Evolving CMC Expectations for Cell & Gene Therapies: From Initial Filing to Post-Approval Change
Time: 10:00 am
day: Conference Day Two
Details:
- 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 efficiency
