Angel Buendia
Knowledge Manager, Scilife
With 20+ years of experience shaping quality within pharmaceuticals, Ángel bridges QC & QA expertise in life sciences. His passion for continuous learning, combined with his role as a Smart Quality advocate, drives his dedication to instilling a quality culture, guiding teams with collaborative leadership, and fostering excellence as a cornerstone. He navigates complex regulations, and is driven by upholding high standards and fueling innovation.
The European Commission keeps a public repository of AI literacy practices. Real programmes from real organisations, published so you can copy what works. There are forty-odd entries, filterable by sector.
Quick answer Draft Annex 22 is the EU's proposed GMP guidance for data-trained AI and machine learning (AI/ML) models used in critical pharmaceutical manufacturing applications. It introduces AI-specific expectations for governance, validation, risk ...
From finding promising drug candidates to optimizing clinical trials and scaling up manufacturing, AI is reshaping the entire drug development journey, leading to faster development, lower costs, shorter timelines, and, most importantly, quicker acce...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices, and the regulatory landscape has moved fast to keep pace.
At the time of this updated blog post, regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are in place. Since 2023, the conversation has shifted decisively from "what should the rules for AI be?...
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