Emerging Topics in Benefit-Risk Assessment
Weili He, Merck & Co. Inc.  *Qi Jiang, Amgen  John Scott, CBER FDA  

Keywords: Benefit-Risk, methods, uncertainties, graphics, data sources

Much emphasis has been placed on the structured benefit:risk assessment globally. The Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk Working Group (BRWG) has been actively pursuing several emerging topics in BR assessment. This presentation will cover the most current work from this working group, with emphasis on a few important emerging topics in BR assessment, including recommendation of the methods, identification and evaluation of uncertainties, graphics, and identification of different data sources.