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An interview with Cathal Gallagher of EMA’s Technical Anonymisation Group - Volume 29, Issue

In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…

Profile: An interview with Fernando Navarro on the brand new platform ‘Cosnautas’ - Volume 23, Issue

Some people may still not be aware of the big news last summer in the Spanish medical translation and writing world: Fernando Navarro's Libro Rojo (translated as ‘Red Book’, one of the most authoritative English to Spanish dictionaries of medicine)…

Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy - Volume 23, Issue

Clinical research coordinators (CRCs) – a CRC is not a clinical research associate but one is frequently mistaken for the other – have a fundamental role in clinical research. Their work involves a wide range of activities and responsibilities in…

Profile: An interview with Karina Ruth Tabacinic on some fundamental concerns of medical translation - Volume 23, Issue

Medical translation has had a fundamental role in the history of scientific knowledge – ancient, past, and modern. It involves a larger array of working parts than is commonly brought to bear upon the study of other semantic activities. It calls…

Profile: An Interview with Michael Markie - an open science and open data advocate - Volume 26, Issue

Medical writers commonly are hired to write for traditional journals targeting the highest possible impact factor. However, as medical writers, we should be aware of alternative options. In September last year, I had the pleasure to meet Michael…

Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance - Volume 24, Issue

To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…

Editorial - Volume 27, Issue

A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.

In the Bookstores - Volume 21, Issue

A personal view incorporating the insights of a UK-based book group Henrietta Lacks was a 31-year-old African American who died in 1951 from cervical cancer. Her biopsied cancer cells were taken without her permission, propagated seemingly forever…

Digital Communication - Volume 32, Issue

Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…

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)…

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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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