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Navigating the EMA clinical data website - Volume 27, Issue

This paper describes how to register, access, and navigate the EMA clinical data website. One of the authors (RB) is a medical writer and accessed the site from the perspective of a pharmaceutical industry professional. The other author (AS) is not…

Pharmacovigilance - Volume 31, Issue

The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…

Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Letter to the Editor - Volume 25, Issue

Dear Editor, EMWA and other organisations (eg, AMWA, ISMPP) support the principles of Good Public at - ion Practice (GPP). As a co-author of the recent GPP3 guideline1 and leader of the professional medical writer section, I was concerned by a…

Regulatory writing for rare disease: An interview with Kelley Hill - Volume 34, Issue

Over her 40-year career, Kelley Hill has become regarded as an industry expert in strategic, high-quality, and impactful regulatory writing, especially in the rare disease space. Now enjoying a slower pace of life having retired in 2023, she has led…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

How and why it works: The principles and history behind visual communication - Volume 29, Issue

"“A picture is worth a thousand words” – a familiar adage, and the reason why newspaper articles are commonly accompanied by photographs and infographics. Scientific publications are no different, so medical writers are frequently asked to…

AI/Automation - Volume 34, Issue

Section Editor: Daniela Kamir ChatGPT use among medical writers: A knowledge, attitude, and practices survey Authors: Simran Kaur Juneja, Shital Sarah Ahaley, Ankita Pandey, Sujatha Vijayakumar Medical Writing. 2025;34(2):87–97.…

Editorial - Volume 29, Issue

Data are economic assets that power the so-called fourth industrial revolution. The healthcare industry is at the forefront of this “data economy”. Medical writers should understand how to use these data appropriately and responsibly. This issue of…

Manuscript Writing - Volume 22, Issue

New medical writers and medical writing students are often unsure how to start writing a manuscript and need help organising their thoughts. How to link the sections and information within them is what I call ‘manuscript flow’. This article is the…

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Scope

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.

Medical Writing is listed in the following indexes: