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EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…
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 –…
The rise of ”predatory journals”, also known as pseudo-scientific journals, poses a risk to the integrity of science and therefore medical communicators need to know about their practices. Upon receipt of a publication fee, predatory journals…
The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of…
The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…
Modern data legislation increasingly empowers citizens, and therefore patients, with rights to access and control their health data. The mechanisms needed to exercise modern data rights are currently underdeveloped and underserving individuals and…
Writing for lay audiences requires language that is understandable by readers without expertise in the subject matter at hand. This means carefully selecting, organising, wording, and supporting content, focusing on conveying relevant points in a…
Making the leap to become a freelancer is daunting enough, but once established how do we ensure our business has staying power? Thank you to our experienced freelancers who share their top tips for longevity. Never let it be said that OOOO is…
Dear EMWA Members, It is my very great pleasure to ‘speak’ to you from the pages of the very first issue of Medical Writing of 2016, with our new printer, Hastings. I am particularly excited that our feature articles are now open-access – a…
Dear Members I am sure you are all very familiar with this situation – sitting in front of a blank piece of paper (or to be more accurate a blank screen) and wondering where to start. Beginnings and endings always seem to be the trickiest part, but…
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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