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Activity Number: 237
Type: Topic Contributed
Date/Time: Monday, August 1, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #319965
Title: Safety-Monitoring Methodology in the Premarketing Setting
Author(s): Melvin Munsaka*
Companies: Takeda Development Center
Keywords: Safety Monitoring ; Bayesian ; Frequentist ; Premarketing ; Post Marketing

To better promote public health and protect patient safety, there is growing interest for systematic approaches for safety evaluation of drug products. This applies to both post-marketing and pre-marketing settings. Recent regulatory guidance highlights the importance and provides recommendations on aggregate safety monitoring. Safety monitoring, spans from individual trial level to program level, from unblinded to blinded, from expected to unexpected AEs and from patient profiles to aggregate safety tables and figures, supporting DMC and benefit-risk assessments and serves to lay a foundation for IAS preparation and benefit-risk assessment. To better enable this, the ASA Biopharm Section in 2015 established a Safety Working Group. One focus areas of the working group is safety monitoring. This presentation will discuss part of the work of this working group. The discussion will focus on the methodological approaches for safety monitoring in the pharmaceutical development life cycle, including, blinded vs unblinded, frequentist vs Bayesian, and premarketing vs post marketing methods, static vs dynamic looks, visualization, and trial-level vs program-level safety data aggregation.

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

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