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Ben Kemp

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Government launches new Genomic Population Health Service

The Government has announced a new genomics population health service, with NHS staff being trained to identify patients eligible for genomic testing. At the heart of this initiative, nurses will lead the way as local genomics champions — helping patients access faster, more accurate diagnoses closer to home, alongside vital support and counselling where needed. The new service will build…
Ben Kemp
September 1, 2025
Events DiaryMembership NewsMembership News Archive

OLS £520m Life Sciences Innovative Manufacturing Fund (LSIMF) webinar for BIVDA members

We would like to invite members to register for this exclusive 30-min webinar for BIVDA members led by the OLS's LSIMF team on the £520m Life Science Innovative Manufacturing Fund this Friday 5th September at 12pm - 12:30pm. This fund is designed to: - Strengthen the UK’s life sciences manufacturing capacity and capability - Boost health resilience - Unlock significant…
Ben Kemp
September 1, 2025
Near Patient Testing Working PartyRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK MHRA CDx guidance for clinical trials updated 22AUG2025

Dear members, following our feedback to the MHRA, on August 22nd the Clinical Trials Guidance page on gov.uk was updated. The update includes specifics of trial submission when companion diagnostics are involved in GB. Separate IVDR related guidance applies to trials conducted in Northern Ireland. Thanks to Alison Gillies, Leica Biosystems who spotted and reported the update, which I don’t…
Ben Kemp
August 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

A Deep Dive into Regulatory Intelligence in Europe

Advance with Insight. Lead with Intelligence. In an era of accelerated innovation and ever-changing global requirements, regulatory intelligence requires more than just knowledge — it demands foresight. The 2025 Regulatory Intelligence Conference Europe, an immersive two-day conference hosted by TOPRA and RAPS, is designed to equip you with the strategic insights and tools to stay ahead. Here’s a sneak peek…
Ben Kemp
August 28, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

TGA – Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs)

We are resharing this update from earlier in the year: TGA - Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs) Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA) Mentions CE to the directives and the regulation for…
Ben Kemp
August 28, 2025
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