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Benefit-Risk Assessments of Medicines: Framework Development and Use in Marketing Applications

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
363

Room Number:
6D

Level:
Intermediate

Type:
Forum

Title:
Benefit-Risk Assessments of Medicines: Framework Development and Use in Marketing Applications

Chair(s):
Nancy Pire Smerkanich
Educational Liaison/ Regulatory Science Doctoral Candidate
University of Southern California, United States

Description:
This forum will focus on the overarching benefit-risk frameworks that regulators and industry are using to make decisions concerning drug approvals. The role of how a common framework could meet the challenges of future drug development will also be discussed.


Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Benefit-Risk Assessment of Medicines: Past, Present and Future
Stuart Walker, PhD
Founder
Centre For Innovation In Regulatory Science (CIRS), United Kingdom

A Regulator's Perspective of Benefit-Risk Frameworks
James Leong, PhD, MPharm
Senior Regulatory Specialist
Health Sciences Authority (HSA), Singapore

An Industry Representative's Perspective of Implementation of Benefit-Risk Frameworks
Marilyn A. Metcalf, PhD
Senior Director, Benefit-Risk Evaluation
GlaxoSmithKline, United States