Medical Writing Post-Approval Regulatory Writing Strategic medical writing in the post-authorisation phase

Volume 23, Issue 4 - Post-Approval Regulatory Writing

Strategic medical writing in the post-authorisation phase

Author: Sarah J. Richardson

Abstract

This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical writer. The strengthening of post-authorisation legislation has led to documents with new and improved formats. At the same time, the strategic medical writer's role has evolved almost in parallel with these legislative changes. The strategic medical writer contributes document and scientific expertise, writing skills, and project leadership through effective communication, and also provides an invaluable link in the team in the development of post-authorisation documents by anticipating problems, managing the review process, advising on data presentation, and ensuring compliance with guidelines. This process results in the production of high-quality documents, makes the submission process smoother, promotes the strengthening of the pharmacovigilance system, and ultimately contributes to patient safety.

Keywords: Post-authorisation documents, Legislation, Medical Writing, Pharmacovigilance
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