QbD Roundtable

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.

Confirmed Speakers

• David Robbins, MedImmune

• Lynne Krummen, Genentech

• Kris Barnthouse, Johnson & Johnson, Janssen and Ranga Godavarti, Pfizer