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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…
This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…
Section Editors: Zuo Yen Lee, Clare Chang I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document Author: Tiago Silva Medical writing is not easy, especially for new writers still learning the ropes.…
Crofting is a sustainable way of living It is cold and grey, and the wind is strong this morning, carrying a dash of rain. The crofter wakes up early. There is a sick sheep in need of care. A cow should give birth at any moment. There is a storm…
This section offers a selection from recent news items from the EMA. Medical Writing. 2023;32(2)86–91.
Thousands of clinical trials are conducted globally each year. Yet, little is known about their environmental impact. This paper presents the results of a high-level literature review of the carbon footprint of clinical trials. Five papers were…
Respected for their knowledge of animal health and disease, veterinarians safeguard animal health and welfare and, where applicable, the productivity of animals under their care. With the threats posed by climate change, the veterinary profession…
This article explores the major challenges and strategies for succeeding as a freelance medical writer. It covers several topics, including finding enough work, managing heavy workloads, ensuring document quality, and carving out time for…
Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…
A goal for all diseases is a treatment that works to prevent, halt, or reverse their effects – essentially, a cure. Achieving this requires early diagnosis, knowledge of disease mechanisms, and effective treatment. For rare diseases, each of these…
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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