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Quality of Japanese Clinical Trials and Proposed Strategy for the Trial Sites

Time

Wed, Jun 18 7:15AM
W 29

Title

Quality of Japanese Clinical Trials and Proposed Strategy for the Trial Sites

Abstract Summary

Existing reports on (a) the characters of Japanese clinical trials, (b) the current Japan’s policies on clinical development, and (c) the current risk-based approach to the quality of clinical trials were studied. The author formulated a strategy for Japanese trial sites based on the findings.

Poster Presenter

Toshiyoshi Tominaga
Associate Executive Director for International Programs,
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan