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
8:15 am - 9:15 am Event Series Navigating Combination Product Pathways: Industry Experiences and FDA’s Role
9:15 am - 10:05 am Event Series Building Clarity to Address Regulatory Challenges of On-Body Delivery
10:25 am - 11:40 am Event Series Part 1 – Bridging and leveraging human factors data in drug-device combination products development. Part 2 – Q&A and Discussion of Final Guidance of Application of HF Engineering Principles for Combination Products
11:40 am - 12:40 pm Event Series Navigating the New Frontier in Cybersecurity: Technical and Regulatory Considerations for Managing Cybersecurity Risks for Combination Products