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Authors and co-authors This issue of Medical Writing is about Authors and Authorship, a topic, which despite stringent rules and regulations is sensitive, culturally-dependent and often full of emotion. I guess that we could have endless…
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…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…
Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles…
More and more clinical studies are taking place in Russia, making it an attractive market for medical writing. In 2011, the Ministry of Healthcare of the Russian Federation approved over 550 new clinical studies of all types, a 16% increase over the…
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…
Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in…
This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…
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…
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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