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Session Chair(s)
Osamu Komiyama
Senior Manager, Statistical Research & Data Science
Pfizer R&D Japan G.K., Japan
Rei Maeda
Consultant
Independent Consultant for Drug PV, Japan
Speaker(s)
Personalized Medicine and Benefit-Risk: Impact on REMS and Other Approaches to Safety
Stephen P. Spielberg, MD, PhD
DIA, United States
Editor-in-Chief
Current Trends in Benefit/Risk Assessment of Medicines and Regulatory Impact from the EU Perspective
Xavier Luria, MD
(DDR) Drug Development and Regulation, Spain
Chair and Senior Consultant
New era of Benefit Risk Balance evaluation – Risk information keep increasing?
Shinobu Uzu, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director
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