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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…
Syntactic punctuation distraction Comma over-usage probably results from a tendency to pause and emphasise. How ever, such intuitive punctuation is counterproductive to the coordination of sentence core constituents, the intent of which is to cohere…
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…
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…
The use of artificial intelligence (AI) writing assistants in the healthcare industry is becoming increasingly prevalent. These tools can help medical writers to generate content more quickly and efficiently, but they also raise concerns about the…
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…
Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…
How does a team of medical writers working in different countries navigate different time zones and cultures to get their work done remotely? In this interview, a team of six medical writers and one editor working at P95, a private research…
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…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
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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