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Successive waves of COVID-19 have altered opinions and working practices. We conducted a survey in early 2020 among 759 members of the medical communications community, recruited via our network, seeking their experiences, opinions, and insights.…
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…
Excessive post-noun modification, usually as adjectival prepositional phrases, occurs fre - quently in research writing. Occurring less frequently, and less distracting, is excessive prenoun adjectival modification (i.e., stacked modifi cation). The…
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…
The misagreement in number (singular vs. plural) between subject and verb is caused by subject number ambiguity, either intrinsic (the subject itself) or extrinsic (the effect of subject modification).
Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…
An Introduction to Systematic Reviews by David Gough, Sandy Oliver, and James Thomas; SAGE Publications Ltd, 2013. ISBN: 978-1-849-20181-0. 26.99 GBP. 304 pages.
The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…
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…
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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