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The medical writing landscape in China - Volume 28, Issue

The Chinese medical regulatory writing and medical science writing landscapes are chang - ing rapidly. Changes in regulatory reforms continue as China further strives to align its pharmaceutical industry with the world, which necessitates…

Document management systems for medical writing - Volume 28, Issue

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…

Thriving (and not just surviving) in a VUCA healthcare industry - Volume 28, Issue

VUCA stands for volatility, uncertainty, complexity, and ambiguity. The healthcare sector is considered a VUCA industry, constantly changing through rampant mergers and acquisitions, rapidly evolving regulations, and leading-edge innovations. So how…

Implantable medical devices: Preclinical testing in new product development – on the road to clinical reality - Volume 31, Issue

Implantable medical devices (IMDs) have restored viable and meaningful lives to millions of people who would have otherwise continued to be severely restricted or suffered early death due to their pathologies. Research and development of IMDs are…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

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…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

Writing narrative style literature reviews - Volume 24, Issue

Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…

A survey on current use of software tools for systematic literature reviews - Volume 32, Issue

Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…

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Scope

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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