Tutorial Instructors:

• Willemijn van der Spuij, Executive Director, Europe, World Wide Patient Safety, Bristol-Myers Squib
• Dionne Usher, Associate Director, Office of the Global QPPV, Merck Sharp & Dohme

MHRA regulator:

• Anastasia Daskajiannis St John, Pharmacovigilance inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

 Tutorial takes place on 18th November 2025 from 15:00-19:00 CET.

Since the PSMF was first introduced in the EU there has been a proliferation of requirements for PSMFs, or similar documents, in many countries globally. Additionally, technology has advanced and offers many opportunities to streamline management of the PSMF.

This practical, and interactive workshop is aimed at PSMF Managers, co-ordinators and/or staff involved in the creation/maintenance of the PSMF at the country, regional or global level. It will be beneficial to those who are new to the role and/or those who would like to refresh their knowledge on the PSMF.

The workshop aims to share concepts and practical approaches that will allow participants to come away with pragmatic ways of working and managing their PSMFs for multiple countries/regions. Small discussions groups, led by industry representatives, will focus on various topics such as: PSMF process, Systems (management as well as those that feed into the PSMF), and Audit and Inspection findings that may impact management of the PSMF and/or involve collaboration with multiple stakeholders who provide content for the PSMF.

The workshop respects confidentiality and proprietary information. Please come ready to share experiences and learnings so that all participants are better equipped to support creation and maintenance of the PSMF on a global basis.