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The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…
Mentorship is a topic very close to my heart. If it were not for the numerous mentors in both my academic and professional life, I would not be here today. The definition of mentorship is subjective and how a mentor operates is often up to those…
The EMWA SIGs allow EMWA and its members to contribute to important conversations around topics that we know will impact on our industry in the coming years. You may have colleagues interested in joining the EMWA SIGs to debate, and share best…
In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…
We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…
Authors and co-authors This issue of Medical Writing is about Authors and Authorship, a topic, which despite stringent rules and regulations is sensitive, culturally-dependent and often full of emotion. I guess that we could have endless…
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…
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…
This is an article about my returning back to India from Europe and transition from research career to a profession of medical writing. I was introduced to medical writing through European Medical Writers Association (EMWA) while I was in Europe.…
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 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 medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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