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Regulatory Public Disclosure - Volume 32, Issue

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

Lingua Franca and Beyond - Volume 24, Issue

It is my real pleasure to welcome you to the second issue of Lingua Franca and Beyond, a regular feature of Medical Writing for non-native English speaking medical writers. As soon as I'd written those words, I realised that this section should not…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers - Volume 29, Issue

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…

Staying ahead of the game in the changing arena of ethical medical communications - Viewpoint of a freelance medical writer - Volume 25, Issue

Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…

Study design made easy - Volume 25, Issue

Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…

Medical writing for generics throughout the life cycle - Volume 28, Issue

Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…

Regulatory Writing: The essence of regulatory writing as defined by its jargon - Volume 23, Issue

In this issue of Medical Writing dedicated to regulatory writing, many of the articles provide some glimpses of the day-to-day problems and dilemmas faced by regulatory writers. It is hard, however, to describe the essence of regulatory writing in a…

Manuscript Writing - Volume 22, Issue

Getting started writing a manuscript – or any other document for that matter – can be difficult. Manuscripts are large projects, sometimes taking hundreds of hours and many months to complete. Faced with a blank page or screen, one might be tempted…

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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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