Hammad T, Hauber AB, Juhaeri J, Noel R. Weighing the benefits & risks: the science and methods of benefit-risk assessment in drug development. Presented at the 34th Annual ICPE Conference; August 23, 2018. Prague, Czech Republic.


Benefit-risk assessment is now a fundamental science for understanding and evaluating the development, approval, and continued marketing of drugs and devices. This course is aimed at introducing attendees to core concepts and tools of both the science and practice of benefit-risk assessment. Educational Objectives: • Develop an understanding of quantitative benefit-risk assessment methods and software tools • 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 patient engagement, by developing an understanding of the use of preference methods

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