Pharmacovigilance System Master File (PSMF)

Date of next meeting: tbc
Cost: £250 + VAT

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.

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 and UK 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
    • The UK PSMF
  • 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.
  • Inspection Findings related to the PSMF  
    • Discussion of some of the inspection findings and deficiencies related to the structure and maintenance of the PSMF.

Target audience: 

Anyone involved in compiling and maintaining the PSMF


1 day face to face course

  Level of difficulty: 

Intermediate / advanced

    Register your Interest