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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 17: Audits and Inspections, Pharmacovigilance System Master File (PSMF)

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 focus on PV inspection readiness, audits and inspections and observations/findings. In addition, a review of the format and content of a PSMF will be discussed.

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