceutical companies and the contract research organizations (CRO) that support them. Challenges remain, however, and this paper summarizes current PMDA processes, compares Japanese and international standards for Good Clinical Practice (GCP), examines cultural factors that may affect clinical trials and discusses the role of CROs in the management of clinical trials in Japan.

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