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Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
Section Editor: Nicole Bezuidenhout Traversing the social media landscape: Digital health communications in 2024 Author: Shannen Young Amidst a post-pandemic landscape marked by dis- and misinformation, new technologies, and platform shifts,…
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…
In Italy, little is known about the roles, activities, and compensation of medical writers and scientific communicators. A survey, tailored to local aspects and regulations, was conducted to capture a contemporary snapshot of the medical writing…
Section Editors: Louisa Ludwig-Begall, Sarah Kabani Saving the planet, one EMWA conference at a time Author: Adam Jacobs I had been a frequent business traveller for some years until not so long ago. Most of my trips were by plane. I would…
Dear EMWA Members, As you are well aware, we have been celebrating our 25th anniversary as an organisation and have sent out specially designed buttons with the December issue of Medical Writing to commem - orate the occasion. To continue the…
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…
In this data-driven era, the type and format of publicly available medical and scientific information is significantly changing. Medical writers can serve as guardians of the information entering the public domain by ensuring accuracy 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.
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