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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…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee Briefing documents: Facilitating health authority interactions Author: Clare Chang Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…

Regulatory Matters - Volume 33, Issue

Section Editors: Clare Chang, Zuo Yen Lee Navigating the regulatory landscape of gene therapy Medical Writing. 2024;33(4):89–93. https://doi.org/10.56012/wjxo2860

Regulatory Matters - Volume 32, Issue

Section Editors: Zuo Yen Lee, Clare Chang I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document Author: Tiago Silva Medical writing is not easy, especially for new writers still learning the ropes.…

Regulatory Matters - Volume 31, Issue

Contributors: Ri Xu (author) Zuo Yen Lee (section editor), Clare Chang (section editor) Hand and back muscle pain and how to avoid them: A regulatory writer's story Ri Xu Medical Writing. 2022;31(3)68-71. https://doi.org/10.56012/thzz1704

Regulatory Matters - Volume 32, Issue

Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…

Editing for writers who have English as an additional language - Volume 27, Issue

Editors of English are typically met with expectations to make a quick fix of documents that need more radical changes than authors think. As editors, we should convey how we work to improve readability, and either adjustor gain acceptance for our…

Getting Your Foot in the Door - Volume 27, Issue

GYFD congratulates the EMWA Internship Forum team for another great event in Barcelona. Also in this edition, first time attendee Clare Chang shares with us some insights she gained in herquest for getting that first medical writing job. I am sure…

Regulatory Matters - Volume 33, Issue

Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

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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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