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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…
Having left the office for 5 days to go to the EMWA Spring Conference, I returned to the obligatory email avalanche. While it was mostly junk (and unfortunately still no ‘congratulations on winning the lottery’ message…), there were some messages…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
An image is worth a thousand words. This saying is easily disregarded as a cliché in today’s extremely visual world, but it may ring truer than ever. With the vast amounts of information reaching us every day, visualisations are increasingly…
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…
AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
The purpose of page layout is to consciously arrange text and graphics on a page in a way that supports the reading process and allows the reader to effortlessly follow the flow of information. It should blend words and images into an effective…
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 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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