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 Heather Harwood, Director, Art & Communications, at

2016 CPS Presentations


Office of Combination Products - Strategic Priorities and Actions

Presenters: Thinh Nguyen and John Barr Weiner

Developing Successful Global Clinical Trials Strategies for your Product Approval

Presenters: Lori De Los Reyes

Cross-Labeling Challenges and Successful Practices

Presenters: Suzanne O’Shea and Rachel Turow

Digital Health

Presenters: Ray Silkaitis and Scott Thiel

Optimizing Your Inter-Center Combination Product Review

Presenter: Melissa Burns

Post-Market Safety Reporting Case Examples for Implementation

Presenter: Khaudeja Bano

Holistic Risk Profile Asessment

Presenters: Kara Carter and Marla Phillips

Inspection Readiness/Expectations

Presenters: Melissa Burns, Vijay Damodaran, Jianying (Julia) Ding, Susan Neadle, and John “Barr” Weiner