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A complete re-evaluation of your career path can be a daunting task. By identifying your own key skills, a proactive approach can be taken. Talking to varied companies and people in the field and trying out different writing styles can help to find…
The unique nature of patient-reported outcome (PRO) measures presents unique challenges for translation. Regulators emphasise the importance of maintaining conceptual equivalence across all languages in multilingualand multinational trials, while…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
Artificial Intelligence (AI) and machine learning-driven software are evolving toward a technological advancement revolutionising the current global, social, and economic landscape. A major breakthrough in AI is the fast-growing natural language…
Good Writing Practice Writing abstracts for congresses (2) Tables and Figures Unlike manuscript abstracts, congress abstracts may often include tables or figures, or both. Many congresses allow these to be submitted alongside the abstract text,…
Grammatical misagreement in tense
I – Present, present perfect
Introduction
Each of the sections of a journal article contains anticipated conceptual components, which can be expressed by a specific verb tense for the perspective of time and the d…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
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…
Issues in paediatrics Infants, children, and adolescents have special needs regarding their health and care. They are not ‘little adults’. The spectrum of illnesses differs from that known in adults. Just think of teething problems like…
The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
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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