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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, an overview of pharmacovigilance, pharmacoepidemiology, pharmaceutical risk management, and medication error prevention.
Speaker(s)
Linda Belmont, DDS, DO, MD
Project Coordinator, Learning & Digital Solutions, DIAA, United States
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Postmarketing Drug Safety at FDA
Claudia Manzo, PHARMD
Head of the Office of Risk Management, Pharmacovigilance and Patient Safety, AbbVie, United States
REMS Update
Chrissy Cochran, PHD
Director, Office of Bioresearch Monitoring Operations, ORA, FDA, United States
REMS Compliance
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