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Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
The United Nations Sustainable Development Goals (SDG) call all UN member states– low-, high- and middle-income – to promote prosperity while protecting the environment. The 17 goals are part “of a shared blueprint for peace and prosperity for…
The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…
NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…
The Good Writing Practice initiative was launched in the December 2010 issue of TWS1 by Alistair Reeves and Wendy Kingdom. The aim is to go beyond the classic style guide and provide advice on practical aspects of writing that make texts easier to…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
As many of you are already familiar, Medical Writing began as The Write Stuff, a publication written by and for EMWA members. One of the goals in making the transition to Medical Writing was that it would become an international journal with readers…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in 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.
Medical Writing is listed in the following indexes:
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Victoria White
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My First Medical Writing
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
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