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The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…
Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…
Insulin was first purified in 1921 by Frederick Grant Banting and Charles Herbert Best at the University of Toronto. Soon after, the benefits of using insulin to treat diabetes was discovered, the patent was sold to the University of Toronto for $1,…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
Exercise physiology has not always been held with the same regard as other scientific disciplines. Despite the often held view that it is confined to the study of sport, exercise physiology has contributed to some of the most important scientific…
Abstract Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data…
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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