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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…
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…
A document template is defined as ‘a file that serves as a starting point for a new document’. This article looks at the specialised templates used by medical writers in their trade with a focus on the commercially available products. Templates…
Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…
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,…
This issue of Medical Writing focuses on authors and authorship, but where, in fact, did the term “authorship” come from? The term first appeared in the early 18th century. In a paper presented at the Annual Meeting of the National Council of…
As patients are increasingly involved in healthcare decisions, there is a growing need for them to have access to appropriate health information. Medical writers, being a link between medical research and published data, are well placed to make…
Since January 2015, EMWA has held a number of webinars on different topics. The most recent EMWA webinar was presented by Helen Baldwin on 25 June 2015 and was entitled ‘What you always wanted to know about medical writing - but never dared to ask’.…
October 5, 2018 and November 16, 2018 – Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Grampositive classes. EMA’s Pharmacovigilance Risk Assessment Committee…
At the 2023 EMWA Spring Conference in Prague, Czech Republic, EMWA hosted a poster session. There were posters related to many aspects of medical writing or of relevance to medical writers. The poster session presented an excellent way for…
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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