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In the Bookstores - Volume 21, Issue

Changes and developments in working lives during the next decades The author of the book The Shift, The Future of Work is Already Here, Lynda Gratton, is a professor of management practice at the London Business School. She has been nominated…

In the Bookstores - Volume 22, Issue

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…

Participant information – an ethics committee view - Volume 29, Issue

The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of…

News from the EMA - Volume 26, Issue

November 15, 2016 — The EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The…

Out on Our Own - Volume 30, Issue

Editorial Welcome readers, I’ve lost count how many times people ask me, what is a medical writer? And it isn’t just my mum and aunt who ask me such a question; medical doctors, PhD students, and academic professors are often surprised that…

French breast implants, the Medical Device Regulation, and a theoretical case study - Volume 26, Issue

Abstract The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when…

Staying ahead of the game in the changing arena of ethical medical communications - Viewpoint of a freelance medical writer - Volume 25, Issue

Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

The Webscout - Volume 26, Issue

Medical devices range from things as simple as an injection needle to implantable pacemakers and MRI imaging devices. A video by the WHO (http://t1p.de/WHOVideo) gives you an impression of the variety of medical devices and their importance for…

Reporting health economic evaluations: CHEERS and beyond - Volume 30, Issue

Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…

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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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