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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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 25: Audits and Inspections, Pharmacovigilance System Master File (PSMF)

Session Chair(s)

Jill W. Buckley, PharmD

Be informed and stay engaged.