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Mentorship is often viewed as a traditional personal relationship model, where the mentor meets face-to-face with a mentee within the same organisation or group. However, I have been mentoring medical writers success fully for many years using…
Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…
In this post-truth era we live in, the validity of facts from climate change and evolution to the shape of the earth and even vaccine safety is challenged by misinformation. As scientists,we should make greater efforts to engage with the public and…
In this issue • We continue Michael Schneir's fascinating series on distractions in medical and scientific writing, this time concentrating on non-pronoun-induced backtracking with adverbs, verbs, and nouns. This sounds a little…
The placebo-by-proxy effect – another argument against homeopathy
Chances are you know about the placebo effect. There are many variables to study,1 but in general, the placebo effect means that if you believe in a positive outcome of a drug, you wi…
Must we choose between a path as a self-employed, freelance medical writer, or as an in-house employee? It might come as a surprise that a medical writer can enjoy both worlds. If you dream of becoming a freelance medical writer but dread losing…
For this special Sustainability issue of Medical Writing, the editorial team at Veterinary Medical Writing has decided to focus on One Health. As the global society adjusts to adopting a sustainable lifestyle, whether voluntarily or kicking and…
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 surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…
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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