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

About the Webinar

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 will explore how the PSMF is assessed during PV inspections, common inspection findings, and how MAHs and LPPVs/QPPVs can proactively anticipate and address inspector expectations.

By adopting a strategic approach to PSMF ownership and maintenance, organisations can transform this regulatory requirement into a powerful tool that reinforces accountability, compliance, and patient safety — setting the right tone from the very first inspection interaction.

What You’ll Learn

• The role of the EEA / UK PSMF during Pharmacovigilance Inspections
• MAH responsibilities and expectations for PSMF governance and oversight
• The role of the LPPV/QPPV in ensuring PSMF accuracy, compliance, and inspection readiness
• Examples of real-world PSMF inspection findings and regulatory observations
• Best practices for avoiding PSMF findings and demonstrating effective oversight
  

Who Should Attend 

• Marketing Authorisation Holders (MAHs)
• LPPVs / QPPVs and Deputy QPPVs
• Pharmacovigilance professionals across all PV functions
• Quality, compliance, and governance stakeholders involved in PSMF maintenance

The PSMF impacts everyone—and effective MAH and LPPV/QPPV oversight is central to its success.

Unable to join? Register and you will receive the recording after the live session.