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Session 7A: Leveraging Prior Knowledge During Lifecycle
Session Chair(s)
Sean Barry, PhD
Senior Pharmaceutical Assessor
Health Products Regulatory Authority (HPRA), Ireland
Prior Knowledge represents a relatively untapped resource, which can be used to support a broad range of regulatory submissions. This session will aim to explore a common understanding of Prior Knowledge and provide examples of where it can be used in support of new product applications and life cycle management.
Speaker(s)
Use of Prior Knowledge in the Development of Monoclonal Antibody
Kowid Ho, PharmD
F. Hoffmann-La Roche Ltd, Switzerland
Pharma Technical Regulatory Policy
Use of Prior Knowledge in Life Cycle of Vaccines
Nancy Cauwenberghs, PhD
MSD (Europe) Inc., Belgium
Senior Director Regulatory Affairs, Global Regulatory Affairs & Clinical Safety
How to Maximise the Effectiveness of Prior Knowledge in CMC Submissions
Sean Barry, PhD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
Panel Discussion
Peter Richardson, PhD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Panel Discussion
Ron Ogilvie
Pfizer, United Kingdom
CMC Advisor