返回 Agenda
Session Chair(s)
Osamu Komiyama
Senior Manager, Statistical Research & Data Science
Pfizer R&D Japan G.K., Japan
Speaker(s)
Overview for Benefit-Risk Assessment for Medications
Tomomi Kimura, MD, PHD
Janssen Pharmaceutical K.K., Japan
TF Lead, TF1, JPMA Data Science Subcommittee
Expectation for PBRER and its foresight – Insights from current situation both in EU and in Japan
Junko Sato, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
IMI-PROTECT Work Package 5 - Concept, results and the future of benefit-risk integration and representation in medicine
Deborah Ashby, PHD, MSC
Imperial College London, United Kingdom
Professor of Medical Statistics and Clinical Trials
BR balance assessment during life cycle of medicinal products (TBC)
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER