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Leveraging Statistical Approaches in Drug Safety Analysis
Learning Objective : Describe key aspects in planning safety analyses, and their pivotal role in ensuring the safety of pharmaceutical products; Discuss regulatory considerations and best practices for presenting safety analyses to regulatory agencies; Identify quantitative assessment and characterization of adverse events of special interest (AESIs) in the drug lifecycle; Discuss the shortcomings of the way we currently estimate safety outcomes and a call to action to change that.
Speaker(s)
Leveraging Statistical Approaches in Drug Safety Analysis
Statistical Science Director, AstraZeneca, Sweden
Industry Update
Senior Director, Head Safety Statistics, AbbVie, United States
Industry Update
Head, Biostatistics, CSL Behring, United States
FDA Update
Senior Mathematical Statistician, OB, OTS, CDER , FDA, United States
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