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With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
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…
It fills me with sadness that we had to cancel our spring face-to-face (F2F) conference in Riga. It’s been 1 ½ years since our last in-person meeting! Yet we hope that we at least will have the chance to meet in Cascais this autumn. But I also have…
Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…
The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…
Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…
One of the most challenging aspects of the COVID-19 pandemic has been remote education. Instructors and students, from primary grades to university level to professional training forums, have struggled to teach and learn synchronously online. Here,…
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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