Webinar — Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

First impressions are everything, especially during a pharmacovigilance (PV) inspection. As the inspector’s primary entry point into an organisation’s PV system, the Pharmacovigilance System Master File (PSMF) is a critical demonstration of a Marketing Authorisation Holder’s governance, oversight, and commitment to patient safety, and can be leveraged to showcase continuous improvement in key areas.

For MAHs, the PSMF provides a transparent view of how PV responsibilities are structured, maintained, and overseen by the LPPV/QPPV. When effectively managed, it not only meets regulatory expectations but also evidences robust oversight, continuous improvement, and inspection readiness across the PV system.

Using real-world examples and practical insights, this webinar explores how the PSMF is assessed during PV inspections, common inspection findings, and how MAHs and LPPVs/QPPVs can proactively anticipate and address inspector expectations.

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