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Benefit-Risk Assessments of Medicines: Framework Development and Use in Marketing Applications
Session Chair(s)
Nancy Pire Smerkanich, DRSC, MS
Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States
Benefit-Risk Assessment of Medicines: Past, Present and Future
Learning Objective : Identify global efforts in creating frameworks for a benefit-risk assessment; Describe qualitative and quantitative methods being used by regulators; Discuss how industry is addressing these needs from an operational perspective.
Speaker(s)
Stuart Russel Walker, PHD
Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Benefit-Risk Assessment of Medicines: Past, Present and Future
James Leong, PHD, MPHARM
Head,Health Products & Regulatory Science Centre of Regulatory Excellence (CoRE), Duke NUS Medical School, Singapore
A Regulator's Perspective of Benefit-Risk Frameworks
Marilyn A. Metcalf, PHD
Senior Director, Patient Focused Development, Global Medical, GlaxoSmithKline, United States
An Industry Representative's Perspective of Implementation of Benefit-Risk Frameworks
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