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Session 2: FDA Updates
Session Chair(s)
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)
Overview and FDA Updates
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Update from the Office of Generic Drugs
John Peters, MD
FDA, United States
Deputy Director, Office of Generic Drugs, CDER
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
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using EHRs
Christian Hampp, PhD
Regeneron, United States
Director, Pharmacoepidemiology
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