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Join NICE for the online launch of its Real-World Framework

NICE are hosting a launch event for its ‘Real-World Framework’ which describes best practices for the planning, conduct, and reporting of real-world evidence studies. The framework aims to improve the quality of real-world evidence informing NICE guidance. Real-world data refers to data collected outside of highly-controlled trials. It can come from many different sources including patient health records, administrative records,…
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May 13, 2022
Membership NewsMembership News Archive

Life Sciences Innovative Manufacturing Fund: Phase 1, Wave 3

If you are interested in submitting an expression of interest in the Life Sciences Innovative Manufacturing Fund, you must complete your application by Tuesday 31st May at 12pm. Members should apply as early as possible as funding allocation is finite. The Life Sciences Innovative Manufacturing Fund provides £60 million in capital grants for investments in the manufacture of: human medicines,…
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May 13, 2022
Membership NewsMembership News Archive

Clean Air Day 2022

People are dying from air pollution, and this includes indoor as well as outdoor pollution. The figures from the World Health organisation are a staggering 7 million people worldwide! The UK figures are 36,000 people each year dying form heart and lung disease caused by air pollution. Global Action Plan is an environmental charity. They are behind the Clean Air…
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May 13, 2022
Membership NewsMembership News Archive

BIVDA attends the MedTech Forum 2022 event in Barcelona

BIVDA attended the MedTech Forum 2022 event in Barcelona this week to link in with European IVD and medtech counterparts and stakeholders. The event comprised varying discussions sessions featuring CEO leaders, policy experts, medtech & diagnostics innovators and regulatory affairs specialists. There were plenty of networking opportunities to discuss topics relevant to the pace of IVDR implementation, innovation in digital…
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May 6, 2022
Membership NewsMembership News Archive

Sustainability challenges across the EU and UK

As an industry, the targets set particularly with regard to Net Zero, the Green Deal, the Corporate Sustainability Due Diligence and waste regulations across the EU further demonstrate that Sustainability is something that must be addressed globally, and regardless of the mechanism the administrative body is using, the challenges, processes and solutions are the same. Whilst in the UK the…
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May 6, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

MDCG has published guidance on significant changes under the IVDR

These updated transition periods mean that organisations do not need to conform to the full scope of the IVDR dependent on the risk classification of their product, but also ‘freezes’ the product as significant changes cannot be made to the product during this period. Where significant changes are made, the product must conform to the full scope of the IVDR…
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May 6, 2022
Membership NewsMembership News Archive

Neale Hanvey MP: adjournment debate on the UK diagnostics industry and the global COVID-19 recovery

Members may be interested to note that Neale Hanvey MP will be holding an adjournment debate on the “UK diagnostics industry and the global COVID-19 recovery” on Tuesday May 10 2022 at 11:30 am in the Commons Main Chamber. Neale has long been a strong advocate for the UK diagnostics industry, particularly during the pandemic, and has often raised issues…
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May 6, 2022
HighlightsHighlights Archive

Babies in England to receive eye cancer test in the womb

A new life-saving test which detects eye cancer in babies is being launched across England by the NHS this week. Developed at the Birmingham Women’s and Children’s NHS Foundation Trust, the test will be able to spot the rare cancer retinoblastoma while babies are still in the womb. By spotting the cancer sooner, the babies can be treated earlier, thus…
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May 6, 2022