×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?
Session Chair(s)
Stuart Russel Walker, PhD
Professor and Consultant
Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Quantitative Benefit-risk Assessment: Where Are We Now, Why the Resistance and Where Are We Going?
Learning Objective : Evaluate the progress on the implementation of benefit-risk methodologies within companies and agencies; Discuss assessing relative importance (weighting) and uncertainty within the context of making explicit benefit-risk decisions and how these should be approached within the framework.
Speaker(s)
Benefit-Risk Framework Study: Can This Improve Regulatory Decision Making?
James Leong, PhD, MPharm
Duke NUS Medical School, Singapore
Head,Health Products & Regulatory Science Centre of Regulatory Excellence (CoRE)
PDUFA V Implementation Plan for a Structured Approach to Benefit-risk Assessment
Nate C. Blevins, MS
GlaxoSmithKline, United States
R&D IT Program Manager
Quantitative Benefit-risk Assessment: Where Are We Now, Why the Resistance and Where Are We Going?
Lawrence Phillips, PhD
London School of Economics, United Kingdom
Emeritus Professor of Decision Sciences, Department of Management
Have an account?