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How to soften the red pen’s blow: Tips for editing a colleague’s work - Volume 27, Issue

Applying the dreaded red editing pen to colleague's work can be nerve-racking for professional writers. But there are some concrete steps every writer can take that will improve his or her ability to communicate the type of clear, constructive…

The role of real-world evidence in post-market clinical follow-up - Volume 34, Issue

Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements, methodologies, and…

From researcher in Europe to medical writer in India - Volume 21, Issue

This is an article about my returning back to India from Europe and transition from research career to a profession of medical writing. I was introduced to medical writing through European Medical Writers Association (EMWA) while I was in Europe.…

From algorithms to insights: The role of medical writers in AI-enhanced real-world evidence - Volume 34, Issue

Real-world evidence (RWE) complements randomised controlled trials (RCTs) by assessing treatment effectiveness in diverse populations. Integrating artificial intelligence (AI) and machine learning (ML) enhances RWE by enabling predictive modelling,…

Protecting the rights of clinical trial patients through disclosure: The significance of plain language - Volume 27, Issue

Taking a step back to understand the history of clinical trial regulation triggers a broader perspective on the work we do or the work we will do. As regulatory medical writers, our role is often limited to the more technicalsubmission-level…

RCTs: Can the treatment work? Patient registries: Does the treatment work? - Volume 26, Issue

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…

Good regulatory practice and the role(s) of a regulatory affairs professional - Volume 22, Issue

Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles…

Training and development opportunities for medical writers from different regions across the world - Volume 33, Issue

In the dynamic and rapidly evolving field of medical writing, continuous learning and professional development are crucial for success. Medical writers play a vital role in translating complex scientific and medical information into clear, accurate,…

News and Notes from the World of Medical Writing - Volume 30, Issue

EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…

EMWA News - Volume 25, Issue

Baby alarm in the Social Media Team! The future of EMWA’s social media team is secured as we are expecting three babies. Utmost efforts have been taken to ensure they are equally distributed across the Twitter, Facebook and LinkedIn teams.Seriously,…

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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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