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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,…
Observational studies pose a number of biostatistical challenges. Methodological approaches have grown exponentially, but most are rarely applied in the real world. The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative…
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…
As medical writing (MW) is a growing profession in India, we assessed the awareness among professional medical writers (PMWs) about their job and career prospects. We conducted an anonymous survey among PMWs (N=192) working in a global…
Author: Michael Lewis Schneir Section Editors: Wendy Kingdom, Amy Whereat Syntactic punctuation distraction Comma: Over-usage Part 2 Coordinated noncore sentence constituents are likely to be disrupted by unnecessary comma punctuation. Medical…
Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
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…
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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