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In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…
The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
For science to be understood, assimilated, and further developed, it must be accessible through clear and concise writing. Science is about solving problems that often interlink with each other. To improve the clarity of scientific writing, every…
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…
What’s up, doc? Defining a use for graphic medicine in veterinary communications Author: Louisa Marcombes This article aims to make the case for graphic medicine – comics in healthcare –and attempt to define their use in the veterinary field.…
I can't believe that my two years on the Executive Committee are now complete – what a journey from Manchester and Barcelona in 2013, Budapest and Florence in 2014, and finally Dublin in 2015. Apart from travelling many miles, I have had a great…
HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…
Data are economic assets that power the so-called fourth industrial revolution. The healthcare industry is at the forefront of this “data economy”. Medical writers should understand how to use these data appropriately and responsibly. This issue 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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