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Editorial Welcome to the Translation Section editorial! What we call ‘lay-friendliness’ is a key characteristic of Patient Information Sheets (PIS), which are tightly regulated on a European level to guarantee a comprehensible document that…
Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…
Dear EMWA Members, As you are well aware, we have been celebrating our 25th anniversary as an organisation and have sent out specially designed buttons with the December issue of Medical Writing to commem - orate the occasion. To continue the…
The Chinese medical regulatory writing and medical science writing landscapes are chang - ing rapidly. Changes in regulatory reforms continue as China further strives to align its pharmaceutical industry with the world, which necessitates…
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…
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
Insulin was first purified in 1921 by Frederick Grant Banting and Charles Herbert Best at the University of Toronto. Soon after, the benefits of using insulin to treat diabetes was discovered, the patent was sold to the University of Toronto for $1,…
Data are being transmitted and stored on cloud-based networks, including clinical, research, and publishing data. These cloudbased systems often lack comprehensiveness, accessibility, interoperability, confidentiality,accountability, and…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
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…
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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