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Session 3: FDA Safety Regulatory Updates
Session Chair(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Jamie Ridley Klucken, PHARMD, MBA, RPH
Safety Evaluator, Division of Pharmacovigilance, OSE, CDER, FDA, United States
In this session, FDA representatives within the Center for Drug Evaluation and Research (CDER) will provide updates on Risk Evaluation and Mitigation Strategies (REMS) from the Office of Surveillance and Epidemiology (OSE); updates on FDA draft guidances on the Benefit-Risk Assessment for New Drug and Biological Products for Industry (September 2021), and on Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (June 2021); and updates from the FDA’s Premarketing Safety Assessment Working Group on FDA Medical Queries (FMQs) from the Office of New Drugs (OND).
Learning Objective : - Identify advances in pharmacovigilance and risk management strategies, including REMS
- Examine the FDA assessment of emerging safety signals and review of safety data
- Discuss FDA draft guidances on benefit-risk assessment and safety reporting for IND bioavailability/bioequivalence studies
- Describe FDA MedDRA Queries and standard safety tables and figures
Speaker(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Speaker
Sara L. Eggers, PHD
Director, Decision Support and Analysis Team, OSP, CDER, FDA, United States
Speaker
Alyson Karesh, MD
Director, Division of Clinical Trial Quality, Office of Medical Policy, FDA, United States
Speaker
Scott Proestel, MD
Principal, Bethesda Pharmaceutical Consulting, LLC, United States
Speaker
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