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
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David Robbins, MedImmune
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Lynne Krummen, Genentech
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Kris Barnthouse, Johnson & Johnson, Janssen and Ranga Godavarti, Pfizer