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The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…
The current medical communication environment is characterised by growing calls for increased data transparency. There are ongoing concerns about the selective publication of trial results and the potential impact on use of medicines by prescribers…
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…
Although the importance both of skills in medical writing in English and of an understanding of ethics in medical publishing is increasingly recognised, these subjects are not comprehensively taught to Japanese medical doctors and students. Limited…
Medical communication publications are designed to raise awareness of medicines, cosmetics, and technology. These publications ensure that doctors are informed about the role of new and existing medicines and the literature concerning appropriate…
Datavision™ is a publication planning software tool that is widely used across the healthcare industry to manage publication programmes. Medical writers are one of the key Datavision user groups, and need to know how to use the elements of the…
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…
Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…
Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…
Altmetrics and other article-level metrics offer new opportunities to understand the impact of medical publications and, indeed, clinical trial programmes. For example, we can learn whether the publication has been viewed, shared, engaged with, or…
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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