1. Course Aim: Benefit-risk assessment is now a fundamental science for understanding and evaluating the development, approval, and continued marketing of drugs and medical devices. This course is aimed at introducing attendees to core concepts and tools of both the science and practice of benefit-risk assessment.

2. Requisites Statement: This is a mid-level course designed to acquaint attendees with the current state of the art in the use of benefit-risk assessment methods and tools. Basic understanding of benefit-risk assessment concepts will be helpful for attendees to follow course content however there are no prerequisites for this course.

3. Course Objectives: Develop an understanding of current regulatory policies regarding the use of structured and quantitative benefit-risk assessment including roles for preference studies; Develop an understanding of methods for structured and quantitative benefit-risk assessment; Develop an understanding of how pharmacoepidemiology and benefit-risk assessment intersects with preference methods; Develop an understanding of how to successfully structure and present benefit-risk information for drug development decision-making and regulatory interactions, including the use of visual tools.