In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance…
Building on the broader Life Sciences Vision, this high-level document reviews the current UK medtech landscape and identifies and prioritises the areas for action. This strategy will form the basis of future implementation plans that will set out in detail…
Increasingly, we are seeing an uptake in applications of artificial intelligence (AI). The use of AI has the potential to make a significant difference to society. However, to realise the benefits, there needs to be confidence that AI is being…
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice). It…
The Commission wants to ensure people are empowered to fully enjoy the opportunities that the digital decade brings. So, it proposed a set of European digital rights and principles that reflect EU values and promote a sustainable, human-centric vision for…
The UK has encouraged frontier AI organisations to publish details on their frontier AI safety policies ahead of the AI Safety Summit 2023. This document complements those AI safety policies by providing an overview of emerging frontier AI safety processes…
Artificial Intelligence (AI) can help us address some of the world’s biggest challenges. It can enable doctors to improve diagnoses and develop therapies for diseases for which none exist yet; it can reduce energy consumption by optimising resources; it can…
The portfolio of AI assurance techniques has been developed by the Centre for Data Ethics and Innovation (CDEI), initially in collaboration with techUK. The portfolio is useful for anybody involved in designing, developing, deploying or procuring AI-enabled systems, and showcases…
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