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Cosmetic regulatory writing - Volume 23, Issue

On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…

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)…

An interview with Research Policy and Initiatives Director Roseline Favresse at the European Organisation for Rare Diseases - Volume 34, Issue

Roseline Favresse is the Research Policy and Initiatives Director at the European Organisation for Rare Diseases (EURORDIS). We interviewed Roseline to learn more about the rare disease landscape within Europe and the exciting recent collaborations…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

Editing - Volume 27, Issue

Medical writing is an umbrella term that involves not only writing but also editing and translating medical texts between different languages. While some of us will work specifically as editors in medicine or science, editing skills are paramount to…

Regulatory Writing Developments in paediatric regulation - Volume 22, Issue

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…

French breast implants, the Medical Device Regulation, and a theoretical case study - Volume 26, Issue

Abstract The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when…

New documents required by the medical device regulation - Volume 29, Issue

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…

Regulatory medical writing in Switzerland - Volume 22, Issue

Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…

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…

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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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