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Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
Some more four-letter words I published a series of articles in The Write Stuff on short words frequently used in the medical and scientific context between Volume 16(3) 2007 and Volume 18(4) 2009. Since then, at training courses and in email…
Whoever writes wants to be read. Yet, even if we succeed in creating an informative, logically structured, and adequately worded text tailored to our target audience, i.e., text we consider to have an adequate level of readability, our documents may…
Greetings, readers.For freelancers, receiving feedback is an important process for building a mutually productive relationship with a client. Positive feedback serves to encourage and helps develop core strengths, while constructive criticism is…
Well here’s a sentence I never thought I’d write: In this issue we learn how the Argentine Tango can make us better writers. Really! When our contributor, Susanne Geercken, told me that this was the topic she’d chosen, I was both intrigued and…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
Continuing medical education (CME) in Germany, as in other countries, is an estab - lished instrument for the delivery of ongoing training in medicine. Since September 2004, Deutsches Ärzteblatt has published 155 CME papers, and, as of the 12th of…
It fills me with sadness that we had to cancel our spring face-to-face (F2F) conference in Riga. It’s been 1 ½ years since our last in-person meeting! Yet we hope that we at least will have the chance to meet in Cascais this autumn. But I also have…
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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