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.


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