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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
Katarina Hedman
AstraZeneca, Sweden
Statistical Science Director
Industry Update
Melvin Slaighter Munsaka, PhD, MEd, MS
AbbVie, United States
Senior Director, Head Safety Statistics
Industry Update
Michael A. Fries, PhD, MA
CSL Behring, United States
Head, Biostatistics
FDA Update
Cesar Daniel Torres, PhD, MS
FDA, United States
Senior Mathematical Statistician, OB, OTS, CDER
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