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Medical Devices - Volume 28, Issue

Medical devices should certainly be included on any list of trends in medical writing. That impression was only reinforced by the strong interest in device writing evident at this year’s EMWA spring conference. The three medical device workshops on…

The Crofter: Sustainable Communications - Volume 30, Issue

Greetings from the croft! I think it’s a neat coincidence that I have the pleasure to write my first editorial to this edition of The Crofter in the Medical Writing special issue on mentorship. I don’t have an official mentor but ever since I…

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…

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

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…

From academia to freelance medical writing: Navigating the transition - Volume 32, Issue

Academics who have transitioned to medical communications (MedComms) find that there are many parallels between the two fields, leading to fulfilling and rewarding careers. Many of the skills honed in academia such as research, technical writing,…

The freelance medical writer and the medical writing agency: A symbiotic relationship - Volume 32, Issue

The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…

Five questions for Ruggero Galici on nonclinical medical writing - Volume 32, Issue

Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…

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…

Harmonising linguistic validation with AI: Precision, efficiency, and the human touch in patient-reported outcome translation - Volume 33, Issue

The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…

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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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