Presentations

For your convenience, the Xavier Combination Products Summit presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Stacie Ball, Program Manager, at 513-745-3483 or balls2@xavier.edu. Archived Presentations:  To access past Combination Products Summit Presentations, visit our archives page. Below are the 2016 Combination Products Summit Presentations.
Speakers Session Title Presentation
Thinh Nguyen and John "Barr" Weiner Office of Combination Products - Strategic Priorities and Actions
Lori De Los Reyes Developing Successful Global Clinical Trials Strategies for your Product Approval
Suzanne O’Shea and Rachel Turow Cross-Labeling Challenges and Successful Practices
Ray Silkaitis and Scott Thiel Digital Health
Melissa Burns Optimizing Your Inter-Center Combination Product Review
Khaudeja Bano Post-Market Safety Reporting Case Examples for Implementation
Kara Carter and Marla Phillips Holistic Risk Profile Asessment
Melissa Burns, Vijay Damodaran, Jianying (Julia) Ding, Susan Neadle, and John “Barr” Weiner Inspection Readiness/Expectations
Chelsea O'Connell, Thinh Nguyen, Suzette Roan, John "Barr" Weiner Industry Successful Practices for Navigating Post-Market Changes