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A Practical Guide to Producing and Maintaining the PSMF




London, United Kingdom


05 Jul 2018

Reference No: T1802262-MFM

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Event Description

Course Outline:

The new pharmacovigilance legislation of 2012 now requires companies to provide a PSMF and that this document should be ‘Inspections ready’. If this is not done correctly this can result in critical findings for the Company that could set back further product launches or event sanctions against the Company's existing products. Maintenance of the PSMF is also an important aspect for maintaining the Company's compliance and these are reviewed in Regulatory Inspections.

Topics to be covered Include:-

  • The Changeover from the DDPS to the PSMF
  • Production of the PSMF
  • Maintaining and Updating the PSMF
  • Maintaining the Annexes associated with the PSMF
  • Control of the PSMF

Where & When?

5 July 2018

Cavendish Hotel
London, UK


 GBP 699
 EUR 979
 USD 1,090

GBP Price excludes VAT @ 20%


An Introduction to PSMFs

  • The DDPS
  • Converting the DDPS to the PSMF
  • Requirements for the PSMF
  • Declarations for the PSMF

The Content of the PSMF

  • The PSMF template
  • The detail in the PSMF
  • Preparation of the Annexes
  • The PSMF Log Book

The Sections of the PSMF

  • Section on the EU QP PV
  • Sources of Safety Data
  • IT & Databases
  • Regulatory timeline compliance
  • The PSMF processes
  • Testing of Quality in the PSMF
  • The Company Quality System

The Annexe requirements for the PSMF

  • The Company Product List
  • The EU QP PV list of delegated tasks
  • The list of SOPs and procedures
  • List of delegated activities to Third party partners
  • A List Of Completed Audits And Schedules
  • A List Of Performance Indicators For The PSMF Section
  • The roles and responsibilities of the EU QP PV
  • Master File number and version changes
Applicant Requirements
  • Anyone requiring a comprehensive overview of the Pharmacovigilance function and duties
  • Those who are responsible in Pharmacovigilance for any safety assessments and writing such plans including any EU QP PVs who approve such documents
  • Those who work with pharmacovigilance, e.g. Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality and IT that must sign off such documents
Reference No: T1802262-MFM
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