Quick answer The EU AI Act is the European Union's risk-based regulation for artificial intelligence. It applies to organizations that develop, provide or use AI systems, including pharmaceutical, biotechnology and medical device companies. Complianc...
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 ...
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