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The article discusses the governance of artificial intelligence (AI) and machine learning (ML) in pharmacovigilance, highlighting the significant potential benefits and challenges of their implementation. It emphasizes the need for robust governance frameworks, accountability, and compliance with regulatory standards to ensure patient safety and trust in medicines. The authors propose a structured approach for managing AI/ML in pharmacovigilance, including roles, responsibilities, risk management, and valid

Author

hammami khouloud

Language

EN