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Whether you’re an early adopter, an occasional user, or yet to acknowledge its transformative potential, artificial intelligence (AI) – specifically generative AI applications underpinned by large language models – is undeniably shaping our present…
This paper provides an overview of contemporary medical illustration; the role of the modern medical illustrator is examined, including who they are likely to work for and with, as well as the range of media and technology employed. The…
November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency…
Critical thinking is necessary to edit a scientific article. However, in addition to questions about the language, we can also question the assumptions, documentation, and implications of the research, in a process I call “analytical editing.” A…
An environmental risk assessment (ERA) is the process of evaluating the effects of drugs for human use on the environment. ERAs must accompany all new drug market authorisations in Europe. In this article, we discuss the current guidelines on ERAs…
The EMWA Executive Committee and Head Office closely monitored the rapidly evolving implications of the current COVID-19 situation and the recommendations from the World Health Organization as well as the advice from and restrictions implemented by…
Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…
As a medical writer, can or should I be listed as an author of an article? For manuscripts, medical writers often go far beyond providing basic services and therefore may feel entitled to authorship. Medical writers are often the main force behind…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity 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.
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