This course presents an overview of risk management principles, with a focus on best practice methods for designing, implementing and evaluating risk minimization programs. For the 2020 ICPE, this course will consist of a 90 minute, pre-recorded moderated session, and a follow-up, 60 minute live session. The pre-recorded session will include a didactic component which will feature presentations from experts in regulatory, industry, academia and research organizations who will present three modules on scientific frameworks, methodologies and an illustrative case application. The session will include moderated panel discussion about pragmatic considerations for effective risk minimization program design, implementation and evaluation techniques. The live session will provide an opportunity for participants to ask clarifying questions of the course faculty and to share perspectives on pragmatic applications given the regulated context of risk minimization programs.
