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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…

In the Bookstores - Volume 23, Issue

To satisfy the inquisitive mind, Oxford University Press has since the year 2000 published books offering ‘A Very Short Introduction’ to a whole range of subjects. For example, 2013 saw the publication of introductory guides to, among other topics,…

In the Bookstores - Volume 27, Issue

An Introduction to Pharmac - ovigilance is a compelling read and one that both new and experienced medical writers will find useful for providing a suc - cinct, yet thorough, overview of today’s current drug safety requirements. Patrick Waller and…

News from the EMA - Volume 30, Issue

Medical writers at EMA have published an “EMA medical terms simplifier” (https://www.ema.europa.eu/en/documents/ot her/ema-medical-terms-simplifier_ en.pdf) on the “Glossaries” page of EMA’s website (under “About us”) to provide public-friendly…

Patient education accessibility - Volume 24, Issue

Patient education that overcomes literacy barriers supports quality care. This article provides an overview of health literacy, describes the concepts of readability and accessibility, and discusses how to empathise with the patient's experience and…

Get your (visual) act together: Optimising the design of labels and arrows in medical illustrations - Volume 29, Issue

There is an enhanced communicating power of text when associated with visuals. This is a compelling argument for furnishing medical writers with basic knowledge on how to adapt and create simple figures. This article discusses tips on adding labels…

Guidelines for disclosing the results from observational trials - Volume 26, Issue

Observational trials are a relevant part of clinical research. Publishing their results can be challenging for scientists and writers. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement was the first…

Ins and outs of environmental risk assessments (ERA) of medicinal products for human use - Volume 31, Issue

An environmental risk assessment (ERA) is the process of evaluating the effects of drugs for human use on the environment. ERAs must accompany all new drug market authorisations in Europe. In this article, we discuss the current guidelines on ERAs…

Blockchain in healthcare, research, and scientific publishing - Volume 28, Issue

Data are being transmitted and stored on cloud-based networks, including clinical, research, and publishing data. These cloudbased systems often lack comprehensiveness, accessibility, interoperability, confidentiality,accountability, and…

Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…

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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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