This session will describe the scope of the EMA-FDA Parallel Assessment Pilot for applications containing Quality-by-Design Information. The purpose of this pilot, initiated in March 2011, is to help ensure consistent implementation of ICH quality guidelines and to harmonize regulatory decisions to the greatest extent possible. The progress on EMA-FDA parallel assessment to date and perceived challenges will be addressed.

Learning Objectives:
Discuss the scope and objectives of the EMA-FDA Parallel Assessment Pilot for Quality by Design containing applications
Describe the progress on EMA-FDA parallel assessment and perceived challenges.