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A symbiotic relationship is an “intimate interaction between two or more species, which may or may not be beneficial to either”.1We can think of the bee and flower relationship. The flower provides the bee with nectar, while the bee provides…
When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…
Activities around clinical documents disclosure have been slow since September 2018 when I last published this section. As many of you receive emails from the CORE Reference website (sign up at https://www.core-reference.org/subscribe), you have…
EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to…
Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…
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…
Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
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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