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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)
Katarina Hedman
Statistical Science Director, AstraZeneca, Sweden
Leveraging Statistical Approaches in Drug Safety Analysis
Melvin Slaighter Munsaka, PHD, MED, MS
Senior Director, Head Safety Statistics, AbbVie, United States
Industry Update
Michael A. Fries, PHD, MA
Head, Biostatistics, CSL Behring, United States
Industry Update
Cesar Daniel Torres, PHD, MS
Senior Mathematical Statistician, OB, OTS, CDER , FDA, United States
FDA Update
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