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More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…
Regulatory documents are prepared in a highly collaborative process within tight timelines. The time and the resources required for collecting input, organising document review, and processing the reviewers’ responses often dwarf those invested in…
The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…
Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…
Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…
Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…
New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…
Journal Policies Editorial policies and peer review process All feature articles submitted to Medical Writing are reviewed by a member of the Editorial Board. All Editorial Board members are experts in the field of medical writing and members…
Dear Members I am sure you are all very familiar with this situation – sitting in front of a blank piece of paper (or to be more accurate a blank screen) and wondering where to start. Beginnings and endings always seem to be the trickiest part, but…
A successful medical writer needs to be an excellent time manager, communicator, and team player, and show great attention to detail and commercial awareness, in addition to possessing core writing skills and the ability to evaluate and…
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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