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Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
Many people do not take their medicines as prescribed, and medicines can cause harm if not used appropriately. In addition, in most health systems there is increasing discussion about involving patients in decisions about their health – including…
To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…
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…
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…
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…
Ethical and evidence-based medical communications are gaining increasing importance in emerging pharmaceutical markets, outside of North America and Western Europe. In large pharmaceutical companies resources are limited, and small and mid-sized…
A year of EMWA firsts has passed and while we are still not in a post-pandemic phase, one can see that our profession has regained its momentum. In the past, you might have experienced the need to explain to family members and friends what “medical…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
This article examines the clarity of several health information leaflets issued to the public in Europe. It finds that some of the language is quirky, ambiguous, and confusing. In one leaflet, the size of type is too small for easy reading, even by…
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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