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Aggregate Safety Assessment Planning and Estimands for Safety Evaluation in the context of COVID-19
Session Chair(s)
William Wang, PHD
Executive Director
Merck & Co, Inc, United States
Framing the right questions is a critical part of any scientific pursuit. Aggregate Safety Assessment Planning (ASAP) provides a structured and proactive framework to plan and execute on safety evaluation during the product development life cycle. Estimand framework in the ICH E9 R1 can help answer the right question with the right estimand to improve quality of safety and benefit-risk evaluation.
Learning Objective : • Understand how the estimand framework in the ICH E9 R1 may help get the questions right • Examine the proper estimation for the right estimand in the time to event analyses of advance events • Discuss the safety and benefit-risk assessment using estimand framework in the context of COVID-19 pandemic
Speaker(s)
Aggregate Safety Assessment Planning
Barbara Hendrickson, DrMed, MD
United States
Clinical Associate, Pediatric Infectious Diseases
Stop the Abuse: A Plea for a more Principled Approach to the Analysis of Adverse Events
Kaspar Rufibach, PHD, MSC
Roche, Switzerland
Expert Statistical Scientist, Methods, Collaboration, and Outreach Group
Panel Discussion: Estimated Framework and Safety/Benefit-risk Evaluation in the Context of COVID-10 Pandemic Panelist
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Director
Panelist
Jürgen Kübler, PHD
Quantitative Scientific Consulting, Germany
Owner
Panelist
Gregory Levin, PHD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER