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Ben Kemp

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The War in Ukraine: the AMR problem

Amidst the ceaseless bloodshed and tragedy endured by the Ukrainian army, a health challenge of international concern continues to fester. This is, of course, in reference to the most fearsome acronym in global health: AMR. The health systems across Ukraine, overwhelmed by the wounded and maimed, provide the unfortunately fertile ground for accelerated antimicrobial resistance. Increased use of antibiotics with…
Ben Kemp
May 6, 2025
Membership NewsMembership News Archive

BIVDA community diagnostics report raised in Parliamentary question

We are pleased to announce that, after writing to the foreword to our recent consensus statement on community diagnostics, Exeter's Labour MP Steve Race asked the following question in Parliament: "To ask the Secretary of State for Health and Social Care, with reference to the report by the British In Vitro Diagnostics Association entitled Unlocking our communities diagnostic potential: the…
Ben Kemp
May 6, 2025
HighlightsHighlights Archive

Majority of pharmacists asked for unnecessary antibiotic prescriptions daily

Pharmacists are regularly confronted with inappropriate requests for antibiotics, with some individuals even stockpiling them for use during holidays despite the growing danger of antimicrobial resistance, according to a recent report. The National Pharmacy Association (NPA), which represents 6,000 independent community pharmacies across England, revealed that pharmacy staff are often asked to supply antibiotics for minor conditions like colds and…
Ben Kemp
May 6, 2025
HighlightsHighlights Archive

Some bacteria already resistant to newest NHS antibiotic

A new study published by the UK Health Security Agency (UKHSA) shows that some bacteria have already become resistant to one of the newest antibiotics introduced to the NHS. Thankfully the levels of resistance are still low, but the data is an important reminder to ensure that antibiotics are used appropriately to slow down the development of resistance. Ceftazidime/avibactam is an antibiotic used…
Ben Kemp
May 6, 2025
HighlightsHighlights Archive

‘Groundbreaking’ dementia blood test trial underway

A major new clinical study aimed at improving dementia diagnosis through blood testing has launched in Surrey, according to a leading charity. The initiative, spearheaded by researchers at Dementias Platform UK (DPUK), is supported by the Alzheimer’s Society, which says the trial seeks to close diagnostic gaps and improve the early identification of dementia. Known as the Blood Biomarker Challenge,…
Ben Kemp
May 6, 2025
Membership NewsMembership News Archive

MHRA fees increase update and action required in DORS

The MHRA have provided an regarding increases in MHRA fees. As outlined in their consultation response in March 2025, the existing one-off medical devices registration fee will rise from £240 to £261 per payable application in DORS. It is expected that this increase will come into effect in Q1 of the financial year 2025/2026. The MHRA has recommended that companies begin preparing for the fee…
Ben Kemp
May 6, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Reminder: Research and Development tax relief advance clearances consultation

Only a few weeks to go until the government's R&D tax relief advance clearances consultation closes. The consultation explores introducing clearances for R&D tax reliefs to reduce error and fraud, enhance certainty, and improve customer experience. The government seeks feedback on whether such a system would achieve these goals and which design or approach would be most effective. R&D Tax…
Ben Kemp
May 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Invitation: TEAM-NB IVDR Technical Documentation Training for Manufacturers – 3 July 2025

Team NB are running a training session aimed at manufacturers requiring EU Conformity Assessment. Team NB represents a number of EU Notified Bodies and works to harmonise the approach taken by the notified bodies when conducting conformity assessments. Sign-up for the 3rd July event here.
Ben Kemp
May 1, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED Plalyground User Guide Updates 20250425

EUDAMED Playground User guide for the UDI Devices module is updated to 3.0.11 as below - Legacy Device Registration: EUDAMED user guide - UDI Device: EUDAMED user guide - Registration of Old/custom-made devices in the Vigilance module: EUDAMED user guide - Vigilance for EOs: EUDAMED user guide - Market Surveillance: EUDAMED user guide
Ben Kemp
May 1, 2025
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