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Boston Convention and Exhibition Center

23 jun 2013 8:30 a.m. - 27 jun 2013 12:45 p.m.

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Session Chair(s)

Stuart Russel Walker, PHD

Stuart Russel Walker, PHD

Professor and Consultant

Centre for Innovation In Regulatory Science (CIRS), United Kingdom

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)

James  Leong, PHD, MPHARM

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)

Nate C. Blevins, MS

PDUFA V Implementation Plan for a Structured Approach to Benefit-risk Assessment

Nate C. Blevins, MS

GlaxoSmithKline, United States

R&D IT Program Manager

Lawrence  Phillips, PHD

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

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