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On multilingualism and medical writing I arrived in Europe in September 1991 and was completely unprepared for the multilingualism of this continent. My first European home was the bilingual city of Brussels in the trilingual country of Belgium.…
Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…
Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…
This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
Medical researchers in Middle Eastern countries have been forced to confront the fact that scientific publication has become the cornerstone of knowledge dissemination and academic promotion. Regional initiatives, such as the foundation of the…
The August 2013 issue of European Science Editing (ESE), the journal of the European Association of Science Editors, included a couple of articles relating to the San Francisco Declaration on Research Assessment, on which I comment elsewhere in this…
With the growth of information technology over the past decade, digital identifiers have been introduced for the unique and stable identification of digital objects in cyberspace. Digital identifiers have applications in many contexts, including…
Preclinical studies –is animal testing necessary?The drug regulatory authorities require testing in animals, to be exact in at least two mammalian species, before the first-in-human trials can be approved. Common criticism is that the results from…
Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…
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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