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Dear medical writers, Having embarked upon my year-long journey as president of EMWA, this is my first opportunity to update the members about the achievements, plans, and aspirations of the outgoing and new Executive Committee (EC). The…
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…
There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…
A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply of providers. The challenge that arises in such a…
On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…
Clinical writing, a specialised type of medical writing, refers to the types of writing health professionals use on a daily basis such as medical charts and forms. It requires knowledge of both formal and informal medical language and culture. An…
In recent years, a myriad of software has revolutionised the translation sector. This article presents a series of translation tools commonly used in the translation industry, depicting their main features and the way they have transformed the…
Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…
The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…
From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
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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Victoria White
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