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What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

Towards electronic product information that meets the needs of everyone: Implications for patients, clinicians, and medical writers - Volume 34, Issue

In an age of increasing digitisation, pharmaceutical product information is evolving. This transformation reflects growing recognition among regulators of the value of patient engagement and widespread societal calls for increased transparency of…

The needs assessment in continuing medical education - Volume 23, Issue

The needs assessment component of a continuing medical education grant proposal document describes why a specific programme should be developed. Medical writers frequently play a central role in producing the needs assessment as an important first…

Setting up and running a medical writing company - Volume 24, Issue

I am the founder and managing director of Scinopsis, a medical writing company based in France. Scinopsis is specialised in providing regulatory documents and medical communications to the pharmaceutical, biotechnology, and medical device…

Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

A rising tide: Hospitals and social media - Volume 21, Issue

The advent of social media has changed the face of healthcare communications. More and more hospitals are recognizing this fact and seeking to integrate tools like Twitter® and Facebook® into their own communications strategies. This article gives…

Medical writing in the Middle East - Volume 22, Issue

Medical researchers in Middle Eastern countries have been forced to confront the fact that scientific publication has become the cornerstone of knowledge dissemination and academic promotion. Regional initiatives, such as the foundation of the…

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…

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…

Strategic medical writing in the post-authorisation phase - Volume 23, Issue

This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…

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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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