Keynote Sessions

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Keynote Presentations will cover:

EU Regulatory Perspective

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

US Regulatory Perspective on the Implementation of QbD for Generic Drugs
Keith Webber, USFDA

Industry Perspective

The Quality by Design Paradigm and the Generics Industry
Pito Roslansky, Sandoz International GmbH.