(407c) Experiences with Quality by Design Filings and Prior Approval Inspections

Abstract:

Quality by Design has been embraced by the Pharmaceutical Industry yielding much progress in interpreting ICH Guidelines, implementing risk assessment strategies and constructing Design Space philosophies in an effort to improve scientific understanding during product development. These activities are then assessed at the time of dossier filing, when years of development work are evaluated for alignment with Health Authorities expectations.

This short presentation will introduce the audience to Novartis’ experiences regarding dossier module preparation and prior approval inspections conducted in the US and EU. Examples will be given highlighting the importance of source document quality and content and successful cross functional team interactions. The goal of this presentation is to provide enough detail to foster round table discussion and sharing of experiences regarding QbD filings.