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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…

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…

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…

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

The medical writing landscape in China - Volume 28, Issue

The Chinese medical regulatory writing and medical science writing landscapes are chang - ing rapidly. Changes in regulatory reforms continue as China further strives to align its pharmaceutical industry with the world, which necessitates…

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…

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…

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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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