Back to Agendas
[V3-S1] New Era of Benefit-Risk Balance Evaluation - Will Risk Information Keep Increasing? - (Part 1)
Session Chair(s)
Osamu Komiyama
CEO, Office Komiyama, 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)
Stephen P. Spielberg, MD, PhD
Editor-in-Chief, DIA, United States
Personalized Medicine and Benefit-Risk: Impact on REMS and Other Approaches to Safety
Xavier Luria, MD
Chair and Senior Consultant, (DDR) Drug Development and Regulation, Spain
Current Trends in Benefit/Risk Assessment of Medicines and Regulatory Impact from the EU Perspective
Shinobu Uzu, PhD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
New era of Benefit Risk Balance evaluation – Risk information keep increasing?
Have an account?