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Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…
This article provides a list of software useful to medical writers according to the booklet ‘The WRITE tool for the job’ compiled by Emma Hitt. Software categories include: word processors; reference managers; PDF readers; project planning and…
Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…
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…
In the first quarter of 2022, Bioforum performed an anonymous internal survey among its medical writers to understand if our employees would like to return to a physical office or prefer to stay in the home office despite the lifting of most of the…
A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.
Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…
A wintry London in January saw the release of the first joint position statement on the role ofthe professional medical writer (page 7). But why do we need such a statement and what does it say? The Executive Committee identified the need to update…
Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over…
Remote working is ideal for medical writers, but up until a few years ago, was not widely available to those looking for a remote position with a German employer. Even though Germany is a developed country, its digitalisation has long been lagging,…
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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