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Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

News from the EMA - Volume 23, Issue

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…

Anonymisation: A new challenge for medical writers - Volume 27, Issue

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…

President's Message - Volume 25, Issue

Dear EMWA Members, Since my last message your committee have been busy on several initiatives. In November we held a very successful conference in Brussels with over 200 delegates. This provided 18 foundation and 10 advanced level workshops and an…

On educating the medical writer - Volume 22, Issue

Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…

Advance your medical writing career with essential soft skills - Volume 33, Issue

Medical writing demands a comprehensive set of technical skills, from mastering regulatory and ethical guidelines to honing exceptional writing abilities. The foundation of superior medical writing is built on the hard skills acquired through educati…

Lingua Franca and Beyond - Volume 25, Issue

In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…

The Webscout - Volume 22, Issue

There are different definitions of the adjective ‘good’, e.g. morally excellent; satisfactory in quality, quantity or degree; of high quality; excellent; well-behaved; etc. as the web dictionary tells us. In ‘good pharma’ the meaning of ‘good’ is…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

Journal Watch - Volume 21, Issue

Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…

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Scope

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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