Demystifying Quality by Design from an EU Regulator's Perspective
Jean-Louis Robert, CHMP/CVMP Quality Working Party
Implementation of ICH Q9 and Q10 in the EU
Jacques Morenas, ANSM (formerly Afssaps)
US Regulatory Perspective on the Implementation of QbD for Generic Drugs
Keith Webber, USFDA
The Quality by Design Paradigm and the Generics Industry
Pito Roslansky, Sandoz International GmbH.