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BIVDA launches new genomics whitepaper

Hot off the heels of our COVID-19 report, BIVDA have now released a new genomics whitepaper – marking our second report launch in as many weeks. The genomics whitepaper titled, ‘Leveraging advanced diagnostics to realise the UK's potential in genomics: A new whitepaper’, examines the UK genomics landscape, with a focus on patient access to genomic testing. The independent report,…
Dawn
May 19, 2023
Membership NewsMembership News Archive

Meet Tehelj, BIVDA’s new Regulatory Affairs Officer!

We are pleased to announce that we have appointed a new Regulatory Affairs Officer, who has begun working with us full-time from May 4, 2023. Tehelj joined us from Omega Diagnostics where she worked closely with partners, suppliers and distributors in support of creating labelling policy, product labels and translations. Her experience includes authoring high quality technical files and clinical…
Dawn
May 12, 2023
Membership NewsMembership News Archive

BIVDA shortlisted for two prizes at the 2023 Memcom Excellence Awards

We are delighted to announce that BIVDA has been nominated for ‘Best Trade Association’ and the ‘Memcom Sustainability Award’ at the 2023 Memcom Excellence Awards. The shortlist was announced at the Memcom Spring Party on Thursday, which was attended by Regulatory Affairs Manager, Ashleigh Batchen and Operations Manager, Natalie Creaney. We are proud that the efforts of our small but…
Dawn
May 12, 2023
Membership NewsMembership News Archive

Ashleigh named an ‘In Vivo Rising Star 2023’ by Pharma Intelligence

BIVDA is proud to announce that BIVDA’s Regulatory Affairs Manager, Ashleigh Batchen, has been named by Pharma Intelligence as an ‘In Vivo Rising Star’. This annual list names 30 rising leaders across the biopharma, medtech and health technology sectors. The honour is bestowed on rising leaders of all ages, making Ashleigh’s designation even more impressive given she is merely at…
Dawn
May 12, 2023
Membership NewsMembership News Archive

Oncology Accelerator launched by UKRI – apply today!

Innovate UK is launching an Oncology Accelerator as part of its Cancer Therapeutics programme which aims to unleash business-led innovation from the UK’s vibrant research base. The Accelerator is open to applications from UK organisations developing broad innovations in the field of oncology. Successful applicants will benefit from an intensive five-month programme supporting them to tell a compelling story to…
Dawn
May 12, 2023
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA survey on PMS costs – deadline 17 May

To better understand the implications of proposed Post Market Surveillance (PMS) to manufacturers of medical devices, the MHRA would like to be provided with data on firms' expected cost of compliance with PMS regulations so far. This survey covers total costs of setting up a PMS system across an organisation, and the cost of maintaining a PMS. This firm level…
admin
May 5, 2023
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKCA statutory instrument published on implementation timelines

  The UK Government have published an amendment to the UK Medical Device Regulations 2002. Notably, this is the first statutory instrument shaping the new UKCA requirements in Great Britain. BIVDA have provided our initial understanding of this text below. Please consult your own legal teams before acting on any of this advice, as it is our own interpretation. We…
admin
May 5, 2023
Membership NewsMembership News Archive

The UK Export Academy events

  The UK Export Academy from the Department of Business and Trade gives businesses the know-how to sell to customers around the world by learning from experts in international trade. The UK Export Academy has been designed to accommodate different levels of exporting experience, whether your business is interested in starting to sell internationally or looking to grow your international…
Natalie Creaney
May 5, 2023
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