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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…

Regulatory Matters - Volume 29, Issue

Background for immunooncology studies - Accumulated research of more than a century has led to our current expansive understanding of the vertebrate immune system as a complex, multi-functional, evolutionary unit: a diverse, powerful, and adaptable…

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)…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

In the Bookstores - Volume 32, Issue

Medical writing books on a budget Allison McIntosh has collected several shelves of books on medical writing. In this article, she provides a selected list of books that can be purchased for less than £10 (approximately €10). Contributors: Alison…

Regulatory Matters - Volume 30, Issue

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

The Webscout - Volume 26, Issue

Medical devices range from things as simple as an injection needle to implantable pacemakers and MRI imaging devices. A video by the WHO (http://t1p.de/WHOVideo) gives you an impression of the variety of medical devices and their importance for…

English Grammar and Style: Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 3 - Double syntactic unit revision and syntactic position revision - Volume 24, Issue

This is the last of this series of three articles on pronouns that cause distraction by making the reader backtrack. In the first part of this article, we examine a technique for eliminating backtracking by making two changes to the construction of…

Good Writing Practice - Volume 26, Issue

Syntactic Structure - Inter-sentenceIncrementalism: SentencesInter-sentence incrementalism is an expansion of information, often secondary, into a sentence rather than a reduction of the information to a clause or phrase and incorporation (sentence…

My First Medical Writing - Volume 34, Issue

Section Editor: Evguenia Alechine Gut feeling and chronic pain: Revisiting the microbiota connection Author: Janaine Prata de Oliveira Medical Writing. 2025;34(3):128–130. https://doi.org/10.56012/bxad7017

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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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