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Books to support your medical writing journey - Volume 32, Issue

On your journey as a medical writer, you will need many types of books: style guides, dictionaries, thesauruses, books about language and grammar, and books about how to be a medical writer. This article is not about these books – it is about the…

Intelligent use of artificial intelligence for systematic reviews of medical devices - Volume 28, Issue

Systematic literature reviews are an essential component of the medical device clinical evaluation process. The EU Medical Device Regulation requirement for regularly updated systematic literature searches will increase the burden on the medical…

Pesticide dossiers, an opportunity for medical writers - Volume 23, Issue

Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a…

Regulatory Writing - Volume 23, Issue

Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately…

Protecting the rights of clinical trial patients through disclosure: The significance of plain language - Volume 27, Issue

Taking a step back to understand the history of clinical trial regulation triggers a broader perspective on the work we do or the work we will do. As regulatory medical writers, our role is often limited to the more technicalsubmission-level…

Regulatory Writing: Authorship issues in regulatory documents - Volume 25, Issue

When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…

News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD - Volume 32, Issue

Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…

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…

Never say never! Returning to full-time employment after freelancing - Volume 25, Issue

Alison McIntosh successfully operated as a freelance medical writer for 14 years and gave up the ‘flexible lifestyle’ of a selfemployed freelance medical writer to become a full time employee. She has joined a growing band of ‘decentralised’ office…

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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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