Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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

Session Chair(s)

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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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

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