Learning Tracks

This session will provide an understanding of current data and outcomes related to device requirements for biosimilars and interchangeable biosimilars and how this might shape future guidances. This session also will provide information on:
• BSUFA research roadmap data that support understanding of user interface differences that will likely lead to differences in use error rates or use success rates
• Alternative approaches to Comparative Use Human Factors Studies for those differences that pose no or low risk of error rates and future guidance
• An overview of FDA’s perspective on interchangeable biosimilars and devices.

Moderator: Maria Burkholder, MHA
Senior Director, Regulatory Affairs Global Biosimilars, Teva Pharmaceuticals

Cris Ausin, PhD
Scientific Reviewer, OTBB, OND, CDER, Food and Drug Administration

Amith Belavadi 
Director, Technical Program Management, Project & Portfolio Management, Amneal Pharmaceuticals

Jason Flint, MBA, PMP
Deputy Director, Division of Medication Error Prevention and Analysis I (DMEPA), OSE, CDER, Food and Drug Administration

Johannes Keuschnigg, PhD
Regulatory Devices Portfolio Head, Sandoz