Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and  relatively unknown regulatory document,  submitted as part of the redacted package of  a marketing authorisation application under  the EMA Policy 0070. The report documents  the methodology of…

Anonymisation: A new challenge for medical writers - Volume 27, Issue

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

Key factors a pharmaceutical company should consider while outsourcing medical writing services - Volume 23, Issue

Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…

An interview with Research Policy and Initiatives Director Roseline Favresse at the European Organisation for Rare Diseases - Volume 34, Issue

Roseline Favresse is the Research Policy and Initiatives Director at the European Organisation for Rare Diseases (EURORDIS). We interviewed Roseline to learn more about the rare disease landscape within Europe and the exciting recent collaborations…

Digital Communication - Volume 30, Issue

Digital communication – bringing us closer Digital or online communication is second nature to us all – with more than half of the global population active on the internet, a world without it seems unimaginable. In recent years, digital…

From editors abroad into businesswomen back in Brazil - Volume 22, Issue

After living for 12 years in the United States, and a career shift from bench scientist in molecular biology to science writer and editor, the author goes back home to Rio de Janeiro, Brazil, to found Publicase, a science communication company…

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…

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout

Exploring the role of Microsoft’s Copilot in visual communication: Current use and considerations through science communicators’ lens

Author: Jacqueline Bersano

Medical Writing. 2024;33(3):79–88. https://do…

Medical Communication - Volume 22, Issue

Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…