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This article explores the journey of transitioning from PhD to a book author, emphasising the importance of soft skills cultivated during academic pursuits. Drawing from personal experience, the author underscores the parallels between academia and a…
Clinical trial protocol development forms part of the critical path for launching a trial, which means timelines are tight and progress must be fast and sustained throughout the protocol’s development. In order to be successful, medical writers…
Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…
Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
Before the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA), there was the Mississippi Valley Medical Editors Association (MVMEA). Most medical writers are unaware of the history of MVMEA and of how it…
Section Editor: Adriana Rocha Navigating my freelance journey while driving EMWA freelance activities Author: Laura A. Kehoe I didn’t plan to become a medical writer, but then again who does? It wasn’t, at the time, a career on the list of things…
The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) recognise the challenges to scientific publishing being posed by predatory…
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…
Section Editor: Evguenia Alechine I’m glad to be sharing the work of a rising star in the medical writing and science communication world. On this occasion, I had the pleasure of working with Valentina Torres Monserrat, who has a degree in…
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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