Xavier is well known for its work in Combination Products. The summit allows attendees to interact with FDA and industry experts, network with colleagues, and share challenges. Attendees learn how product approval can be accelerated through new streamlined FDA processes and work through an advanced case study. There will be opportunities to participate in deep-dive sessions with the experts and create actions plans that can be implemented immediately.
Suzanne O'Shea will speak on three panels, Foundations of Combination Products - Setting the Stage; Post-Market Changes for the Combination Product; and Case Studies: Global Regulatory Strategies for Combination Product Registration and Change Management. Scott Thiel will moderate the Fireside Chat with the FDA, and Verification, Validation and Summative Human Factor Testing panels.