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02-Jul-2019 - 02-Jul-2019

A Practical Guide to Producing and Maintaining the PSMF

  • Location:
    • Thurloe Place
    • London
    • Greater London
    • SW7 2RS
    • United Kingdom
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Course Overview

All EU regulatory pharmacovigilance Inspections start with the assessment of the PSMF. The PSMF provides the regulators with not only a detailed assessment of the system but the outputs from that system contained in the Annexes provide an understanding of a company’s compliance. This course will provide a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update. 

Topics to be covered include:

  • Production, maintaining and updating the PSMF
  • Maintaining the Annexes associated with the PSMF
  • Control of the PSMF including the EU QP PV and the XEVMPD
  • The PSMF and major changes
  • The PSMF audits and inspections