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Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Scientific and medical publications are the pulse of the clinical world and play a key role in disseminating data to healthcare providers, scientists, and researchers. However, the process of publishing is hampered by the lack of harmonisation in…
Welcome to the Translation Section editorial! The Italian word Itangliano means Italian that is very much influenced by the English language and most of all it refers to the great presence of English words that are not adapted into Italian.…
In medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and time-consuming process of the…
A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
Pronouns are useful referents (i.e. the thing doing the referring) to avoid repetition of words (usually nouns). Although personal pronouns (he, she, and I, in particular) are infrequent in medical writing, the neutral ‘it’ and the demonstrative…
Dear MEW reader Welcome to the first 2012 Medical Writing or MEW issue – another EMWA milestone to start off this stellar year. I hope you enjoy the new design and the thematic focus on oncology. The theme of EMWA's upcoming 34th Spring conference…
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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