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Session Chair(s)
Susan Mayo, MS
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA, United States
Learning Objective : Describe current international regulatory guidance for benefit-risk as it relates to clinical statisticians; Explain examples of benefit-risk methods from several perspectives; Discuss the need for more mature benefit-risk quantification methodologies. .
Speaker(s)
An Example of Benefit-risk Analysis Applying the BRAT Framework
Conny Berlin, MS
Novartis Pharma AG, Switzerland
IMI PREFER Project Leader & Global Head, Quantitative Safety and Epidemiology
A Regulator's View of Quantitative Benefit-risk Analysis
Jonathan D. Norton, PHD
FDA, United States
Mathematical Statistician, Division of Biometrics V, OB, OTS, CDER
Benefit-risk Evaluation: Concepts and Methods
Scott Evans, PHD, MS
George Washington University Milken Institute of Public Health, United States
Professor and Founding Chair, Department of Biostatistics and Bioinformatics
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