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.
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk