A shot at demystifying the risk management plan for medical writers - Volume 24, Issue

A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…

55th EMWA Conference - Volume 32, Issue

The 55th EMWA Conference took place on May 9–13, 2023, in Prague. With more than 400 participants from across Europe and the world, it was a rousing success. Topics of workshops and presentations ranged from the latest in regulatory writing and…

Medical writing in India at a crossroads - Volume 22, Issue

Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…

How mentorship has created a special community and helped people develop their careers - Volume 30, Issue

Mentorship is an extremely rewarding relationship between two people with the goal of professional and personal development. Elemed’s Mentoring Academy in partnership with the Regulatory Affairs Professional Society (RAPS) combines three pillars –…

Passing the Torch: The Sequel/Filling Big Shoes - Volume 29, Issue

For the last 8 years, I have been serving as Editor-in-Chief of Medical Writing. I feel that it’s time to pass the torch to a new person with new energy and fresh ideas. As I wrote in 2012, “This is yet another step in the evolution of the…

Five “translation” strategies to adapt technical content for lay audiences - Volume 33, Issue

Writing for lay audiences requires language that is understandable by readers without expertise in the subject matter at hand. This means carefully selecting, organising, wording, and supporting content, focusing on conveying relevant points in a…

Medical Writing in Portuguese: English to Portuguese translation: Know your audience! - Volume 33, Issue

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

Innovative use of master protocols for pivotal studies in rare diseases - Volume 34, Issue

Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…

RCTs: Can the treatment work? Patient registries: Does the treatment work? - Volume 26, Issue

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…