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The Chinese pharmaceutical regulatory landscape and medical publication policies have gone through drastic changes in recent years, and they continue to evolve. These changes provide great opportunities and many challenges to medical writers in…
These two years in the Executive Committee flew by. They will remain in my heart for ever. It is difficult to summarise the emotions and the things we accomplished these last two years. When this adventure started in Cyprus, Susan Bhatti, the…
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…
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…
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…
Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…
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…
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…
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)…
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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