Plain language and readability - Volume 24, Issue

Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…

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.

Medical Writing in Chinese: Language-specific considerations for Chinese regulatory medical writers - Volume 33, Issue

Living medicine: The story of CAR T cell therapy - Volume 32, Issue

The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the…

Manuscript Writing - Volume 21, Issue

What are the most common reasons for a manuscript to be rejected (and how can they be avoided)? In their article on handling manuscript rejection, Woolley and Barron1 offer the following soothing advice: Authors, particularly inexperienced…

Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO - Volume 25, Issue

The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

Writing biosimilar clinical study reports and submission documents – what to expect and what to consider - Volume 28, Issue

With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity areincreasingly publicly available, it…