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Circumlocution is the usage of a multiword structure instead of a shorter syntactic unit, for example, usage of a clause instead of a phrase. The distraction consequence of circumlocution can be sentence pattern disruption and unintended…
This section provides important updates in the evolving world of the complex writing environment for regulatory medical writers. Medical Writing. 2025;34(2):100–106. https://doi.org/10.56012/qbev3223
A lot was going on from April to June this year. Certainly the main event was our spring conference in Munich. Aside the established workshops, Freelance Business Forum, Expert Seminar Series, and updates on Special Interest Groups – it included an…
Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…
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…
Although content is obviously important for effective documents, the look of a document is also important. If you want someone to read a document, it should be pleasant to look at, and if you want the document to be used, the information should be…
Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…
“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No.…
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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