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As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised…
Meeting reports are an aspect of ‘medical’ and other technical writing that has had little discussion. The following might be of interest to medical writers asked to provide rapid, reliable, objective reports of various types of meeting. The United…
The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…
Dear Medical Writers Top of Form Bottom of Form The last time I wrote to you I briefly introduced myself and outlined some of the plans that I hope to realise during my year as president. However, as president I am only one of the members of the…
Good medical writing is like good writing in any discipline: the writer should explain complex concepts and ideas clearly and accurately and engage the reader. In this article, I provide four suggestions to help clarify writing on complex subjects:…
A proposal to define a new category of bad practice – The non-publication of clinical trial results
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
Medical advisory board meetings are anintegral part of the healthcare and, inparticular, the pharmaceutical landscape.These meetings serve to identify knowledgegaps in a specific therapeutic area and tosuggest measures that could be implementedand…
The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
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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