Doctorate in Pharmacy, Pharmacology post-graduate, INSEAD, member of French Academy of Pharmacy 25 years in Pharmaceutical industry in Quality, Reg & QP Co-Chair of EFPIA Quality Ad Hoc Group. EFPIA Deputy Topic Leader in ICH Q10. EFPIA Topic Leader for ICH IWG Topics (Q8, Q9 & Q10)
VP, Head of Pharmaceutical Sciences Quality Assurance. Carol has Quality Assurance accountability for Pfizer’s global development and Clinical Trial Investigational Medicinal Product (IMP) portfolio. Carol received her honours undergraduate degree in chemical engineering in Dublin, Ireland.
He is the Head of External Relations Europe/Japan/CEMAI of Roche. He represents EFPIA on foreign inspections, ICH Q-IWG & on QRM. He received FDAs ‘Leveraging & Collaboration Award’ for developing a web-based knowledge base on QRM used for industry and regulatory. In PDA is chair of RAQAB & PCMO.
Description
This session will discuss knowledge management (KM) during and after QbD development. We will discuss key data to be considered, IT tools support, practical experience and debate about regulatory expectations.
Learning Objectives: Discuss the meaning of knowledge management during QbD development Discuss how industry with experience of QbD submission manage the knowledge Discuss the level of data which had to be considered in the Knowledge Management Illustration of IT tools to support knowledge management.