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News from the EMA - Volume 32, Issue

This roundup of news from the EMA includes information on vaccines to protect against dengue, therapy to treat transplant patients with post-transplant lymphoproliferative disease, the withdrawal of marketing authorisations for amfepramone…

In this issue… The Medical Writing Business - Volume 24, Issue

As medical writers, we strive not just to survive but to thrive. Threats, opportunities, and complications come from many directions, and how to best position ourselves, our departments, and our companies requires much thought. Money is important…

Health economists and medical writers: Collaboration or collision? - Volume 22, Issue

Medical writers are perceived by many health economists to be incompetent in health economics writing. Medical writers need to abolish this common perception, and so must develop an understanding of cost-effectiveness, cost-utility, and other health…

Medical affairs writing: A key role to relay medical information to everyone - Volume 25, Issue

Medical Affairs is a link between the scientific and marketing units of a pharmaceutical company. Medical writers in this field are responsible for writing varied document types from regulatory reports to scientific publications, and marketing…

Why clinical study reports really matter - Volume 27, Issue

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available…

Regulatory Writing: Authorship issues in regulatory documents - Volume 25, Issue

When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…

In the Bookstores - Volume 28, Issue

Yellowlees Douglas is a con sult - ant on writing and organisations and an associate professor in the Center for Management Com - munication at the University of Florida, USA. Maria B Grant is a professor of ophthalmology at the University of…

Social media and the rise of predatory journals: A case report - Volume 30, Issue

This is a report of our experience with a predatory journal that invited us to join them after having seen our winning essays on how to identify predatory journals. We applied the system we recommended therein to investigate the true nature of the…

Connecting through screens: Navigating relationships with patients and advocacy groups in a digital world - Volume 33, Issue

As a Healthcare Publications Editor at Karger Publishers, I write, edit, and oversee the development of patient information resources in our Fast Facts for Patients series. Soft skills are vital in my role at Karger, where we are committed to…

Editorial - Volume 27, Issue

A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.

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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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