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Ben Kemp

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Professor Chris Molloy to become BIA CEO from May

The BioIndustry Association (BIA) have announced that Professor Chris Molloy will become their Chief Executive from May 2026. Chris currently serves as the founding Chief Executive Officer of the Medicines Discovery Catapult (MDC), bringing together organisations across academia, industry, the NHS and private capital to drive innovation for patients in the UK and beyond. During the COVID-19 pandemic, Chris was responsible…
Ben Kemp
January 20, 2026
HighlightsHighlights Archive

NICE recommends age-based blood tests for ovarian cancer to improve detection

Under proposed updates from NICE, more cases of ovarian cancer could be identified at an earlier stage by moving away from a uniform blood test threshold and introducing age-specific criteria. The guidance suggests tailoring the interpretation of CA125 test results to a woman’s age rather than applying a single cut-off for everyone. Ovarian cancer affects approximately one in fifty women…
Ben Kemp
January 20, 2026
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA webinar: Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices

The MHRA are hosting a webinar on Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices on Tuesday 3rd February from 2pm - 3pm. During this webinar the MHRA will present guidance and advice to sponsors who are submitting clinical trials with in vitro Diagnostic (IVD) devices. The webinar will be presented in sections including: Clinical Trials with IVDs The…
Ben Kemp
January 20, 2026
Membership NewsMembership News Archive

BIVDA’s Beth and Angela to provide NHS Diagnostics Update: register now

In this 60-minute webinar on Monday 2nd February at 1pm - 2pm, BIVDA's Angela Douglas and Beth Loudon will join NHS consultant Scott McKenzie to explore how Diagnostics is being prioritised, funded and delivered in 2026.   Hosted by the Life Science Access Academy, the panel will cover current NHS policies, including the role of community Diagnostic centres and changes to commissioning routes, and offer practical insight into how Diagnostics suppliers…
Ben Kemp
January 19, 2026
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Researchers find simple blood test can safely stop antibiotic treatment in sepsis patients two days earlier

Researchers from the University of Manchester, led by Professor Paul Dark, have discovered that a simple blood test can inform doctors when it is safe to stop antibiotics in patients recovering from sepsis. The review includes 21 studies involving more than 6,000 patients who underwent blood tests for procalcitonin, a biomarker that becomes elevated during bacterial infections. The analysis was…
Ben Kemp
January 19, 2026
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Less than three weeks to go until BIVDA’s Regulatory Affairs Seminar

There are less than 3 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham and just a few tickets are now remaining. We are pleased to announce that Kim Young, Regional Engagement Director, RAPs will present a session on The Future of Regulatory Affairs. This year's theme is 'Think Locally, Act Globally', dedicating a day…
Ben Kemp
January 19, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For review by 21 January: Weekly ECHA Substance Evaluations

Dear members, please see below list of chemicals flagged as under review for EU CLP by ECHA. MedTech Europe have highlighted the chemicals in yellow as potentially being found in MD/IVDs. Please let me know at regulatory@bivda.org.uk if any of these impact your products. CLP Intention to harmonise classification and labelling – link here:   Pyroxsulam (EC -, CAS 422556-08-9) Proposal…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: GB active substance renewal submission deadlines

Upcoming GB active substance renewal submission deadlines Apply for active substance renewal by the relevant deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active…
Ben Kemp
January 15, 2026
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