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Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
In French, the grammatical rule of the generic masculine, known as neutral, reveals a patriarchal worldview. This article looks at the consequences of this way of writing in medical texts and in medical translation. It also gives suggestions on how…
Dense, hard-to-follow writing obfuscates complex subject matter, but writers can improve their ability to communicate complex topics with clear writing that is easily understood on a first read. Science and medical writing often contain grammatical…
Over her 40-year career, Kelley Hill has become regarded as an industry expert in strategic, high-quality, and impactful regulatory writing, especially in the rare disease space. Now enjoying a slower pace of life having retired in 2023, she has led…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
The move towards patient engagement and patient involvement in healthcare decisions (“shared care”) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with…
Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…
At the start of a medical writing career, the quality control (QC) step can fill writers with a sense of dread. Someone is holding a magnifying glass to your carefully crafted (and at this point deeply loved) document and is trying to pick holes in…
Meeting reports are an aspect of ‘medical’ and other technical writing that has had little discussion. The following might be of interest to medical writers asked to provide rapid, reliable, objective reports of various types of meeting. The United…
In this first issue of 2018, I’m delighted to introduce an excellent article from one of EMWA’s newest Workshop Leaders, John Dixon. Although John is new to teaching at EMWA, he’s extremely experienced in his field – or, more correctly, fields! John…
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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Alicia Brooks Waltman
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