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Session 1 : Regulation and Future Perspectives
Session Chair(s)
Kazuhiko Mori, PhD, MSc
Senior Managing Director
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Speaker(s)
Looking Forward : A FDA Perspective for Master Protocols
Nicholas Richardson, DO, MPH
FDA, United States
Clinical Team Leader, Division of Hematologic Malignancies 2, OND, CDER
Master Protocol and Cohort Ready Trials for Neuroscience
Rami Suzuki, PhD
Ferring Pharmaceuticals Co., Ltd., Japan
Chief Executive Officer, Japan and Representative Director
Regulation and Present Profile of Clinical Trials for Approval of Pharmaceuticals in Japan
Daisuke Sato
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Coordinator, Office of Review Management
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