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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, MD
DIA, United States
Project Coordinator, Learning & Digital Solutions
Postmarketing Drug Safety at FDA
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
REMS Update
Claudia Manzo, PharmD
FDA, United States
Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
REMS Compliance
Chrissy Cochran, PhD
FDA, United States
Director, Office of Bioresearch Monitoring Operations, ORA