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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
Neurocrine Biosciences, United States
Senior Director, Regulatory 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