Combination Products Summit

Topics

• Platform Approaches: Key Considerations Across the Combination Product Lifecycle
• Office of Combination Products: Strategic Priorities and Action
• Development and Regulatory Considerations for On-Body Injector Combination Products
• Strategies for Combination Product Bridging
• Quality and Regulatory Considerations for Combined Use Digital Health Solutions and Medicines
• The Global Regulatory Landscape of Combination Products
• Combined Use and Cross-Labeled Products: Overcoming Investigational Challenges
• Covid Innovation and Lessons Learned
• Current Thinking on Essential Performance Requirements (EPRs)
• Digital Companion Diagnostics – Considerations for Future Combined Use Software and Pharmaceutical Products
• Regulatory Expectation for Reliability and Robustness of Combination Products
• Current Approaches to Human Factors Studies for Combination Products
• Post Market Safety Reporting (PMSR) Requirements: Post Implementation Impact!
• Combination Product Post-Approval Changes: FDA Expectations for Supportive Device Data
• Fireside Chat with FDA