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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…
Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…
The recent publication of the book Bad Pharma by Ben Goldacre1 has caused quite a stir in the medical writing community (and indeed throughout the pharmaceutical industry).
Our publication, Medical Writing, has always been a work in progress, continually evolving to meet our members’ needs and desires. Originally a four-page newsletter called the EMWA Newsletter, it was renamed The Write Stuff in 1998 and, under the…
The ability to write up results and contribute to the medical literature is an important skill in a number of professions, including pharmacy practice. Some pharmacy residency programmes require that their participants produce a manuscript of…
A wintry London in January saw the release of the first joint position statement on the role ofthe professional medical writer (page 7). But why do we need such a statement and what does it say? The Executive Committee identified the need to update…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
The European Medicines Agency looks to the future At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According…
Digitalisation within the healthcare sector, particularly in long-term care, comes with implementation problems. Accepting digitalisation in caregiving as patient and healthcare professional depends on the understanding of the scope and application…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
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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