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The use of artificial intelligence (AI) writing assistants in the healthcare industry is becoming increasingly prevalent. These tools can help medical writers to generate content more quickly and efficiently, but they also raise concerns about the…
Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…
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…
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…
Roseline Favresse is the Research Policy and Initiatives Director at the European Organisation for Rare Diseases (EURORDIS). We interviewed Roseline to learn more about the rare disease landscape within Europe and the exciting recent collaborations…
Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that 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…
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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