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Activity Number: 108 - New Era for Safety Evaluation
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #327063 Presentation
Title: Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights
Author(s): Olga Marchenko*
Companies: Bayer
Keywords: Adverse events; Safety assessment; Real World Data

In this presentation, different sources of safety data will be briefly reviewed and selected statistical strategies and methods for analyzing safety data from various stages of drug development, post-marketing safety surveillance, and real world will be presented. Additionally, strategies on how to use the totality of information to generate evidence will be discussed.

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

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