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Mandarin Oriental Washington D.C.

2017年1月23日 (月) 午前 7:30 - 2017年1月25日 (水) 午後 3:15

1330 Maryland Avenue, SW, Washington, DC 20024

Pharmacovigilance and Risk Management Strategies Conference

Session 2: FDA Updates

Session Chair(s)

Gerald  Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, CDER

FDA, United States

In this session, FDA representatives will provide updates from the Office of Surveillance and Epidemiology (OSE) within CDER. Topics will include postmarketing safety monitoring within OSE, overview of pharmacoepidemiology, pharmaceutical risk management, medication error prevention, and updates from the Office of Generic Drugs.

Speaker(s)

Gerald  Dal Pan, MD, MHS

Overview and FDA Updates

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

John  Peters, MD

Update from the Office of Generic Drugs

John Peters, MD

FDA, United States

Deputy Director, Office of Generic Drugs, CDER

Howard  Chazin, MD, MBA

Co-Presenter Update from the Office of Generic Drugs

Howard Chazin, MD, MBA

FDA, United States

Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER

Christian  Hampp, PHD, FISPE

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using EHRs

Christian Hampp, PHD, FISPE

Regeneron, United States

Senior Director, Pharmacoepidemiology

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