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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)
Benefit-Risk Assessment of Medicines: Past, Present and Future
Stuart Russel Walker, PhD
Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor and Consultant
A Regulator's Perspective of Benefit-Risk Frameworks
James Leong, PhD, MPharm
Duke NUS Medical School, Singapore
Head,Health Products & Regulatory Science Centre of Regulatory Excellence (CoRE)
An Industry Representative's Perspective of Implementation of Benefit-Risk Frameworks
Marilyn A. Metcalf, PhD
GlaxoSmithKline, United States
Senior Director, Patient Focused Development, Global Medical
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