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Ben Kemp

Consultation – Tackling modern slavery in NHS procurement: proposed regulations and guidance ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Consultation – Tackling modern slavery in NHS procurement: proposed regulations and guidance

The Department of Health and Social Care has launched a consultation and is currently inviting views on the proposed regulations and accompanying guidance. The consultation is seeking views on a wide range of considerations including: how the regulations will be implemented the impact of the regulations on tackling modern slavery how frameworks and dynamic markets (as defined within the Procurement Act…
Ben Kemp
December 17, 2024
Trial finds biomarker test could significantly reduce antibiotic use in sepsis HighlightsHighlights ArchiveSustainability Programme Archive

Trial finds biomarker test could significantly reduce antibiotic use in sepsis

A groundbreaking UK patient trial, led by researchers from the University of Manchester, has demonstrated that using a new biomarker testing protocol for sepsis can enable doctors to safely shorten antibiotic treatment compared to current practices. The study found that reducing treatment duration by approximately 10% could yield significant benefits, including cost savings for healthcare systems, fewer adverse drug effects,…
Ben Kemp
December 17, 2024
UKHSA launches Diagnostics Accelerator HighlightsHighlights ArchiveSustainability Programme Archive

UKHSA launches Diagnostics Accelerator

A specialist team -- the Diagnostics Accelerator -- has been created by UKHSA to rapidly boost the UK's ability to diagnose and test for new and emerging infectious disease threats, aimed at strengthening the UK’s pandemic preparedness and response. The Accelerator seeks to improve the speed at which new and existing types of tests such as lateral flow tests (LFDs),…
Ben Kemp
December 17, 2024
BTOM update – getting it right at the border Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

BTOM update – getting it right at the border

New import controls were implemented on 30 April 2024. This email gives you operational information on the Border Target Operating Model (BTOM). Common Health Entry Documents – Good Practice to reduce delays Estimated Time of Arrival (ETA) in IPAFFS Resources to help you comply Contact points for urgent BTOM queries Common Health Entry Documents   What is a CHED?  A Common…
Ben Kemp
December 16, 2024
Notifying BSI of Changes to PMCF and PMPF plans European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Notifying BSI of Changes to PMCF and PMPF plans

Critical Communication Notifying BSI of Changes to the Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) Plans There is currently a lack of guidance on what constitutes a substantial change to a PMCF/PMPF plan. To address this gap and to provide clarity for our clients, BSI has issued this communication setting out our expectations. For MDR and IVDR devices…
Ben Kemp
December 16, 2024