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The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
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…
Medical communication publications are designed to raise awareness of medicines, cosmetics, and technology. These publications ensure that doctors are informed about the role of new and existing medicines and the literature concerning appropriate…
Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…
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…
The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…
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…
In this edition of GYFD, we are happy to present to you two great contributions. Danae Rokanas shares with us some interesting statistics and important lessons learned from the first Live Internship Forum (IF) inMunich. In the second piece, St…
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…
The medical profession has a well-deserved reputation for atrocious handwriting, which has undoubtedly led to many mishaps in patient care. Sometimes, however, problems in interpreting doctor's writing, as those of us who have worked on publications…
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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