Drug Safety and Pharmacovigilance Across the Product Lifecycle
Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.
Session 13: Post-Marketing Safety Regulations – US
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will cover the FDA requirements for safety reporting for marketed products including prescription products, Abbreviated applications and complaint files as well as nonprescription (OTC) and dietary supplements.