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The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…
The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…
Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…
Human-centred “soft” skills are becoming increasingly essential, especially in the current digital workspace. As medical writers navigate the intricate landscape of compliance and precision, they must fortify their soft skills with a foundation of…
Despite calls for guidelines on reporting statistical aspects of studies, most journals have still not included in their instructions for authors more than a paragraph or two about reporting statistical methods and results. However, given that many…
Medical and other researchers in developing countries conduct much valuable research. Yet difficulties in writing and publication often prevent this research from being widely known. AuthorAID (http://www.authoraid.info), a project of the…
The articles included in this section are a selection from the EMA's news and press release archive for December – February 2015. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.
The articles included in this section are a selection from the EMA's news and press release archive for August–November 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu
The articles included in this section are a selection from the EMA's news and press release archive for March–June 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.
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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