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How can we maximise patient engagement with Plain Language Summary of Publication articles (PLSPs)? A publisher’s perspective - Volume 33, Issue

Plain Language Summary of Publication articles (PLSPs) are aimed at non-specialist audiences, using non-technical/jargon-free and easy to understand language to provide summaries of publications. The introduction of PLSPs has added to the growing…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

The Crofter: Sustainable Communications - Volume 32, Issue

Editorial Kimi Uegaki (section editor) Medical Writing. 2023(3):105. Why environmental sustainability requires us to focus on our handprint – and write about it Egid van Bree (author) Environmental sustainability has gained increasing attention…

News from the EMA - Volume 30, Issue

February 26, 2021 – EMA has recommended granting a marketing authorisation in the European Union (EU) for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic…

HIV vaccine clinical trials: An overview - Volume 27, Issue

More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

AI language models are transforming the medical writing space – like it or not! - Volume 32, Issue

Whether you’re an early adopter, an occasional user, or yet to acknowledge its transformative potential, artificial intelligence (AI) – specifically generative AI applications underpinned by large language models – is undeniably shaping our present…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

How FAIR are pharma publication data? - Volume 31, Issue

Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important…

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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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