Localisation of promotional materials for pharma - Volume 33, Issue

Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…

An introduction to little-known aspects of nonclinical regulatory writing - Volume 26, Issue

Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

Medical Devices - Volume 30, Issue

Hello, medical device fans! Social media is increasingly integrated into all aspects of our daily lives, even for many of you non-digital natives (myself included). In this issue, we look at how the medical device industry is beginning to utilise…

In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

The Light Stuff - Volume 22, Issue

Decoding the Japanese Code 1: Yes means yes, and no does not exist At a recent dinner, my husband and I were chatting with a university professor, a Japanese fellow who has lived and worked in Europe and the US. We talked about cross-cultural…

Post-approval regulatory writing - Volume 23, Issue

Special section: Winners of the Geoff Hall Scholarship essay competition - Volume 24, Issue

The Geoff Hall Scholarships (GHSs) are given in honour of a former President of EMWA. Geoff was a very special person, an extremely valued member of EMWA, and a very good friend to many EMWA members. He firmly believed that the future of EMWA lies in…

In the Bookstores - Volume 26, Issue

A research paper is often the culmination of years’ worth of data and experiments, successes and failures, doubts and triumphs, as well as a balancing act between many different opinions from different authors. Writing one can be a daunting task,…

Veterinary Medical Writing - Volume 32, Issue

Abstract Human medicine has recently seen a move away from the paternalistic patient-physician paradigm course to a collaborative one, where “shared decision-making” is a core principle. No longer a passive bystander, where their case management is…