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Hyatt Regency Bethesda

2013 年 11 月 12 日 8:15 上午 - 2013 年 11 月 12 日 5:15 下午

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

Global AE Reporting: Drug Safety Requirements in the US and EU

Session Chair(s)

Andre  Daniels, MD, MS

Andre Daniels, MD, MS

Executive Director, Global Regulatory Affairs and Safety

Amgen, Inc., United States

Speaker(s)

Joanna  Haas, MD, MSC, FACP, FISPE

Detection, Evaluation, Mitigation and Reporting of Safety Issues through the Product Life Cycle

Joanna Haas, MD, MSC, FACP, FISPE

Haas and Partners LLC, United States

Founding Partner

J. Michael  Sprafka, PHD, MPH

The Growing Use of Observational Studies in Risk Management Strategy

J. Michael Sprafka, PHD, MPH

Amgen Inc., United States

Executive Director, General Medicine, Inflammation & Bone TA Lead

Paul J. Seligman, MD, MPH

Methods and Challenges in Evaluating Risk Management and Risk Minimization Programs

Paul J. Seligman, MD, MPH

Amgen Inc., United States

Executive Director, Global Regulatory and R&D Policy

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