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This feature explores the authors experience in supporting researchers in low- and middle-income countries (LMICs). After years of honing her skills in both basic research and medical writing, Julie Chaccour transitioned into a position in research…
As I write this, 2020 is drawing to a close. Although it has been an enormously challenging year, I want to take a moment to recognise a high point – the successful completion of EMWA’s first virtual conference. What a milestone and major…
In May 2019 EMWA established a Sustainability Special Intrest Group (SUS SIG). The SUS SID aims to bring sustainability goals into EMWA as an organisation and helps disseminate information for medical writers and medical communicators on being more…
The Greek philosopher Heraclitus has been credited with the idea that there is nothing perma - nent except change. This certainly pertains to EMWA as we celebrate our 25th year. The first EMWA meeting in 1992 had 32 participants with no workshops.…
The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…
Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
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…
Mentorship is often viewed as a traditional personal relationship model, where the mentor meets face-to-face with a mentee within the same organisation or group. However, I have been mentoring medical writers success fully for many years using…
Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…
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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Alicia Brooks Waltman
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