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Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…
Welcome to the first issue of medical writing in 2015 on plain language, which means that this message had better be simple and easy to read. I am a huge advocate of plain writing and, as a Publication Manager, spend much of my time working with…
Section Editor: Adriana Rocha Navigating my freelance journey while driving EMWA freelance activities Author: Laura A. Kehoe I didn’t plan to become a medical writer, but then again who does? It wasn’t, at the time, a career on the list of things…
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
Dense, hard-to-follow writing obfuscates complex subject matter, but writers can improve their ability to communicate complex topics with clear writing that is easily understood on a first read. Science and medical writing often contain grammatical…
Ethical and evidence-based medical communications are gaining increasing importance in emerging pharmaceutical markets, outside of North America and Western Europe. In large pharmaceutical companies resources are limited, and small and mid-sized…
Section Editors: Louisa Ludwig-Begall, Sarah Kabani Saving the planet, one EMWA conference at a time Author: Adam Jacobs I had been a frequent business traveller for some years until not so long ago. Most of my trips were by plane. I would…
The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…
There are different definitions of the adjective ‘good’, e.g. morally excellent; satisfactory in quality, quantity or degree; of high quality; excellent; well-behaved; etc. as the web dictionary tells us. In ‘good pharma’ the meaning of ‘good’ is…
Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…
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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