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For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…
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),…
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…
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…
Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…
Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…
Successive waves of COVID-19 have altered opinions and working practices. We conducted a survey in early 2020 among 759 members of the medical communications community, recruited via our network, seeking their experiences, opinions, and insights.…
The integration of Equity, Diversity, Inclusion, and Belonging (EDIB) principles within the field of medical communications is of paramount importance. EDIB principles, aligned with global guidelines on sustainability – encompassing labour…
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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