This roundtable will consist of several 15-20 min short talks describing recent regulatory experiences with QbD filings. Afterwards, panelists will lead a discussion on current and future regulatory strategies for implementing QbD. Session chairs to strive to set up open, frank and constructive environment with panelists.
David Robbins, MedImmune
Lynne Krummen, Genentech
Kris Barnthouse, Johnson & Johnson, Janssen and Ranga Godavarti, Pfizer