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President’s Message - Volume 27, Issue

In the apparently quiet time after the spring conference in Barcelona, much has been going on in the background of the association’s life. Before moving to the details of our activities, I would like to mention that two veteran members of the Head…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

Abstracts from the EMWA Spring Conference Poster Session - Volume 25, Issue

At this year’s Spring Conference, EMWA was delighted to introduce a poster session. There was a wide variety of posters available – all relating to aspects of medical writing or of relevance to medical writers. The poster session is an excellent…

ICMJE to mandate data sharing statements - Volume 26, Issue

Those of us who attended the 2017 spring conference in Birmingham were treated to an excellent symposium on transparency in clinical trials, where EU Policy 00701 on disclosure of clinical data was a key focus. A month later, theICMJE (International…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Lingua Franca and Beyond - Volume 25, Issue

Authors and co-authors This issue of Medical Writing is about Authors and Authorship, a topic, which despite stringent rules and regulations is sensitive, culturally-dependent and often full of emotion. I guess that we could have endless…

In the Bookstores - Volume 24, Issue

Statistical Thinking for Non-Statisticians in Drug Regulation (Second Edition) By John Wiley & Sons, 2014. ISBN: 978-1-118-47094-7 (hardcover).59.99 GBP. 368 pages. Writing for Science Journals: Tips, Tricks, and a Learning Plan By Geoff…

Medical Devices - Volume 29, Issue

May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…

Veterinary Medical Writing - Volume 29, Issue

All three articles in this Veterinary Medical Writing section were written when COVID-19 was not classified as a pandemic. Yet all three articles tie into the current narrative of regulation in veterinary medicine and the need for communication…

Is exercise physiology a real science? - Volume 21, Issue

Exercise physiology has not always been held with the same regard as other scientific disciplines. Despite the often held view that it is confined to the study of sport, exercise physiology has contributed to some of the most important scientific…

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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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