Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

Regulatory Public Disclosure - Volume 30, Issue

Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

Clinical trial transparency and disclosure from the medical writing perspective - Volume 33, Issue

It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restar…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

EMWA news - Volume 21, Issue

News from the EMWA Website Manager   New role At the recent EMWA conference held in Cyprus, I assumed the position of EMWA Website Manager. While this is a daunting task, it is a challenge I am pleased to take on. To ensure that I was in a…

Medical Writing

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of…

Comics aren't just for kids: Using cartoons in medical communications - Volume 30, Issue

Comics aren’t just for kids. They’re a provo - cative, entertaining, and storytelling medium powerful enough to captivate people of all ages, all languages, and all cultures – no small feat in today’s era of instant gratification. To engage our…

The Crofter: Sustainable Communications - Volume 30, Issue

Greetings from the croft! I think it’s a neat coincidence that I have the pleasure to write my first editorial to this edition of The Crofter in the Medical Writing special issue on mentorship. I don’t have an official mentor but ever since I…

Ama Appiah