Since the introduction of the Pharmacovigilance System Master File (PSMF) in the EU, requirements for PSMFs (or equivalent documents) have steadily expanded across many regions globally. As a result, organisations are increasingly expected to manage multiple PSMFs across multiple countries and regions, often with differing regulatory expectations.

This practical and interactive workshop is designed for PSMF Managers, coordinators, and professionals involved in the creation, maintenance, and oversight of PSMFs at country, regional, and/or global level. It will be particularly valuable for those who are new to the role, as well as experienced users seeking to refresh their knowledge and exchange practical approaches.

Workshop Objectives and Format

The workshop aims to share pragmatic concepts and real-world approaches that participants can apply directly to the management of PSMFs across multiple countries and regions. The session will be delivered through focused discussion-based modules, led by experienced industry representatives who will facilitate interactive dialogue and exchange of experiences:

1. PSMF management in practice
• Experiences, operating models, and approaches to managing PSMFs across single and multiple regions.
2. Systems supporting the PSMF
• PSMF management systems and the key systems and data sources that feed into the various PSMF components.
3. PSMFs in audits and inspections
• Preparing the PSMF for audit and inspection readiness, managing provision to authorities, and handling outcomes and feedback.

Collaborative and Confidential Setting

The workshop is conducted in a confidential environment, respecting the proprietary nature of company-specific approaches and information. Participants are therefore expected to actively contribute their own experiences and learnings, with the understanding that information shared will remain confidential among attendees. This collaborative approach is intended to ensure that all participants leave the session better equipped to support the creation, maintenance, and global oversight of the PSMF within their organisations.