Quantitative assessments of benefits and harms of medical products can inform drug and device developers, regulators, health technology assessors, and other health professionals to make better health-related decisions. Quantitative benefit-risk assessment differs from qualitative assessments by incorporating explicit outcome weighting into the analysis. This course will introduce multi-criteria decision analysis (MCDA) based methods for quantitative benefit-risk assessment with real-life examples. We will describe the history and go through emerging good research practices of benefit-risk assessment, including how patient preference data can be incorporated. The course will explain step by step how to develop quantitative benefit-risk model with a case study. This course is based on the principles of the ISPOR Benefit Risk Assessment Emerging Good Practices Task Force Report.