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All Posts By

Ben Kemp

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A new EFLM scientific paper has been published!

Is this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of in vitro diagnostic (IVD) regulation Lord S J, Horvath R, Sandberg S, Monaghan P J, Cobbaert C M, Reim M, Tolios A, Mueller R, Bossuyton P M, on behalf of the EFLM Working Group on Test Evaluation Critical Reviews in Clinical…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

EFLM Meet the Expert – submit your case within 23 February!

6 March 2025 at h. 16.00 CET Interpretation urinalysis tests Moderator: Marielle Kaplan, Israel Learning objectives: Design the diagnostic tests for patients with suspected kidney diseases, haematuria or urinary tract infections together with the clinical units Plan verification of performance for multiple strip tests and particle analysis of urine specimens Interpret urinalysis test results against clinical background, quality of the…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Webinar: Design for the Future: How to Build Sustainable Products That Support Long-Term Success

25 February - 4pm CET Do you know the carbon footprint of your product? Are you ready to provide a digital product passport to regulators? Is sustainability woven into your product design process so you can legally sell in today’s markets? It’s time to get ahead of these demands. Join us for a one-hour webinar uncovering how global regulations like…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming active substance renewals and dossier submission deadlines

Apply for active substance renewal by the deadlines to keep products on the GB market 29 May 2025 5-chloro-2-(4-chlorphenoxy)phenol (DCPP) (CAS 3380-30-1 EC 429-290-0) in product types 1, 2 and 4 27 August 2026 Citric acid (CAS 77-92-9 EC 201-069-1) in product type 2
Ben Kemp
February 21, 2025
HighlightsHighlights Archive

Media Monitoring: 13 – 19 February

At-home test could play key role in type-1 diabetes screening A new home test to diagnose type-1 diabetes (T1D) is being investigated in a major UK study led by researchers at the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre and NDM's Centre for Human Genetics. The study will invite 90 children and young people across…
Ben Kemp
February 19, 2025
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