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