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Navigating the complex landscape of clinical trial transparency: What medical writers need to know - Volume 33, Issue

Clinical trial transparency is beneficial for patients, researchers, and the general public. However, rapidly evolving regulatory requirements for transparency have increased the information that will be published. Medical writers can play a key…

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…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

Medical Writing

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…

Pharmaceutical medical writing competencies: Comparing self-perception with employers' expectations - Volume 21, Issue

In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…

A stroll through the medical blogosphere - Volume 24, Issue

Medical blogs are a very popular way of communicating health-related information. They can be written by medical professionals or laypeople, and topics include diseases, procedures, health policies, and personal topics such as everyday experiences.…

Differences between writing for medical devices and pharmaceuticals: An update - Volume 31, Issue

Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…

A medical writing primer for oncology dossiers - Volume 31, Issue

Oncology is one of the most common areas of drug development in the pharmaceutical industry. As a medical writer, it is important to be aware of the unique aspects of oncology studies and have some understanding of the principles underlying cancer…

My First Medical Writing - Volume 31, Issue

I am pleased to share an article by an aspiring medical writer from Poland. Hanna KurlandaWitek finished her PhD in geoscience at the University of Edinburgh, specialising in microbiology. After working in an environmental consultancy for a few…

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…

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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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