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This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…
The past two years have confronted humanity with a variety of unprecedented challenges due to the far-reaching COVID-19 pandemic. In response to this tragedy have come monumental new advances in science and technology – namely the vaccines developed…
Section Editors: Louisa Ludwig-Begall, Sarah Kabani How close are we to sustainability? Author: Catarina Leitão I have always loved nature. When I was a kid, I preferred watching wildlife documentaries to cartoons. Those documentaries taught me…
Since the infamous article by Wakefield et al. was published in 1998, diseases once nearly eradicated are re-emerging. As a result, research has focused on communication strategies that can successfully combat vaccine hesitancy. Current research…
Writing for lay audiences is recognised as a difficult task for medical writers, whose specialised knowledge can often hinder effective lay communication. This task is even more challenging when preparing clinical trial information for a…
Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
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…
The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…
NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…
Many pharmaceutical and medical device companies are making huge environmental, social, and governance (ESG) commitments, such as striving to achieve carbon neutrality, and aiming to reach diversity, equity, and inclusion (DEI) goals. In order to…
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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