11:20 am - 12:30 pm Event Series Cultivating a Community of Practice to Ensure the Safe, Effective, and Equitable Use of AI
10:30 am - 11:15 am Event Series Cybersecurity Session: How to Use AI as a Tool to Detect Cybersecurity Breaches
9:10 am - 10:10 am Event Series The Journey to Bringing a Diagnostic Screening Algorithm to Market: Validation, Product Design, and Regulatory Considerations
10:30 am - 11:30 am Event Series Transparency vs. Explainability: Practicalities, Benefits, and Issues
8:00 am - 10:30 am Event Series Notified Body Opinion Workshop – Experiences and Lessons for Combination Products in EU
10:50 am - 2:20 pm Event Series Combination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019
2:40 pm - 5:10 pm Event Series Risk management application in post-market safety & other PMSR Hot topics
9:05 am - 10:05 am Event Series From the Desk of the Office of Combination Products: Strategic Priorities & Action
11:25 am - 12:25 pm Event Series Platform Drug-Delivery Devices: Regulatory and Technical Considerations
2:25 pm - 3:25 pm Event Series Use of Non-integral Medical Devices in Medicinal Product Clinical Studies