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Yellowlees Douglas is a con sult - ant on writing and organisations and an associate professor in the Center for Management Com - munication at the University of Florida, USA. Maria B Grant is a professor of ophthalmology at the University of…
Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
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…
Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…
Building knowledge and capacity for patients and their advocates about the “systems” of healthcare is empowering for patients. The European Patients’ Academy (EUPATI) was established across Europe in 2012 to provide education and training to…
Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…
Dear MEW reader Welcome to the first 2012 Medical Writing or MEW issue – another EMWA milestone to start off this stellar year. I hope you enjoy the new design and the thematic focus on oncology. The theme of EMWA's upcoming 34th Spring conference…
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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