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[V2-S4] What is the Benefit-risk Balance Assessment which Japan is Aiming for? - Strategy for Generation of Useful Information which Contributes to Patients
Session Chair(s)
Rei Maeda
Consultant
Independent Consultant for Drug PV, Japan
Speaker(s)
Positioning Benefit-risk Balance Assessment in Japan - From Company's Point of View
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Current Situation of Benefit-risk Balance Assessment in EMA
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
Possibility of Medical Big Data
Patrick Frey
Amgen, United States
Director, Global Regulatory and R&D Policy
The Future Direction of Japan Regarding Benefit-risk Balance Assessment
Akiko Hori, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Regulatory Science
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