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Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD - Volume 32, Issue

Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

HIV research fraudster handed stiff prison sentence - Volume 24, Issue

In the December 2014 issue of Medical Writing, I reported that disgraced Iowa State University researcher Dong-Pyou Han was facing fraud charges for faking experiments on a new HIV vaccine.1 In spite of a guilty plea, on 1 July 2015 Dr Han was…

In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

President's Message - Volume 24, Issue

Dear EMWA Members, As we came together in the historic city of The Hague in November 2015 for another successful and enjoyable conference, we were particularly delighted to welcome our Benelux members who turned out in force. The usual EMWA…

History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…

Mind the gap – towards complete and transparent reporting of animal research - Volume 26, Issue

Several initiatives have been taken to standardise the reporting of animal studies in peer-reviewed scientific journals, such as the ARRIVE (Animal Research: Reporting of In Vivo Experiments) and GSPC (Gold Standard Publication Checklist)…

Your professional association: A great way to expand your skills and advance your career - Volume 22, Issue

Many medical writers and translators are not members of professional associations. While online networking is clearly accepted as a key element for success in business, the benefits of joining associations are still not obvious to all, even though…

Biosimilars: Change, challenge, and accomplishments - Volume 28, Issue

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…

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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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