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Since the first biosimilar product was approved in Europe in 2006, there have been many developments in the global regulatory environment, and the healthcare community’s understanding and acceptance of biosimilars. However, there are still a number…
Preclinical studies –is animal testing necessary?The drug regulatory authorities require testing in animals, to be exact in at least two mammalian species, before the first-in-human trials can be approved. Common criticism is that the results from…
The training of medical writers is not to be taken lightly and requires serious input from industry, established medical writers, and the academics making the transition. Following on from previous articles in Medical Writing, Sarah and Adrian Tilly…
Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that…
The use of vaccines and immunotherapies in medicine dates back to the end of the 18th century and the work of Edward Jenner, the father of immunology. Jenner, building on the observations of John Fewster in 1768, showed that inoculation with the…
In this article, I provide a checklist of eight items to improve your writing. Several of the checklist items are discussed in detail in other articles in this issue of Medical Writing, although I provide explanations and examples for each item. I…
Landing the first medical writing job is not easy. Clare Chang’s contribution describes her journey, the challenges she faced, and the different measures she took to overcome these hurdles. EMWA is very much aware of these challenges, as addressed…
Patient-reported outcomes (PROs) are any report on the status of a patient’s health condition as told by the patient him or herself or through an interview, without any interpretation by a clinician or anyone else. They generate information on those…
The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…
The set of reactions being observed in the current coronavirus outbreak is similar to that in other epidemics: the Severe Acute Respiratory Syndrome, the swine flu H1N1 pandemic, and the Middle East Respiratory Syndrome. Indeed, progress has been…
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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