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Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Lingua Franca and Beyond - Volume 27, Issue

“What is written without effort is, in general, read without pleasure”.

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…

Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

Getting Your Foot in the Door - Volume 27, Issue

One of the most challenging questions faced by academic life scientists at some point in their career is whether to pursue research or to look for suitable positions within industry. While the shift from academia to industry might result from a…

Medical journalism in a new era - Volume 30, Issue

We are living at a time when the general public is increasingly interested in scientific and medical advances. Medical journalism is therefore becoming more important to medical writers, although it is a subject that few of us are familiar with. To…

EMWA News - Volume 30, Issue

In September 2021, the editors-in-chief of over 200 biomedical and scientific journals from all geographic regions issued a call for Emergency Action to Limit Global Temperature Increases, Restore Biodiversity, and Protect Health.1 This editorial…

Medical Devices - Volume 27, Issue

The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…

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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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