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Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…
Over the centuries people have become taller, heavier, and stronger. One of the major reasons for this is the increasing supply of calories in our diets. In earlier times, weight gain was extremely beneficial for health, well-being, and lifespan,…
With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity areincreasingly publicly available, it…
If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…
Dear Members I am sure you are all very familiar with this situation – sitting in front of a blank piece of paper (or to be more accurate a blank screen) and wondering where to start. Beginnings and endings always seem to be the trickiest part, but…
AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
More and more clinical studies are taking place in Russia, making it an attractive market for medical writing. In 2011, the Ministry of Healthcare of the Russian Federation approved over 550 new clinical studies of all types, a 16% increase over the…
The global use of social media has changed access to health information, and the internet has become its primary source for the general public. However, judging health information on social networks remains difficult for nonmedical readers since…
Search engine optimisation (SEO) is the process of optimising your writing so that it can be found easily on the internet. There are five key steps that you can take to increase the discoverability of your work, which will be discussed below. These a…
Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…
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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