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Foreword: Writing for Patients, Foreword from the EMA - Volume 29, Issue

In recent years, regulators across the globe have improved the way they communicate to patients and the general public about their activities and how medicines are regulated.

The use of machine translation and AI in medical translation: pros and cons - Volume 33, Issue

In this article, I provide a retrospective look at the emergence of translation technologies and summarise the pros and cons of the use of neural machine translation and generative AI tools in medical translation. I will examine both the advantages…

Gained in Translation - Volume 24, Issue

We often write articles to satisfy two states of mind: pleasure and curiosity. In my case, this means the curiosity to delve into some of the intricacies of translation on the one hand, and, on the other, the desire to work together with colleagues…

Gained in Translation - Volume 28, Issue

I think going from actual medical writing to translation or vice versa is not a one-way street but an avenue. On a personal level, I think that translating goes hand in hand with being bilingual, or trilingual as I am now with Spanish, English, and…

The Webscout - Volume 25, Issue

Medical Communications ‘Medical Communications’ is an unspecific term. Sometimes it is used only to describe publications, medical education, and public relations; sometimes it also includes regulatory writing and advertising.

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Medical writing in the Middle East - Volume 22, Issue

Medical researchers in Middle Eastern countries have been forced to confront the fact that scientific publication has become the cornerstone of knowledge dissemination and academic promotion. Regional initiatives, such as the foundation of the…

Your professional association: A great way to expand your skills and advance your career - Volume 22, Issue

Many medical writers and translators are not members of professional associations. While online networking is clearly accepted as a key element for success in business, the benefits of joining associations are still not obvious to all, even though…

Regulatory pathways for development and submission activities - Volume 28, Issue

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…

Regulatory Writing - Volume 21, Issue

The European Medicines Agency looks to the future At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According…

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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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