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Immunogenicity Assessment – Risk-Based Approaches
Session Chair(s)
Markku Toivonen, MD, PHD
NDA Group, United Kingdom
Immunogenicity data prior to approval are generally limited and further systematic testing is usually required. Risk-based approaches to immunogenicity assessment in the pre- and post-authorisation phases informs necessary risk minimisation strategies and selection of optimal data collection and analysis methods for the completion of missing information.
Speaker(s)
Risk-Based Approach to Immunogenicity Assessment
Paul Chamberlain
NDA Advisory Board, United Kingdom
Biopharmaceuticals & Immunogenicity Expert
Generating Data that Matter for Post-Authorisation Evaluation of Immunogenicity
Gertjan Wolbink
Sanquin, Netherlands
Researcher Immunopathology
Immunogenicity from the Risk Minimisation Perspective
Thijs Giezen, PHARMD, PHD, MSC
Medicines Evaluation Board, Netherlands