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Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

Sound, microphone, action: Podcasts for medical writers - Volume 28, Issue

A podcast is a digital audio file that can be downloaded into your computer or mobile device. It is typically available as a series, and new episodes can be received automatically by subscribers. Podcasts are a source ofeducation, inspiration, and…

History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…

EU software regulations: The new normal or innovation stagnation? - Volume 29, Issue

Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…

Journal Watch - Volume 22, Issue

The August 2013 issue of European Science Editing (ESE), the journal of the European Association of Science Editors, included a couple of articles relating to the San Francisco Declaration on Research Assessment, on which I comment elsewhere in this…

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…

Medical decision making at the individual and population level: The increasing role of evidence - Volume 30, Issue

The major change in medical decision making over the last 50 years has been the realisation that treatment decisions would be improved if doctors’ existing knowledge was supplemented by evidence generated systematically through health services…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

Profile: An interview with Art Gertel on the Budapest Working Group - Volume 24, Issue

Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…

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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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