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This is the first systematic comparison of the costs of salaried and freelance medical writers working in Europe. In the absence of official figures for the total costs of employment, we make reasoned assumptions, using mean base figures for…
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
It is widely acknowledged that resolutions of difficulties tend to engender new problems. Increasingly, complex systems perpetuate increasing complexity. This discursive essay suggests that the most promising of discoveries, innovations, and…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…
To the Editor – I read the recent article on the fourth EMWA freelance business survey1 with great interest and some considerable concern. When freelance writers express an interest in working with Rx Communications, one of the first things we ask…
Medical writers are perceived by many health economists to be incompetent in health economics writing. Medical writers need to abolish this common perception, and so must develop an understanding of cost-effectiveness, cost-utility, and other health…
Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…
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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