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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)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Overview and FDA Updates
John Peters, MD
Deputy Director, Office of Generic Drugs, CDER, FDA, United States
Update from the Office of Generic Drugs
Howard Chazin, MD, MBA
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER, FDA, United States
Co-Presenter Update from the Office of Generic Drugs
Christian Hampp, PhD, FISPE
Senior Director, Pharmacoepidemiology, Regeneron, United States
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using EHRs
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