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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 2 - Part 2: Evolving Expectations for Benefit-Risk

Session Chair(s)

Rebecca  Noel, DrPH, MPH

Rebecca Noel, DrPH, MPH

Executive Director, Benefit-Risk Assessment

Eli Lilly, United States

In this session, global regulatory and industry representatives will continue to discuss updates on the key benefit-risk initiatives. Participants will have the opportunity to pose questions to the presenters in a panel forum in this session.

Speaker(s)

Lawrence  Liberti, PHD, RAC

CIRS Initiative

Lawrence Liberti, PHD, RAC

The Kim Center/ USC DRQS, United States

Director, D.K. Kim International Center for Regulatory Science

Andrea  Tan

FDA Perspective

Andrea Tan

FDA, United States

Operations Research Analyst, OSP, CDER

Hans-Georg  Eichler, MD, MSC

Panelists

Hans-Georg Eichler, MD, MSC

Austrian Association of Social Security Bodies, Austria

Consulting Physician

Juhaeri  Juhaeri, PHD

Juhaeri Juhaeri, PHD

Sanofi, United States

Vice President and Global Head, Epidemiology and Benefit-Risk Evaluation

Robyn R. Lim, PHD

Robyn R. Lim, PHD

Health Canada, Canada

Senior Science Advisor, Health Products and Food Branch

Lawrence  Liberti, PHD, RAC

Lawrence Liberti, PHD, RAC

The Kim Center/ USC DRQS, United States

Director, D.K. Kim International Center for Regulatory Science

Andrea  Tan

Andrea Tan

FDA, United States

Operations Research Analyst, OSP, CDER

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