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Pleasing the reader The fundamental principle in the practice of medicine, ‘first, do no harm’, could be transposed to the world of medical writing to ‘first, do not annoy’. The Good Writing Practice (GWP) group at EMWA has been focussing on…
Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…
Data sharing is encouraged by institutions and journals: Authorship of “shared” papers should be clearWhen researchers share data, the teams analysing them want to publish their results. How should authorship of publications be defined? Who are the…
Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
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…
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…
Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…
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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Alicia Brooks Waltman
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