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Session 6C: Comparability Biologicals
Session Chair(s)
Anthony Ridgway, PHD
Acting Director, Biologics and Genetic Therapies Directorate, Health Canada, Canada
Speaker(s)
Anthony S Lubiniecki
Senior Scientific Director & Fellow, Janssen R&D LLC, United States
An Industrial View of Comparability Applied to Biopharmaceuticals
Linan Ha
Team Leader, Division of Biotechnology Review & Research I, OBP, OPQ, CDER, FDA, United States
FDA Perspective
Kowid Ho, PHARMD
Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
European Perspective