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Session Chair(s)
Satoshi Matsushita
Director, R&D QA Department
Janssen Pharmaceutical KK, Japan
Speaker(s)
Impact of ICH E6 Revision on Quality Management Activities in Clinical Trials - From PMDA Point of View
Naoyuki Yasuda, MSc
Pharmaceuticals and Medical Devices Agency, Japan
TransCelerate Clinical Quality Management System Initiative Update
Ann Meeker-O'Connell, MS
Novartis, United States
Executive Director, Monitoring Excellence Head
Merck/MSD Clinical Quality Management Model
Kiyomi Hirayama, PhD
MSD K.K., Japan
Senior Director, Quality Management Unit Japan Development
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