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FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review
Session Chair(s)
![Graham Thompson](/_Images/member/Generic_Image_Missing-Profile.jpg)
Graham Thompson
Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER
FDA, United States
FDA will present an overview of considerations on benefit-risk assessment across the drug development lifecycle and solicit input from session attendees.
Learning Objective : Explain FDA’s approach to benefit-risk assessment throughout the lifecycle of drug development; Identify important milestones along the drug development lifecycle for communication between FDA and stakeholders on key considerations for regulatory benefit-risk assessment; Describe how early planning should be considered to collect data that may inform benefit-risk assessment.
Speaker(s)
Key Considerations and Patient Experience
Kerry Jo Lee, MD
FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro
![Gregory Levin, PhD](/_Images/member/Generic_Image_Missing-Profile.jpg)
Benefit-Risk Planning and Statistical Considerations
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Post Market Benefit-Risk Considerations
Judith Zander, MD
FDA , United States
Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
Additional Analysis to Inform Benefit-Risk Assessment
Hong Yang, PhD
FDA, United States
Biologist, OBPV, CBER
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