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Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…
Uncertainty is an unavoidable problem when analysing health technology assessment results, which can make decision making difficult. Whilst we have ways of presenting uncertainty for individual outcomes in a systematic review, we do not have a…
The reach and impact of social media have made this communication channel the latest in a number of multidimensional communi - cation tools to be employed in health research. Social media has become a com - muni cation tool to reach various…
Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…
Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
The history of immunotherapy to treat cancer began in 1891 when the American surgeon William Coley performed intra-tumoural injections with inactivated bacteria in patients with advanced sarcoma, in an attempt to stimulate anti-tumour immunity.…
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…
Medical writers are increasingly likely to come across patient apps in their work, and we describe here the background and use of two apps for assessing patient-reported outcome (PRO). Systematic collection of PRO data via patient apps has been…
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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