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Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, 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…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

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…

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editors: Louisa Ludwig-Begall, Sarah Kabani Saving the planet, one EMWA conference at a time Author: Adam Jacobs I had been a frequent business traveller for some years until not so long ago. Most of my trips were by plane. I would…

Lifelong learning opportunitites are available for all - Volume 31, Issue

The United Nations Sustainable Development Goals (SDG) call all UN member states– low-, high- and middle-income – to promote prosperity while protecting the environment. The 17 goals are part “of a shared blueprint for peace and prosperity for…

The need for community: The importance of networking as a freelance medical writer - Volume 32, Issue

Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

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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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