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Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
Whoever writes wants to be read. Yet, even if we succeed in creating an informative, logically structured, and adequately worded text tailored to our target audience, i.e., text we consider to have an adequate level of readability, our documents may…
Learner-centred teaching is particularly suited to the teaching of scientific writing. The underlying premise of the learner-centred approach is simple: the learner will better assimilate new information if it is built on what they already ‘know’…
Welcome to my second Gained in Translation editorial! Translation consulting networks are an interesting ‘assisted-translation tool’, which have had a remarkable appeal for professionals in the field since the late 1990s. Newsgroups, online…
The placebo-by-proxy effect – another argument against homeopathy
Chances are you know about the placebo effect. There are many variables to study,1 but in general, the placebo effect means that if you believe in a positive outcome of a drug, you wi…
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…
In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…
Who are we and what do we do ? The Regulatory Public Disclosure Special Interest Group (RPD SIG) was first conceived in December 2015 and is a group of EMWA members supporting other EMWA members. The RPD SIG objective is: “to provide a forumfor 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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