6th DIA Clinical Operations and Monitoring Workshop in Japan

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SESSION 4 - What Should We Consider Building Risk-Based Quality Management System for Implementation?

Deputy Review Directior, Office of New Drug III

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Director, Regional Clinical Operations Japan, Korea and Taiwan

Bristol-Myers Squibb K.K., Japan

Kiyomi Hirayama, PhD

Japan

Senior Director, Quality Management Unit Japan Development

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