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Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…
Section Editor: Kimi Uegaki Breaking barriers in sustainable development in East Africa: How Lightup Impact is leveraging communications to shift the power to the right actors Authors: Nicole Bezuidenhout, Valeria Santoro, Jeniffer Muganda …
Emotional intelligence (EI), the ability to recognise and understand emotions (one’s own and those of other people), is a valuable attribute for medical writers (MWs). MWs play a pivotal role in communicating medical and scientific information to…
Leading a team is inherently complex, requiring managers to juggle diverse organisational goals, meet superiors’ expectations, and cater to individual team member needs. The challenge intensifies when leading creative teams in a scientific environmen…
Pharma-Brexit is on its way. The announcement of the European Medicine Agency’s move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions…
We often write articles to satisfy two states of mind: pleasure and curiosity. In my case, this means the curiosity to delve into some of the intricacies of translation on the one hand, and, on the other, the desire to work together with colleagues…
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…
The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…
Conditional marketing authorisations give patients access to important new medicines earlier January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union…
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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