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Home>A Practical Guide to Producing and Maintaining the PSMF (London, United Kingdom - January 30, 2018) - Research and Markets

A Practical Guide to Producing and Maintaining the PSMF (London, United Kingdom - January 30, 2018) - Research and Markets

A Practical Guide to Producing and Maintaining the PSMF (London, United Kingdom - January 30, 2018) - Research and Markets

10/04/2017

A Practical Guide to Producing and Maintaining the PSMF (London, United Kingdom - January 30, 2018) - Research and Markets

The "A Practical Guide to Producing and Maintaining the PSMF" conference has been added to Research and Markets' offering.

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 Company's 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?

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

Agenda:

09.00 Registration and Coffee

09.30 Meeting

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