Revision: Parameters and practices within the translation industry - Volume 27, Issue

In this article we look at what it means to revise a translation, the parameters that should be taken into account, and the various challenges posed by the process. We also explore how the quality of a translation affects the revision stage, and…

Medical translation: A driving force behind equitable access to healthcare - Volume 33, Issue

In this Medical Writing issue on Translation, we explore the transformative role of translation in advancing medical communications and improving access to healthcare. Translation is the intricate process of converting the written word from one…

Regulatory Public Disclosure - Volume 32, Issue

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

Real-world data and evidence: A European regulatory perspective - Volume 34, Issue

The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…

The Regulatory Public Disclosure Special Interest Group - Volume 27, Issue

Who are we and what do we do ? The Regulatory Public Disclosure Special Interest Group (RPD SIG) was first conceived in December 2015 and is a group of EMWA members supporting other EMWA members. The RPD SIG objective is: “to provide a forumfor the…

Profile: An interview with Dr Gustavo A. Silva on the concept of public health in medical writing and translation - Volume 22, Issue

We often tend to consider the different branches of medical translation as unique islands of knowledge. We may imagine translators specialising in single areas such as oncology, ophthalmology, gynaecology, and so on. Nevertheless, there are indeed…

The evolution of biotechnology: From ancient civilisations to modern day - Volume 32, Issue

This article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

In the Bookstores - Volume 22, Issue

The Spirit Level

Ever had a ‘ping’ moment? This book might have been mine. I'm not a natural pessimist, but Western society today seems less cohesive and people more materialistic, stressed, unhealthy, and unhappy than in times gone by. Wealth and s…

The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective - Volume 32, Issue

Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…