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Patient education that overcomes literacy barriers supports quality care. This article provides an overview of health literacy, describes the concepts of readability and accessibility, and discusses how to empathise with the patient's experience and…
‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…
In contrast to controlled clinical trials, findings of preclinical studies are not available. The road from laboratory discovery to usable therapy is still long and windy. Many preclinical studies have not been replicated by the pharmaceutical…
The needs assessment component of a continuing medical education grant proposal document describes why a specific programme should be developed. Medical writers frequently play a central role in producing the needs assessment as an important first…
To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…
The major change in medical decision making over the last 50 years has been the realisation that treatment decisions would be improved if doctors’ existing knowledge was supplemented by evidence generated systematically through health services…
Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection 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 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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