Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee

The AI-enabled medical writer: A new era for regulatory writing

Authors: Jenni Pickett, Vanessa de Langsdorff

As artificial intelligence (AI) becomes increasingly integrated into the pharma ceutical indust…

Quality assurance in medical translation - Volume 33, Issue

Quality assurance (QA) is an important part of the translation process; its ultimate aim is to ensure that a high-quality translation is produced. Traditionally, QA was very much a task undertaken by humans, but recent years have seen the advent of…

Rush to publication – What do we have to lose? - Volume 29, Issue

Just as the research and development of new drugs requires careful, often painstaking, adherence to empirical processes, the peer-review process and, indeed, the manuscript preparation process, are likewise laborious and time-consuming. The benefits…

President’s Message - Volume 25, Issue

Dear EMWA Members, It is my very great pleasure to ‘speak’ to you from the pages of the very first issue of Medical Writing of 2016, with our new printer, Hastings. I am particularly excited that our feature articles are now open-access – a…

English Grammar and Style - Volume 21, Issue

Pleasing the reader The fundamental principle in the practice of medicine, ‘first, do no harm’, could be transposed to the world of medical writing to ‘first, do not annoy’. The Good Writing Practice (GWP) group at EMWA has been focussing on…

Guest Editorial: Medical writing and health economics/market access: A health economist's view - Volume 22, Issue

Having had the pleasure of attending the one-day symposium on health economics and market access at this year's Spring EMWA conference, and of teaching a workshop on health economics at the conference, two points struck me.

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…

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries - Volume 29, Issue

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…

Where have all the UK entry level pharmaceutical regulatory medical writing jobs gone? - Volume 25, Issue

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…