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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…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

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…

Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations - Volume 24, Issue

Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…

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)…

Editorial - Volume 33, Issue

Medical writing transcends borders, uniting professionals across geographies, demographics, languages, and cultures. This inherent global perspective has inspired the theme for this issue. While previous editions have explored medical writing in…

EMWA News - Volume 28, Issue

On July 29, EMWA, together with the American Medical Writers Association (AMWA) and the International Society for Medical Publication Professionals (ISMPP), issued a joint position statement on the dangers of predatory publishing (see p. 34 of this…

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…

Publications - Volume 33, Issue

ICMJE recommendations update: What’s new? Section Editor/Author: Maddy Dyer In January 2024, the International Committee of Medical Journal Editors (ICMJE) updated their “Recommendations for the Conduct, Reporting, Editing, and Publication of…

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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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