In this session, we will be addressing the regulatory advances and evolving expectations surrounding the integration of Artificial Intelligence (AI) and Machine Learning (ML) in Quality Risk Management (QRM). This presentation will provide a comprehensive overview of recent regulatory developments that shape the use of AI and ML, ensuring compliance and enhancing the robustness of QRM frameworks. We will also discuss the potential benefits these technologies bring, including improved accuracy in risk assessments, enhanced predictive capabilities, and optimized quality. Attendees will gain valuable knowledge on how to align with regulatory expectations while leveraging AI and ML to achieve superior risk management outcomes and drive innovation within their organizations.