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Sustainable development, climate emergency, and journalism: The emerging role of medical writers - Volume 30, Issue

The Sustainable Development Goals, set up by the UN in 2015, provide a framework for the policy makers in government and other advocates to work towards planetary health in a more holistic way. For the general public, these goals might not always be…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…

Editorial - Volume 32, Issue

Unsung heroes: The medical writer’s role in clinical trials The medical writer is heavily involved in clinical trials from A to Z and even beyond. Although we are not in the frontline, our role is nevertheless crucial as we develop most of the…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

President's Message - Volume 24, Issue

Dear EMWA Members, As we came together in the historic city of The Hague in November 2015 for another successful and enjoyable conference, we were particularly delighted to welcome our Benelux members who turned out in force. The usual EMWA…

The Light Stuff - Volume 22, Issue

A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations Definitions CTD – Common Technical Document (dossier submitted for marketing authorization) eCTD – Electronic Common Technical Document QC – Quality…

Lingua Franca and Beyond - Volume 25, Issue

In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

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…

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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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