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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)

Sylvie  Tomczyk, MD, PHD

Sylvie Tomczyk, MD, PHD

Senior Medical Director

EMD Serono, United States

Speaker(s)

Michael  Keatley

Overview of Premarketing Safety Reporting Obligations in the US

Michael Keatley

Janssen Scientific Affairs, LLC, United States

Director, Local Safety Officer

Vicki  Edwards, RPH

Overview of Premarketing Safety Reporting Obligations in Europe

Vicki Edwards, RPH

Abbvie, United Kingdom

Vice President, Pharmacovigilance Excellence and International QPPV

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