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Activity Number: 324
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #315467 View Presentation
Title: What Is the Role of Statisticians in Benefit-Risk Adoption Within Our Companies?
Author(s): Susan P. Duke* and Greg Anglin
Companies: GlaxoSmithKline and Eli Lilly Corporation
Keywords: benefit-risk ; safety ; QSPI ; pharmacovigilance
Abstract:

This talk is based on the efforts of the QSPI Benefit Risk Working Group Best Practice subteam. It will elaborate on the vital contribution of statisticians to the adoption and use of benefit-risk practice within sponsor companies. It will touch on how Benefit-Risk structured thinking and quantification are affecting the drug development/pharmacovigilance process, with a specific focus on the essential role played by statisticians, demonstrating how decision-making is improved by use of structured benefit-risk thinking and quantification.


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

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