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.
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References
- 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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Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
- Clare (Chi-Chih) Chang
- Jonathan Pitt
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Beatrix Doerr
- Sam Hamilton (Newcastle Upon Tyne, UK)
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)