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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
Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Use of Prior Knowledge in Life Cycle of Vaccines
Nancy Cauwenberghs, PhD
Head Global Labeling, GRA, J&J Innovative Medicines, Belgium
How to Maximise the Effectiveness of Prior Knowledge in CMC Submissions
Sean Barry, PhD
Senior Pharmaceutical Assessor , Health Products Regulatory Authority (HPRA), Ireland
Panel Discussion
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
Panel Discussion
Ron Ogilvie
CMC Advisor, Pfizer, United Kingdom