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The Transatlantic Trade and Investment Partnership (TTIP) has attracted increasing controversy, particularly in Europe. The TTIP is a trade agreement under negotiation between the United States and the European Union, and affects three main areas:…
A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation
Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…
Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…
Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common childhood disorders. First described in 1798 by Alexander Crichton, ADHD became widely known outside the medical profession with the publication of the story of Fidgety Phil…
Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
Statistical Thinking for Non-Statisticians in Drug Regulation (Second Edition) By John Wiley & Sons, 2014. ISBN: 978-1-118-47094-7 (hardcover).59.99 GBP. 368 pages. Writing for Science Journals: Tips, Tricks, and a Learning Plan By Geoff…
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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