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Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

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.…

Out on Our Own - Volume 29, Issue

As I write this editorial, the coronavirus pandemic is having profound effects around the globe. In a time of uncertainty, stress, and fear, I try to think of the positives. For me, one positive is that I’m a freelancer. I have not lost any clients,…

Getting Your Foot in the Door - Volume 31, Issue

“Pharmacists can only work in pharmacy”. False! Prior to my studies in pharmacy, I thought so until I had an introductory course at the university and heard about many career opportunities after completing a diploma. Still, the lecturers stressed…

From the Editor - Volume 33, Issue

On multilingualism and medical writing I arrived in Europe in September 1991 and was completely unprepared for the multilingualism of this continent. My first European home was the bilingual city of Brussels in the trilingual country of Belgium.…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

HIV research fraudster handed stiff prison sentence - Volume 24, Issue

In the December 2014 issue of Medical Writing, I reported that disgraced Iowa State University researcher Dong-Pyou Han was facing fraud charges for faking experiments on a new HIV vaccine.1 In spite of a guilty plea, on 1 July 2015 Dr Han was…

In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

Out On Our Own - Volume 22, Issue

Editorial We hope that you enjoyed the summer months and found time to step away from your desks and relax. This time last year, Kath organised her first ‘Medical Writers’ Retreat’, the aim of which was to provide an opportunity for fellow…

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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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