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In the world of regulatory public disclosure (RPD) things rarely stay the same for long. This regular RPD section in Medical Writing and EMWA’s RPD SIG help you keep up.
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…
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…
The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
In recent years, regulators across the globe have improved the way they communicate to patients and the general public about their activities and how medicines are regulated.
Quality assurance (QA) is an important part of the translation process; its ultimate aim is to ensure that a high-quality translation is produced. Traditionally, QA was very much a task undertaken by humans, but recent years have seen the advent of…
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…
The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…
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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