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Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in…
Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…
The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available…
Preclinical studies –is animal testing necessary?The drug regulatory authorities require testing in animals, to be exact in at least two mammalian species, before the first-in-human trials can be approved. Common criticism is that the results from…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…
Greetings from the croft! I think it’s a neat coincidence that I have the pleasure to write my first editorial to this edition of The Crofter in the Medical Writing special issue on mentorship. I don’t have an official mentor but ever since I…
Something less beguiling for a horror-story addict than the emergence of obesity would be hard to imagine. Start by reading the 27 August 2011 issue of the Lancet. One article predicts that the obesity rate in the UK will make the tremendous leap fro…
Writing for online sources requires a slightly different skillset than writing for print publications. Authors need to be aware of their potential audience’s interests. This article explains how avoiding typical online mistakes, and both knowing and…
Section Editor: Maddy Dyer How medical writers can support patient authors of company-sponsored publications Authors: Phil Leventhal, Danielle Drachmann, Stephen Gilliver, Hui Zhang Medical Writing. 2025;34(2):116–120.…
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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