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Implications of clinical trial data sharing for medical writers - Volume 22, Issue

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…

What every medical writer needs to know - Volume 23, Issue

A medical writer is never done with learning. In the fast-paced world of online communications, learning means getting involved in the digital environment and using tools like social media, websites, and blogs to enhance your online presence and…

Regulatory Public Disclosure - Volume 32, Issue

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre? - Volume 24, Issue

Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…

Out on Our Own - Volume 25, Issue

In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…

Out On Our Own - Volume 22, Issue

Editorial We hope that you enjoyed the summer months and found time to step away from your desks and relax. This time last year, Kath organised her first ‘Medical Writers’ Retreat’, the aim of which was to provide an opportunity for fellow…

News from the EMA - Volume 30, Issue

First CAR-T cell medicine for mantle cell lymphoma October 16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…

Challenges of working from home during the COVID-19 pandemic: A survey to inform working practices - Volume 30, Issue

In response to the COVID-19 pandemic working practices changed for members of the medical communication community. We devised a multifactorial online survey to better understand the impact of these changes. Of the 759 respondents, 85% had a positive…

The medical writers role in health technology assessment submissions - Volume 30, Issue

Writing health technology assessment (HTA) submissions is a challenging and rewarding area of medical writing, being part of the process of giving patients access to new medicines. Submission requirements differ between countries but all require…

Mentors and mentees in medical writing: A very particular set of (soft) skills - Volume 33, Issue

Being a mentor or a mentee can be fulfilling and rewarding. In this article, we look at the role and relationship of mentors and mentees, and the importance of using soft skills within the mentor/mentee dynamic. Individually tailored and productive…

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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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