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Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA’s Rob Reid pens first MedRegs blog in new role

Following the departure of Laura Squire, Dr Robert Reid, MHRA Deputy Director, will now author the regular MedRegs blog. For the uninitiated, the blog aims to keep readers up-to-date with the progress of the MedTech regulatory reform programme. Dr Reid's inaugural post focuses on staff changes at the MHRA, updated guidance, the progress of the AI airlock, and the PMS…
Ben Kemp
February 25, 2025
Membership NewsMembership News Archive

Reminder: Consultation on TTP on IVD assays for surveillance of Yellow Fever

A reminder that the World Health Organisation has proposed a Target Product Profile (TPP) which highlights the minimal and optimal characteristics required to guide forthcoming efforts in YF assay development and address end user needs. This TPP comprises four types of tests to identify Yellow Fever infections in the context of surveillance: A standardized molecular assay test kit A standardized…
Ben Kemp
February 24, 2025
Membership NewsMembership News Archive

Join the DBT Indo – Pacific Roadshow

Interested in selling to the Indo-Pacific? Want to hear from sector specialists, market experts and other companies about opportunities in the Indo-Pacific? The Made in the UK Sold to the Indo-Pacific: Meet the Experts is a two-week series of in-person events run by the UK Government and partners taking place between 4 - 13 March 2025 in UK cities, including…
Ben Kemp
February 24, 2025
Membership NewsMembership News Archive

Nominations for new BIVDA board members closed, candidates announced shortly

The nominations for candidates to be new BIVDA board members has now closed, with candidates to be announced shortly. This year there will six places available for election, who can be from either Full or Associate Member companies, voted for by our members. We will circulate a form shortly where members are able to vote for their preferred candidates. Please note,…
Ben Kemp
February 24, 2025
Membership NewsMembership News Archive

NICE joins international collaboration on HTA methods research

NICE have partnered with the USA-based Institute for Clinical and Economic Review (ICER) and the Canadian Drug Agency (CDA-AMC) to establish the Health Economics Methods Advisory (HEMA), a new international initiative to research and assess health technology assessment (HTA) methods. HEMA’s aim is to critically and independently research some of the most pressing topics in global health economics and health…
Ben Kemp
February 24, 2025
Membership NewsMembership News Archive

BIVDA and Innovate UK combine to tackle Mpox

Yesterday BIVDA and Innovate UK brought together senior figures from industry, government, and academia to discuss how diagnostics would play a part in an Mpox pandemic. Commissioned by DHSC’s Chief Scientific Advisor and CEO of NIHR, Prof. Lucy Chappell, the group discussed the current and future status of Mpox , available diagnostic solutions, and enablers for pandemic preparedness.  With expert…
Paul Fisher
February 20, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update from BIVDA’s 2025 Regulatory Affairs Seminar

BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA's Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful. We have outlined all updates below: MHRA Fees Consultation – The…
Ben Kemp
February 19, 2025
Membership NewsMembership News ArchiveNear Patient Testing Working PartyNear Patient Testing Working Party Archive

Join the NPT Working Party for CPI partnership plan to accelerate NPT – 6 March 2025

Have you signed up for the latest Near Patient Testing (NPT) working party meeting yet?  On 6th March, BIVDA will be hosting the next NPT working party meeting, in person, at the BIVDA offices. We are pleased to be welcoming CPI, part of UK Government’s Catapult network of innovation centres, to talk about how they have been tasked by the…
Ben Kemp
February 18, 2025
Membership NewsMembership News Archive

BIVDA 2025 Regulatory Affairs Seminar Round-Up

Thank you to everyone who attended BIVDA's sold-out 2025 Regulatory Affairs Seminar and provided excellent feedback. Bringing together regulatory affairs experts from across the globe underlined the importance of  hearing international perspectives, assessing what works and what doesn't, and agreeing on the right direction of travel.medboard Most of all, distilling expertise into a polished two-day event focused on developing regulatory…
Ben Kemp
February 18, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Welsh Government Consultation: Extending the UK Emissions Trading Scheme (ETS) cap beyond 2030

The Welsh Government is seeking views on extending the UK Emissions Trading Scheme (ETS) beyond the end of Phase I (midnight on 31 December 2030). This fulfils the commitment made in December 2023 within the UK Emissions Trading Scheme long-term pathway to consult on the extension of the Scheme. This consultation proposes options and seeks views on: extending the UK…
Ben Kemp
February 18, 2025
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