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May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…
All three articles in this Veterinary Medical Writing section were written when COVID-19 was not classified as a pandemic. Yet all three articles tie into the current narrative of regulation in veterinary medicine and the need for communication…
EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…
In recent years, the robustness and reproducibility of preclinical data have been a topic for discussion. Quality standards and good practices are often not well defined for different in vitro methods and in vivo models,and not harmonised amongst…
The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
One of the benefits of being an EMWA member is having access to the webinar programme. In 2018, we are providing a new webinar almost every month of the year either in live or recordedformats. Thanks to our wonderful speakers, this year we’ve had…
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…
Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…
The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…
Welcome to this special edition of Medical Writing focusing on medical devices. When I volunteered to act as the guest editor for this issue, I did so knowing that we are at a crossroads in Europe. The Medical Device Directive is about to be…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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AI/Automation
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EMWA News
Gained in Translation
Getting Your Foot in the Door
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In the Bookstores
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My First Medical Writing
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
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Chris Monk