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Hyatt Regency Bethesda

Feb 10, 2014 8:15 AM - Feb 11, 2014 5:15 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Benefit-Risk Assessment from Inception to Maturation: Aligning Regulatory and Industry Goals

Session 7 - Panel Discussion

Session Chair(s)

Paul D. Huckle

Paul D. Huckle

Chief Regulatory Officer and Senior Vice President, Global Regulatory Affairs

GlaxoSmithKline, United States

This session will consist of an open discussion of critical topics. The audience will have the opportunity to ask leading industry and regulatory experts questions on benefit-risk assessment.

Speaker(s)

Robyn R. Lim, PhD

Panelists

Robyn R. Lim, PhD

Health Canada, Canada

Senior Science Advisor, Health Products and Food Branch

Bruno  Flamion, MD, PhD

Bruno Flamion, MD, PhD

Idorsia Pharmaceuticals Ltd, Switzerland

VP, Head Strategic Development

K. Kimberly  McCleary

K. Kimberly McCleary

The Kith Collective, LLC, United States

Founder and Chief Executive Officer

Andrea  Tan

Andrea Tan

FDA, United States

Operations Research Analyst, OSP, CDER

Robert  Ball, MD, MPH, MSc

Robert Ball, MD, MPH, MSc

FDA, United States

Deputy Director, Office of Surveillance and Epidemiology, CDER

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