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Event Details


A Practical Guide to Producing and Maintaining the PSMF

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Who should attend?

This course will be relevant for anyone requiring a comprehensive overview of the pharmacovigilance function and duties, particularly 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 and marketing, legal, commercial and quality must sign off such documents.


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





Leigh White

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