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Using an outline to organize your writing project can help keep you on a straight path and avoid wandering into wastelands of irrelevance. There are various formats – the classic hierarchal model, the IMRAD system used for research reports, the…
It is with great pleasure that I write my first editorial for this amazing issue on social media. The idea of this issue came to me in 2019, inspired by two special colleagues.
I had social media accounts even before I became a medical writer. I rec…
Abstract Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data…
A useful reference for writing pharmacovigilance documents Like other areas of medical writing, pharmacovigilance (PV) medical writing has many detailed regulations, guidance documents, and templates associated with it. As such, there is a…
Activities around clinical documents disclosure have been slow since September 2018 when I last published this section. As many of you receive emails from the CORE Reference website (sign up at https://www.core-reference.org/subscribe), you have…
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…
HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…
Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…
It is widely acknowledged that resolutions of difficulties tend to engender new problems. Increasingly, complex systems perpetuate increasing complexity. This discursive essay suggests that the most promising of discoveries, innovations, and…
Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…
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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