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Events listed on BioOhio's Events Calendar are subject to change by the Event Organizer. Visit the organizer's website for current details.

Xavier Combination Products Summit 2021

September 23 - October 1

Xavier Health presents the 2021 Combination Products Summit – Solutions for a dynamic industry with evolving regulations


Sprint 1 (9/23/21, 10am-2pm ET):

  • Office of Combination Products: Strategic Priorities and Action

  • Platform Approaches: Key Considerations Across the Combination Product Lifecycle

  • Strategies for Combination Product Bridging

  • Development and Regulatory Considerations for On-Body Injector Combination Products

Sprint 2 (9/24/21, 10am-1:50pm ET):

  • The Global Regulatory Landscape of Combination Products

  • Quality and Regulatory Considerations for Combined Use Digital Health Solutions and Medicines

  • Covid Innovation and Lessons Learned

Sprint 3 (9/30/21, 10am-2pm ET):

  • Combined Use and Cross-Labeled Products: Overcoming Investigational Challenges

  • Digital Companion Diagnostics – Considerations for Future Combined Use Software and Pharmaceutical Products

  • Current Thinking on Essential Performance Requirements (EPRs)

  • Current Approaches to Human Factors Studies for Combination Products

Sprint 4 (10/1/21, 10am-2pm ET):

  • Regulatory Expectation for Reliability and Robustness of Combination Products

  • Combination Product Post-Approval Changes: FDA Expectations for Supportive Device Data

  • Post Market Safety Reporting (PMSR) Requirements: Post Implementation Impact!

  • Fireside Chat with FDA

Click here for more information


Online Event
OH United States


Xavier Health
(513) 745-3020
View Organizer Website