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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…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…
Abstract Science journalism is undergoing a major transition due to changes in the relationship between science and society and dissemin - ation via digital and connective technologies, as is the case with other branches of journalism. The changes…
The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…
The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…
PETHEMA (Programa Español de Tratamientos en Hematología, or, Spanish Program for Treatments in Haematology) a leading cooperative group in haematological research, has increasingly integrated real-world data (RWD) as a complement to traditional…
The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…
Emotional intelligence (EI), the ability to recognise and understand emotions (one’s own and those of other people), is a valuable attribute for medical writers (MWs). MWs play a pivotal role in communicating medical and scientific information to…
Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…
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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