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Paragraphs are meant to make a text understandable and readable, and to help tell the story. Key aspects of good paragraphs include using topic sentences and story structures. Starting with an outline or a planand using it to build to topic…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…
Dear EMWA Members, When we surged en masse onto the dance floor at the Dublin Conference Spring Dinner, supercool ceilidh band ‘Perfect Friction’ were astonished, wondering ‘…what are these medical writers all about?’ We certainly breathed life…
The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…
Effective learning and development tools are important in spreading and consolidating knowledge within any pharmaceutical or biotechnology company. Medical communications professionals may be involved in creating training materials for many…
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…
Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. 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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