Gilsenan A, Juhaeri J, Poulos C, Levitan B. Weighting the benefits & risks: the science and methods of benefit-risk assessment in drug development. Presented at the 2022 ICPE Conference; August 25, 2022. Copenhagen, Denmark.

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. Requisites Statement This is an introductory to mid-level course designed to acquaint attendees with the current state of the art in the use of benefit-risk assessment methods and tools. There are no prerequisites for this course.

--Develop an understanding of current regulatory policies regarding the use of structured and quantitative benefit-risk assessment including role for preference studies
--Develop an understanding of methods for structured and quantitative benefit-risk assessment
--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
--Develop an understanding of how pharmacoepidemiology and benefit-risk assessment intersects with preference methods

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