Pharmacovigilance System Master File

  • Thu 27 Jun 2019
  • All Day

Date of next meeting: 27th June, 2019
Venue: Holiday Inn, Egerton Road, Guildford, Surrey, GU2 7XZ
Cost: £350 + VAT

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

This course is led by John Barber, Head of Pharmacovigilance - European Operations at Dr. Reddy's Laboratories (UK) and facilitated by Dora Amene, Drug Safety Officer, Reckitt Benckiser UK Commercial Ltd and Gretel Sakyi.

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



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