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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,…
Welcome to the first OOOO of 2012. Let us start with Tool Box where Julia Powell gives us a review of Toggl, a handy desktop time tracking tool to help us measure our productivity. Then, Anu brings us another brain-teasing medical writing jumble.
New medical writers and medical writing students are often unsure how to start writing a manuscript and need help organising their thoughts. How to link the sections and information within them is what I call ‘manuscript flow’. This article is the…
At the start of a medical writing career, the quality control (QC) step can fill writers with a sense of dread. Someone is holding a magnifying glass to your carefully crafted (and at this point deeply loved) document and is trying to pick holes in…
New medical writers and medical writing students are often unsure how to start writing a manuscript and need help in organizing their thoughts. This is the third in a series of articles that explain how to link the sections and the information…
Getting started writing a manuscript – or any other document for that matter – can be difficult. Manuscripts are large projects, sometimes taking hundreds of hours and many months to complete. Faced with a blank page or screen, one might be tempted…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
Maria asked: “Write an article about editing for non-native speaking medical writers. … does not need to be long, and preferably ‘lightly’written. … [with] funny but at the same time educational stories to share in Lingua Franca…”
The Pharmacovigilance section of this issue is related to the first Meet & Share online event held in December 2021 by the EMWA Pharma - covigilance Special Interest Group (PV SIG) – with more than 70 attendees! Tiziana von Bruchhausen (editor)
A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations Definitions CTD – Common Technical Document (dossier submitted for marketing authorization) eCTD – Electronic Common Technical Document QC – Quality…
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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