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The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
Many people do not take their medicines as prescribed, and medicines can cause harm if not used appropriately. In addition, in most health systems there is increasing discussion about involving patients in decisions about their health – including…
Increasing amounts of information are being made available to patients – but how do we know if we are getting it right and meeting people's needs? In this article, we describe how we have employed user testing to test and improve not just…
Dear EMWA Members, When we surged en masse onto the dance floor at the Dublin Conference Spring Dinner, supercool ceilidh band ‘Perfect Friction’ were astonished, wondering ‘…what are these medical writers all about?’ We certainly breathed life…
Welcome to the first issue of medical writing in 2015 on plain language, which means that this message had better be simple and easy to read. I am a huge advocate of plain writing and, as a Publication Manager, spend much of my time working with…
A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations Definitions CTD – Common Technical Document (dossier submitted for marketing authorization) eCTD – Electronic Common Technical Document QC – Quality…
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…
‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…
This is a report of our experience with a predatory journal that invited us to join them after having seen our winning essays on how to identify predatory journals. We applied the system we recommended therein to investigate the true nature of the…
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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