Pharmacovigilance System Master File (PSMF)

Pharmacovigilance System Master File (PSMF)

Date of next meeting: 27th June, 2019
Booking now closed

This intermediate / advanced course has been designed for anyone involved in compiling and maintaining the PSMF.

This course is led by John Barber, Managing Director and Lead Consultant, Plain Pharma Consultancy Ltd and facilitated by Dora Amene, PV Manager, TMC Pharma and Gretel Sakyi, Medical Information and Patient Safety Manager (Contract), Gretel Sakyi Ltd.


The agenda includes:

  • History & evolution of the PSMF 
    • Background discussion into how the PSMF came to be.
    • Discussion of previous equivalent documents
  • What is the PSMF & what is the legislation? 
    • An overview of the current EU legislation regarding  the PSMF
    • The PSMF and the rest of the world
    • Brief introduction to the structure of the PSMF
  • Structure of the PSMF
    • An overview of the structure of the body of the PSMF
  • Workshop 1 - Considerations for drafting a PSMF module
  • PSMF Annexes and PSMF Maintenance
    • Discussion about strategies to maintain and update various sections of the PSMF to ensure the document is reflective of the PV system.
  • Workshop 2 - Considerations for drafting an annex
  •  Inspection Findings related to the PSMF  
    • Discussion of some of the inspection findngs and deficiencies related to the structure and maintenance of the PSMF.
  • Workshop 3 – PSMF SOP & Challenges
    • Strategies for planning, writing, maintaining and updating the PSMF.
    • Draft the structure of a PSMF SOP and discuss the critical points that should be included.

Target audience: Anyone involved in compiling and maintaining the PSMF




Time: 1 day face to face course


Level of difficulty: Intermediate / advanced