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HTA decision-making: Do ethics matter? - Volume 30, Issue

Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…

Medical Communication - Volume 22, Issue

Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

About the Medical Writing Journal - Volume 21, Issue

The official journal of the European Medical Writers Association (EMWA) has changed its name from The Write Stuff to Medical Writing, which is being published by Maney Publishing. This marks a leap forward for the journal, which is now in its 19th…

President's Message - Volume 24, Issue

Dear EMWA Members, When we surged en masse onto the dance floor at the Dublin Conference Spring Dinner, supercool ceilidh band ‘Perfect Friction’ were astonished, wondering ‘…what are these medical writers all about?’ We certainly breathed life…

Medical Communications and Writing for Patients - Volume 30, Issue

Dear All, In this edition of Medical Writing, I’m delighted to present an article from Vidhi Vashisht and colleagues on a subject very close to my heart – plain language summaries (PLSs). PLSs are summaries of clinical trial results written in a…

Medical Device Regulation: A necessary step towards more patient and user safety - Volume 26, Issue

Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…

Medical Communications and Writing for Patients - Volume 32, Issue

Editorial Section Editor: Lisa Chamberlain James Meet and Share session on protecting the public from undue harm during research studies: A report Author: Sampoorna Rappaz In September 2023, the Communicating with the Public Special Interest…

New documents required by the medical device regulation - Volume 29, Issue

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…

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…

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Scope

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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