Kate Bassett

Company: AstraZeneca

Job title: Head of International CMC Regulatory Affairs

Seminars:

Evolving CMC Expectations for Cell & Gene Therapies: From Initial Filing to Post-Approval Change 10:00 am

Highlighting Health Canada’s approach to comparability and post-approval manufacturing changes Addressing the challenges of scaling CMC data from early-phase to BLA for complex gene therapy platforms Sharing insights on dossier readiness, common deficiencies, and opportunities for regulatory efficiencyRead more

day: Conference Day Two