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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review

Session Chair(s)

Graham  Thompson

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)

Kerry Jo  Lee, MD

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

Benefit-Risk Planning and Statistical Considerations

Gregory Levin, PhD

FDA, United States

Associate Director for Statistical Science and Policy, OB, OTS, CDER

Judith  Zander, MD

Post Market Benefit-Risk Considerations

Judith Zander, MD

FDA , United States

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER

Hong  Yang, PhD

Additional Analysis to Inform Benefit-Risk Assessment

Hong Yang, PhD

FDA, United States

Biologist, OBPV, CBER

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