Module 12 Presentations

07/02/2024

The Challenge of Artificial Intelligence Compliance

• WARNINGS! • One approach cannot work for all AI systems / types / industries • There is a lot of information regarding Regulations / Standards / Guidance's etc and too many examples of these texts conflicting • FDA guidance on AI is only DRAFT – there is no US Law on AIs • The EU has not determined how the EU AI Act will interact with other Regulations – does the EU AI Act hold more sway than the EU MDR / Pharma Regulation? Which takes precedence? • AI Bias due to skewed training data is a massive concern

The Organisation for Professionals in Regulatory Affairs

19

The Challenge of Artificial Intelligence Compliance

• WARNINGS! • One approach cannot work for all AI systems / types / industries • There is a lot of information regarding Regulations / Standards / Guidance's etc and too many examples of these texts conflicting • FDA guidance on AI is only DRAFT – there is no US Law on AIs • The EU has not determined how the EU AI Act will interact with other Regulations – does the EU AI Act hold more sway than the EU MDR / Pharma Regulation? Which takes precedence? • AI Bias due to skewed training data is a massive concern

The Organisation for Professionals in Regulatory Affairs

20

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