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…

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…

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…

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…

Regulatory writing for rare disease: An interview with Kelley Hill - Volume 34, Issue

Over her 40-year career, Kelley Hill has become regarded as an industry expert in strategic, high-quality, and impactful regulatory writing, especially in the rare disease space. Now enjoying a slower pace of life having retired in 2023, she has led…

The changing face of (benefit-)risk management - Volume 24, Issue

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…

Clinical trial results disclosure on ClinicalTrials.gov and EudraCT - Volume 27, Issue

The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available…

Subcontracting: Not for the faint of heart - Volume 28, Issue

Subcontracting can be the answer to a successful freelancer’s prayers, or the opportunity to work harder than you have ever worked before for less money than you made when you were a struggling newbie. The potential advantages of subcontracting are…

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…