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Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Inclusive language in medical texts and medical translation in French - Volume 33, Issue

In French, the grammatical rule of the generic masculine, known as neutral, reveals a patriarchal worldview. This article looks at the consequences of this way of writing in medical texts and in medical translation. It also gives suggestions on how…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

Lay writing: Strategies for improving assent forms - Volume 27, Issue

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…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Medical journalism in a new era - Volume 30, Issue

We are living at a time when the general public is increasingly interested in scientific and medical advances. Medical journalism is therefore becoming more important to medical writers, although it is a subject that few of us are familiar with. To…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

Unlocking success as a book author: Navigating the essential social skills of writing gained through my PhD journey - Volume 33, Issue

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…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…

The ethics of medical translation - Volume 33, Issue

Much has been written about the ethics of medical interpreting, but not so much about purely written translation. What moral principles apply (or should apply) when I translate a document for a client? Do I need to invent these principles myself, or…

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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.

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