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The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…
The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…
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…
Abstract Compliance with European regulatory standards in animal research could be viewed as a way of dotting the i’s and crossing the t’s, rather than actually holding the research to scientific scrutiny. Standardisation is important and needs…
The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) recognise the challenges to scientific publishing being posed by predatory…
Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…
The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available…
Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…
September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…
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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