A Practical Guide to Producing and Maintaining the PSMF & Annexes Training Course

This course provides a practical and comprehensive guide to the Pharmacovigilance System Master File (PSMF), a key regulatory requirement for all medicinal products authorised in the European Union. The PSMF plays a critical role in demonstrating how a company’s pharmacovigilance system operates and how compliance is maintained, making it a central focus during regulatory inspections.

Designed to support both new and experienced professionals, the course explores how to effectively plan, write, maintain, and update the PSMF in line with current regulatory expectations. It provides insight into the structure, level of detail required, and the importance of accurate and well-managed annexes in demonstrating compliance.

Participants will gain an understanding of how the PSMF integrates with wider pharmacovigilance systems, including quality management, audit processes, and regulatory timelines. The course also highlights the roles and responsibilities of key stakeholders, particularly the EU QPPV and Quality Assurance functions, in ensuring the PSMF remains accurate, up to date, and inspection-ready.

With a strong focus on real-world application, the training covers common inspection findings, regulatory expectations, and practical approaches to managing change control, audit trails, and system oversight. By the end of the course, attendees will be equipped with the knowledge and confidence to manage the PSMF effectively, support compliance, and respond to regulatory scrutiny.