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This book is regarded by many as the holy grail of reference manuals. For those not familiar with the great tome it contains a massive amount of information regarding ‘publication style and format for scientific papers, journal articles, books, and…
September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…
A skilled mentor can positively impact a mentee’s personal and professional development. A successful mentor-mentee relationship is contingent on mentor and mentee attributes, trust, and respect, and fit based on shared values and working style. To…
Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…
Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…
Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…
Another summer has come and gone. In this issue of OOOO, we are happy to feature Paul Woolley's novel approach of comparing employment and freelancing. I am sure many of us can identify with some of the points he raises. We thank Debbie Jordan for…
Vaccines and immunotherapies are among the largest categories for pharmaceutical products, meaning that many medical writers will work in this field. For people new to this area, we describe the basics of how vaccines and immunotherapies work.
Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…
Patient-reported outcomes (PROs) are an essential element to demonstrate the value of a health intervention. In many ways, PROs represent the ultimate “real-world” data, yet the drive towards “Big Data” has focused onroutinely collected data from…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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