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In an age of increasing digitisation, pharmaceutical product information is evolving. This transformation reflects growing recognition among regulators of the value of patient engagement and widespread societal calls for increased transparency of…
Many medical writers and translators are not members of professional associations. While online networking is clearly accepted as a key element for success in business, the benefits of joining associations are still not obvious to all, even though…
Mentorship is a topic very close to my heart. If it were not for the numerous mentors in both my academic and professional life, I would not be here today. The definition of mentorship is subjective and how a mentor operates is often up to those…
Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…
Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…
The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…
The 45th EMWA Conference in Cascais, Portugal, has recently finished and we are all waiting for the upcoming annual event in Barcelona, Spain, next Spring. In the meantime, the Executive Committee is working hard on improving what EMWA has to offer…
Writing is something that I have always loved. Actually, as a teenager I would have studied literature, but I changed my mind at the last year at school. I became a paediatrician instead for a few years but then little by little, my career turned…
Medical communicators can choose words that influence how people perceive individuals and populations who take part in research. For many years, the term subjects was used ubiquitously and internationally in clinical research. However, this term can…
In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory…
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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