Medical Writing Post-Approval Regulatory Writing Responding to concerns over the PSMF: Inspectors offer key insights

Volume 23, Issue 4 - Post-Approval Regulatory Writing

Responding to concerns over the PSMF: Inspectors offer key insights

Author: Dakshayini Kulkarni

Abstract

The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the marketing authorisation holder for their authorised medicinal products. The PSMF is intended to be a live, custom-made document that accurately reflects the pharmacovigilance system put in place for a given product. It is expected to contain meticulous detail so that the marketing authorisation holder's compliance with current good pharmacovigilance practices guidelines can be assessed. This article focuses on the feedback provided by the inspectors during their assessment of the PMSF with an emphasis on areas for improvement.

Keywords: PSMF, Inspection findings, Metrics
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References

  1. EMA. Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file, EMA/816573/2011 Rev 1 [updated 2013 Apr 9; cited 2014 Jul 28]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129133.pdf

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Post-approval regulatory writing
President's Message
Responding to concerns over the PSMF: Inspectors offer key insights
Post-approval regulatory writing – How different is it from writing pre-approval documents?
Strategic medical writing in the post-authorisation phase
Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
Writing publications for advisory boards
The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting
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