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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

Session Chair(s)

Jill W. Buckley, PharmD

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.

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