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Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics
Session Chair(s)
Graham Thompson
Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER
FDA, United States
FDA currently uses a structured, qualitative framework for benefit-risk assessment of human drugs and biologics. This session will cover FDA’s efforts to enhance this qualitative framework and explore more advanced benefit-risk assessment methods.
Learning Objective : Describe FDA’s approach to benefit-risk assessment under PDUFA V and VI; Discuss efforts to continue enhancing FDA’s methodological approach to benefit-risk assessment; Summarize findings from analysis of BRFs in 2017 novel drug approvals.
Speaker(s)
Implementation of a Structured Benefit-Risk Framework into FDA's Human Drug Review
Leila Grace Lackey, MHS, PHD
FDA, United States
Program Lead, Decision Support Service, OPSA, OSP, CDER
CBER’s Experience with Benefit-Risk
Hong Yang, PHD
FDA, United States
Biologist, OBPV, CBER
Planning and Assessing Benefit-Risk Quantitatively in the Next Decade
Susan Mayo, MS
FDA, United States
Senior Mathematical Statistician, CDER Office of Biostatistics
Best Practices for Quantitative Benefit-Risk Assessments
Tommi Tervonen
Kielo Research, Switzerland
Managing Director and Chief Scientist