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In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…
Only one university in the USA offers an undergraduate degree programme in medical writing. Worldwide, fewer than 10 institutions offer advanced degrees (Table 1). Over the past 14 years, I have read and edited many research papers, grant…
The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…
A successful medical writer needs to be an excellent time manager, communicator, and team player, and show great attention to detail and commercial awareness, in addition to possessing core writing skills and the ability to evaluate and…
Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…
Observational studies pose a number of biostatistical challenges. Methodological approaches have grown exponentially, but most are rarely applied in the real world. The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative…
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…
In 2004, health technology assessment (HTA) was recognised as a ‘political priority’ by the EC and Council of Ministers, which led to a call to establish an effective and sustainable European network for HTA (EUnetHTA). The result was the…
Is “creative medical writing” an oxymoron? I sincerely hope not! Indeed, if this is the case I will be sorely disappointed, as it is a career I wish to pursue precisely because it may allow me to exercise some creativity. I enjoyed both the arts and…
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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AI/Automation
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My First Medical Writing
News from the EMA
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
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Chris Monk