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This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…
See you in Valencia… Time is flying. We just left the autumn conference and now are approaching our main EMWA event – the spring conference, to take place May 7– 11, 2024. This time we go to Valencia, and I am sure that no one needs to be…
We hope that everybody is safe and well – as far as this is possible in the current scenario. COVID-19 is affecting every part of our lives, but we will try our best to help you through these times. Even though the Spring Conference in Prague had to…
A good mentor may be a good line manager in a business setting and vice versa, but there are some key differences: mentors are more skill-oriented, while line managers are more goal-oriented. People who are both good line managers and mentors are…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
The use of vaccines and immunotherapies in medicine dates back to the end of the 18th century and the work of Edward Jenner, the father of immunology. Jenner, building on the observations of John Fewster in 1768, showed that inoculation with the…
April 12, 2018 – The European Medicines Agency's (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as…
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…
Comics aren’t just for kids. They’re a provo - cative, entertaining, and storytelling medium powerful enough to captivate people of all ages, all languages, and all cultures – no small feat in today’s era of instant gratification. To engage our…
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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