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Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

English Grammar and Style - Volume 21, Issue

Pleasing the reader The fundamental principle in the practice of medicine, ‘first, do no harm’, could be transposed to the world of medical writing to ‘first, do not annoy’. The Good Writing Practice (GWP) group at EMWA has been focussing on…

Regulatory Writing - Volume 21, Issue

The European Medicines Agency looks to the future At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Responding to concerns over the PSMF: Inspectors offer key insights - Volume 23, Issue

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…

Getting what you want from your scientific writing: tips for writing clearly - Volume 21, Issue

Good medical writing is like good writing in any discipline: the writer should explain complex concepts and ideas clearly and accurately and engage the reader. In this article, I provide four suggestions to help clarify writing on complex subjects:…

Pesticide dossiers, an opportunity for medical writers - Volume 23, Issue

Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a…

Writing bioanalytical reports - Volume 23, Issue

Bioanalytical reports are usually written by bioanalysts. Medical writers offer a valuable contribution to bioanalytical reporting, increasing the efficiency of document development and improving the quality of data presentation. This article…

Medical Devices - Volume 29, Issue

The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…

Jumping over and through the obstacles: Navigating the freelance landscape - Volume 32, Issue

This article explores the major challenges and strategies for succeeding as a freelance medical writer. It covers several topics, including finding enough work, managing heavy workloads, ensuring document quality, and carving out time for…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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