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Activity Number: 597
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #319572 View Presentation
Title: Benefit-Risk Assessment via Case Studies
Author(s): George Quartey* and Qi Jiang and Weili He
Companies: Genentech and Amgen and Merck
Keywords: Benefit-risk Assessment ; Benefit-risk framework
Abstract:

The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe five real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations for a full benefit-risk evaluation.


Authors who are presenting talks have a * after their name.

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