Accelerating QbD: Perspectives on Product Risk Assessments for Advanced Biologics

Perspectives on Product Risk Assessments for Advanced Biologics

A 60-minute cross-industry panel of experts will share their perspectives on conducting product risk assessments for biologics under a holistic, Quality-by-Design (QbD) framework.

Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of how to apply these principles as described in the ICH guidelines. The discussion will be based on real-world experiences and best practices that produce more complete and comprehensive submissions