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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…
The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…
With the advent of social media platforms and the increasing availability and access of information on the internet, we are not limited by information sources on any subject. Medium.com, since its inception in 2012, has become a very good blogging…
Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…
Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
With the advent of the pandemic, global businesses in medical writing accelerated efforts to hire remote professionals across different countries. Portugal is a fruitful source of talent, yet it remains under-represented in the medical writing…
EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…
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…
Crofting is a sustainable way of living It is cold and grey, and the wind is strong this morning, carrying a dash of rain. The crofter wakes up early. There is a sick sheep in need of care. A cow should give birth at any moment. There is a storm…
Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…
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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