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[V3-S2] New Era of Benefit-Risk Balance Evaluation - Will Risk Information Keep Increasing? - (Part 2)
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)
Benefit-Risk Assessment - introduction to quantitative approach (MCDA) -
Akihiro Nakajima
Teijin Pharma Limited, Japan
Pharmaceutical Development Administration Department
Recent Progress in Benefit-Risk Evaluation Methodology and Practices: An Industry Perspective
Filip Mussen, PhD
Janssen R&D, Pharmaceutical Companies of Johnson & Johnson, Belgium
Vice President, Regional Regulatory Affairs
Xavier Luria, MD
(DDR) Drug Development and Regulation, Spain
Chair and Senior Consultant