Omar Tounekti

Omar Tounekti

Company: Health Canada

Job title: Manager, Gene Therapies Division in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD)


Panel Discussion: Understanding The Nuances in Comparability Package Expectations at a Market Level 9:00 am

How are regulatory authorities aligning expectations to prevent market specific disparities in comparability criteria? What are the ‘need to know’ differences in comparability requirements globally that need to be considered? Why are the specifications for product release changing and how are the acceptance criteria for comparability tests deviating? Are there any leniencies provided for variable…Read more

day: Day One

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