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The good news first: Patient-reported outcomes (PRO) are basically the same in both the medical device and the pharmaceutical sectors. There are the general quality of life tools such as the EQ-5D or the Short-Form Survey questionnaires (e.g. SF-12,…
The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…
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…
Observational studies pose a number of biostatistical challenges. Methodological approaches have grown exponentially, but most are rarely applied in the real world. The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative…
Decoding the Japanese Code 1: Yes means yes, and no does not exist At a recent dinner, my husband and I were chatting with a university professor, a Japanese fellow who has lived and worked in Europe and the US. We talked about cross-cultural…
The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) recognise the challenges to scientific publishing being posed by predatory…
Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…
"From the Editor-in-Chief: Journal Watch is the re-birth of a previous column edited by Nancy Milligan. We are happy to welcome Hervé Maisonneuve, MD as the new Section Editor for Journal Watch. Hervé is a contributing editor for several scientific…
Paragraphs are meant to make a text understandable and readable, and to help tell the story. Key aspects of good paragraphs include using topic sentences and story structures. Starting with an outline or a planand using it to build to topic…
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.…
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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