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Landscaping the terminology of accessible language document types - Volume 31, Issue

There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

Advancing health equity through language access – a global imperative - Volume 33, Issue

In this article, the authors outline the universal right to health, healthcare, and language access in healthcare, with a focus on policies and practices in the European Union and the United States. The authors spotlight contrasting views on whether…

The past - the present - the future - Volume 31, Issue

Dear colleagues, friends, and EMWA members,Happy 30th EMWA anniversary!We have an exciting new year ahead of us. To celebrate EMWA’s 30th anniversary, we will take a deep dive into EMWA’s history, celebrate our present accomplishments, and aim to…

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…

The Lay Protocol Synopsis: Requirements and feasibility - Volume 32, Issue

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…

Veterinary sustainability - Volume 31, Issue

Respected for their knowledge of animal health and disease, veterinarians safeguard animal health and welfare and, where applicable, the productivity of animals under their care. With the threats posed by climate change, the veterinary profession…

Charting your way to the top: The 12 major milestones of freelance medical writing - Volume 32, Issue

As a freelance medical writer, it’s tough to know how well you’re doing – conventional career metrics don’t apply and you don’t have a boss keeping tabs on you. Yet, for your medical writing business to stand the test of time, with you at the helm,…

Bringing decentralised clinical trial protocols to life - Volume 32, Issue

Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components…

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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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