Back to Agendas
[V3-S1] New Era of Benefit-Risk Balance Evaluation - Will Risk Information Keep Increasing? - (Part 1)
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
In general, safety information increases depending upon drug exposure. Within few years after launch, reporting rates incrementally decrease until reporting is flat. In this session, experts from three regions will present the difference between ADRs and risk, and the difference between efficacy and benefit, which situations mean that “benefits outweigh risks” and how to express it, who assesses the benefit-risk balance, and how to utilize it. Organization, specification of responsible persons, and current and future issues regarding tis benefit-risk balance assessment will be addressed in a panel discussion representing these three regions.
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
Have an account?