Valerie Ng
Associate Director- Regulatory Affairs CMC Kite Pharma Inc
Valerie Ng is Associate Director of Regulatory Affairs CMC at Kite Pharma, bringing over 10 years of experience across process development, manufacturing sciences, and regulatory strategy in biologics and cell therapy. Prior to Kite, she held key technical and process engineering roles at Genentech and Abbott, driving global process transfers and commercialization of advanced biologic products.
Seminars
Thursday 26th February 2026
Aligning Post-Approval Change Management Across FDA, EMA & PMDA
2:45 pm
- How ICHQ12 provides a shared foundation for post-approval change management
- Comparison of post-approval variations framework across the FDA, EMA and PMDA
- Adoption of risk-based CMC review models across the three agencies
