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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),…
A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations Definitions CTD – Common Technical Document (dossier submitted for marketing authorization) eCTD – Electronic Common Technical Document QC – Quality…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
Whether you’re an early adopter, an occasional user, or yet to acknowledge its transformative potential, artificial intelligence (AI) – specifically generative AI applications underpinned by large language models – is undeniably shaping our present…
Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…
Dear all,In this issue, Rossella Ferrari tackles the elephant in the room – how do medical writers manage to find time for their continuing professional development whilst still keeping their head above water with their ongoing project work?We all…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
Editorial Kimi Uegaki (section editor) Medical Writing. 2023(3):105. Why environmental sustainability requires us to focus on our handprint – and write about it Egid van Bree (author) Environmental sustainability has gained increasing attention…
What can I say? I am excited to be writing my first editorial as section editor of EMWA News. With Bea as my predecessor, I know I have some big shoes to fill and hope to be up to the task. In this issue, we share the latest news from our…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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Alicia Brooks Waltman
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AI/Automation
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Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
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Medical Devices
My First Medical Writing
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Regulatory Matters
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
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Chris Monk