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Regulatory Writing - Volume 22, Issue

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 - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Regulatory Matters - Volume 30, Issue

The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…

Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance - Volume 24, Issue

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…

Regulatory Public Disclosure - Volume 30, Issue

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…

Leveraging infographics in study schemas - Volume 29, Issue

Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries - Volume 29, Issue

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

A first-timer's perspective on the 2013 EMWA conference in Barcelona - Volume 23, Issue

This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

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Scope

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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