Thirty years ago, the landscape of MRI research and clinical trials was a very different world compared to the complex regulatory environment we navigate today. Back then, conducting an MR study required little a few A4 page sized proposal submitted to the local ethics committee here in Bern. It was a time when innovation flourished… Continue reading Background of this Blog: Personal Experience
Tag: Swissmedic
Swissmedic: Switzerland’s regulatory authority for therapeutic products, ensuring safety, efficacy, and quality in healthcare.
Demystifying the Investigator’s Brochure: A Comprehensive Guide to Preclinical Testing, Device Interactions, and Regulatory Compliance for Swissmedic and KEK Submissions
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Revision of Human Research in Switzerland — The Revised HRA Ordinances
Switzerland has taken a significant step forward in regulating human research with the revision of the Human Research Act (HRA) ordinances. Approved by the Federal Council, the updated ordinances, designed to reflect advancements in digitalization, national and international standards, and research practices, officially came into effect on 1 November 2024. However, provisions on transparency will… Continue reading Revision of Human Research in Switzerland — The Revised HRA Ordinances
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