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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…
Patient education that overcomes literacy barriers supports quality care. This article provides an overview of health literacy, describes the concepts of readability and accessibility, and discusses how to empathise with the patient's experience and…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
Zotero is a free, open-source reference management program compatible with Linux®, Mac®, and Windows® operating systems. Libraries are backed up online allowing sharing between computers and even multiple users. Zotero makes it easy to keep your…
Medical writers’ texts are either written for specialists or for non-professionals such as patients and their relatives. Medical writers whose work is intended for patients cannot merely impart facts. They also need to demonstrate that they…
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…
Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was…
In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…
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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