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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…
Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…
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…
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…
In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…
Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…
Unlike medical writing, ‘veterinary writing’ does not exist as a defined career path. However, writers are inevitably also required in this field and play important roles in different areas of the veterinary profession for creation of scientific…
The International AIDS Vaccine Initiative (IAVI) is a global scientific and advocacy organisation dedicated to ensuring an AIDS vaccine for use worldwide. In Africa, IAVI partners with seven research centres who conduct vaccine trials and studies.…
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…
In this issue of Medical Writing dedicated to regulatory writing, many of the articles provide some glimpses of the day-to-day problems and dilemmas faced by regulatory writers. It is hard, however, to describe the essence of regulatory writing in a…
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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