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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 18: FDA Warning Letters

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

  • Adjunct Assistant Professor
  • Rutgers, the State University of New Jersey, United States
A review of recent findings from several FDA Post-Marketing Adverse Drug Experience inspections will be discussed using Warning Letters to identify observations.

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