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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…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…
The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…
Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…
Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…
New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…
Increasing amounts of information are being made available to patients – but how do we know if we are getting it right and meeting people's needs? In this article, we describe how we have employed user testing to test and improve not just…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Human-centred “soft” skills are becoming increasingly essential, especially in the current digital workspace. As medical writers navigate the intricate landscape of compliance and precision, they must fortify their soft skills with a foundation 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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