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Cost comparison of salaried and freelance medical writers working in Europe - Volume 23, Issue

This is the first systematic comparison of the costs of salaried and freelance medical writers working in Europe. In the absence of official figures for the total costs of employment, we make reasoned assumptions, using mean base figures for…

O, safety, quo vadis? - Volume 21, Issue

It is widely acknowledged that resolutions of difficulties tend to engender new problems. Increasingly, complex systems perpetuate increasing complexity. This discursive essay suggests that the most promising of discoveries, innovations, and…

Medical writing in India at a crossroads - Volume 22, Issue

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 –…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Consolidated data analysis and presentation using an open-source add-in for the Microsoft Excel® spreadsheet software - Volume 23, Issue

A free and open-source software tool is presented that facilitates the analysis and the visualisation of data in basic life science. Daniel's XL Toolbox is an add-in for the Microsoft Excel® spreadsheet software. It enables scientists to store…

Results of the 2012 EMWA salary survey - Volume 22, Issue

EMWA members were surveyed in late 2012 and early 2013 about their current salary levels. A total of 320 individuals responded. Most were women, between 31 and 50 years of age, and native speakers of English or German. About half had 2–10 years of…

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…

The changing face of medical writing in India - Volume 22, Issue

Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

Getting Your Foot in the Door - Volume 25, Issue

Welcome to Getting Your Foot in the Door or GYFD for short, the latest addition to MEW’s regular sections. It all started at the EMWA 2015 autumn meeting in The Hague. Derek Ho met up with the EMWA Executive Committee (EC) to talk about his idea of…

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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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