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Nearly everyone remembers the childhood tale of The Wizard of Oz. Four characters searched for something they believed magic alone could create, only to find that they already possessed it. The image of the Tin Man comes to mind, who believed he did…
November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency…
Master trial documents for increased efficiency and scientific integrity.
Brexit and the European Medicines Agency The British government has formally triggered Article 50, setting in motion Brexit and negotiations can begin in earnest. If before, politicians could gloss over the complexities, they are now obliged to…
Calling all medical writers:
Focus your writing with lean authoring
In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…
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…
One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…
Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…
Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…
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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