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I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
Building knowledge and capacity for patients and their advocates about the “systems” of healthcare is empowering for patients. The European Patients’ Academy (EUPATI) was established across Europe in 2012 to provide education and training to…
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…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…
The spring EMWA conference held in Barcelona is now behind us – and what a conference it was for medical device writers and those who want to become one! A full symposium day on medical devices with more than 200 registrants and two fully booked…
Making the first steps as a medical writer in the pharma and biotech industry can be challenging. Three general principles can help managers foster the growth and development of their team members: Reveal, Rebalance, and Release. Reveal means that…
Some more four-letter words I published a series of articles in The Write Stuff on short words frequently used in the medical and scientific context between Volume 16(3) 2007 and Volume 18(4) 2009. Since then, at training courses and in email…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
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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