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Session 6: Safety and Benefit-Risk Assessment
Session Chair(s)
William Wang, PhD
President
Merck & Co, Inc, United States
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
Gregory Levin, PhD
Associate Director for Statistical Science and Policy, OB, OTS, CDER
FDA, United States
Several documents, such as the International Conference on Harmonization (ICH) M4E (R2) and ICH E2 series give guidance on what should be included in safety and benefit risk assessments for new drug applications and post marketing evaluation. These documents set good objectives for safety and benefit-risk evaluation during drug development. How to achieve these goals is an active topic of discussion for regulators and drug developers. This session will focus on the current regulatory landscape, industry practice and emerging trends for safety and benefit risk evaluation throughout the drug development life cycle, with a particular focus on improved planning.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Discuss FDA’s benefit-risk initiatives
- Identify ways that safety and benefit-risk planning can be improved
- Describe key features of program-wide safety and benefit-risk evaluation planning
Speaker(s)
Benefit-Risk Assessment Along the Product Lifecycle
Sara L. Eggers, PhD
FDA, United States
Director, Decision Support and Analysis Team, OSP, CDER
Improved Safety and Benefit-Risk Planning
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Aggregate Safety and Benefit-Risk Assessment Planning: Multi-Disciplinary Approach
Lothar Tremmel, PhD
CSL Behring, United States
Vice President, Quantitative Clinical Sciences and Reporting
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