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Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…
The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…
On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…
Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…
In this edition of GYFD, we are happy to present to you two great contributions. Danae Rokanas shares with us some interesting statistics and important lessons learned from the first Live Internship Forum (IF) inMunich. In the second piece, St…
Ambassadors Programme News The EMWA Ambassadors Programme is continuing its efforts to reach out to new audiences to promote medical writing and EMWA. Marie Kołtowska-Häggström gave a talk (in Polish) on medical writing as a profession at the…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
Help, I can't shorten my abstract! Oh yes you can! (Part 1 of 2) Abstracts are perhaps the most important part of a manuscript because they are often the only part that is read and used as an information source. They are also used by readers…
What are the differences between medical journalism and medical writing? To find out, the authors reviewed several health-related publications and online resources, and interviewed two senior medical journalists. We learned that medical journalism…
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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