Your search for "clinical writing" matched 234 page(s).
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As patients are increasingly involved in healthcare decisions, there is a growing need for them to have access to appropriate health information. Medical writers, being a link between medical research and published data, are well placed to make…
The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…
The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
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…
This article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the…
In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…
Publishing Your Medical Research (Second Edition)Daniel W. ByrneWolters Kluwer, 2017Daniel Byrne has taught courses on biostatistics and medical writing at Vanderbilt University since 1999. He wrote the first edition of Publishing Your Medical…
Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…
EMWA team responds to ICMJE requirements on sharing clinical trial data In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…
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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