This session will focus on how the FDA and EMA are shaping AI in life sciences, providing a roadmap for companies to meet evolving regulatory standards. Topics of discuss will include:

• Navigating FDA guidance on AI medical devices, including Predetermined Change Control Plans (PCCPs) and clinical decision support software.
• Exploring EMA alignment with the EU AI Act and its regulations for AI in the life sciences
• Examining case studies showing how companies navigate FDA and EMA directives
• Comparing key differences and similarities between FDA and EMA AI regulations