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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…

Beyond limits – Leading at the Edge - Volume 30, Issue

Every member of a working group or a team has a defined role, such as that of a leader or a mentor. Although every role has its own distinct definition, a great mentor can be a great leader and vice versa. One of the finest mentor leaders, explorer…

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…

The COVID-19 pandemic as a catalyst for digitalisation and remote working in Germany - Volume 31, Issue

Remote working is ideal for medical writers, but up until a few years ago, was not widely available to those looking for a remote position with a German employer. Even though Germany is a developed country, its digitalisation has long been lagging,…

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout Traversing the social media landscape: Digital health communications in 2024 Author: Shannen Young Amidst a post-pandemic landscape marked by dis- and misinformation, new technologies, and platform shifts,…

Combined workshops on medical writing and publication ethics for Japanese postgraduate students and faculty members - Volume 22, Issue

Although the importance both of skills in medical writing in English and of an understanding of ethics in medical publishing is increasingly recognised, these subjects are not comprehensively taught to Japanese medical doctors and students. Limited…

Medical writing for cancer trials and submissions - Volume 21, Issue

Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…

The evolving landscape of medical education in oncology - Volume 21, Issue

The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…

Identifying appropriate journals in which to publish original research on vaccines against human infectious diseases - Volume 21, Issue

The most effective way of communicating new research findings is by publishing them in a peer-reviewed journal which is widely read and highly respected. To ensure that important new data are shared with the appropriate audience in a timely manner,…

Out On Our Own - Volume 21, Issue

Another summer has come and gone. In this issue of OOOO, we are happy to feature Paul Woolley's novel approach of comparing employment and freelancing. I am sure many of us can identify with some of the points he raises. We thank Debbie Jordan for…

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Scope

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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