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Harold Swanberg, MD: Why and how EMWA should remember him - Volume 32, Issue

Before the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA), there was the Mississippi Valley Medical Editors Association (MVMEA). Most medical writers are unaware of the history of MVMEA and of how it…

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR - Volume 29, Issue

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Position Statement - AMWA-EMWA-ISMP Joint Position Statement on Medical Publications, Preprints, and Peer Review - Volume 30, Issue

In medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and time-consuming process of the…

Medical devices in the disclosure era and the role of medical writers - Volume 26, Issue

AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…

European network for health technology assessment – EUnetHTA - Volume 22, Issue

In 2004, health technology assessment (HTA) was recognised as a ‘political priority’ by the EC and Council of Ministers, which led to a call to establish an effective and sustainable European network for HTA (EUnetHTA). The result was the…

Can access and accessibility rebuild public trust in research? - Volume 31, Issue

Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was…

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

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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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