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SESSION 4 - What Should We Consider Building Risk-Based Quality Management System for Implementation?
Session Chair(s)
Toshiyuki Hata, PhD
Deputy Review Directior, Office of New Drug III
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Norio Shimazaki
Director, Regional Clinical Operations Japan, Korea and Taiwan
Bristol-Myers Squibb K.K., Japan
Speaker(s)
TransCelerate cQMS Update
Kiyomi Hirayama, PhD
Japan
Senior Director, Quality Management Unit Japan Development