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Session 5 / Venue 2: Adaptive Licensing ~ (English Language only)
Session Chair(s)
Yasuhiro Fujiwara, MD, PhD
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
In recent innovative drug development, one of the challenges is what level of efficacy and safety should be confirmed at the time of regulatory approval even though a certain level of uncertainty remains. This session will deliver speeches about new concept “adaptive licensing” from regulator, academia, and industry. The panel discussion will explore how approval process should be in future.
Speaker(s)
Concept and Implementation of Adaptive Licensing in EU (Remote presentation via internet)
Tomas Salmonson, DrMed, PhD
Critical Path Institute, United States
Partner
Academic Expectation on the Future Drug Approval System
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive
Industry Perspective on the System of Future Drug Approval
Satoshi Kawaoto
Novartis Pharma K.K., Japan
Corporate Officer, Head of Drug Regulatory Affairs Dept.
Regulatory Perspective on Future Direction of Drug Approval System in Japan
Daisaku Sato, PhD, MPharm, RPh
Ministry of Health, Labour and Welfare, Japan
Director, Compliance & Narcotics Division
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