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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…
Medical communication publications are designed to raise awareness of medicines, cosmetics, and technology. These publications ensure that doctors are informed about the role of new and existing medicines and the literature concerning appropriate…
With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
Training medical writers has never been an easy task – there is a specific and demanding set of skills needed to tease out the crucial messages from data, manage stressed and pressured teams effectively, and keep up with the constant changes in the…
Making the first steps as a medical writer in the pharma and biotech industry can be challenging. Three general principles can help managers foster the growth and development of their team members: Reveal, Rebalance, and Release. Reveal means that…
As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…
ABSTRACT A round-up of news in the organisation. Medical Writing. 2023;32(4):10–11. https://doi.org/10.56012/oknc4756
A round-up of news in the organisation Medical Writing. 2024;33(1):10–11. https://doi.org/10.56012/bzjb4373
Dear Medical Writers Top of Form Bottom of Form I expect I am not the only one who at this time of year looks at their calendar in disbelief and asks how on earth another 12 months can have disappeared so quickly? The end of the year is always an…
We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…
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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