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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. It may be of particular interest to 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.



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


EU Regulatory Authorities are visiting all licence holders to perform inspections on a Company’s compliance to Pharmacovigilance and the visits start with the assessment of the PSMF. This document provides the Regulators with not only the detailed assessment of the system but also the outputs from that system contained in the Annexes to gain an understanding of the Company compliance. The new Pharmacovigilance Legislation of 2012 now requires companies to provide a PSMF and that this document should be ‘Inspection ready’. If this is not done correctly this can result in critical findings for the Company that could set back further product launches or even sanctions against the Companys existing products. Maintenance of the PSMF also is an important aspect for maintaining the Company compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?




Leigh White

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