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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…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
Although medical writing as a career has been around for a few decades, medical writing education is relatively new. Many medical writers end up teaching scientific or medical writing, and have built their courses and their teaching style without…
Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…
Welcome to the first issue of medical writing in 2015 on plain language, which means that this message had better be simple and easy to read. I am a huge advocate of plain writing and, as a Publication Manager, spend much of my time working with…
Professional medical writers have an important role in facilitating the accurate and timely dissemination of medical and scientific data. This support should be appropriately acknowledged in peer-reviewed publications, but guidance on how to…
Most medical writers cut their teeth on manuscripts, and these documents are often mistakenly believed to be ‘easy’ to write. However, the truth is that with all documents, they are easy to write badly but require skill and knowledge to write well.…
Communication, communication and even medical communication What is it about? Let’s start with the Wikipedia definition: “Communication (from Latin comm - ūnicāre, meaning ‘to share’) is the purposeful activity of information exchange between two…
Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…
The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…
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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