12:00pm Navigating Regulatory Challenges to Address ADC CMC Change Hurdles for BLA/NDA Approval
Time: 12:00 pm
day: Day One CMC Track
Details:
- Gaining insights into regulatory frameworks and strategies for submission timelines to support efficient manufacturing during the clinical phase and preparation for BLA/NDA submission
- Setting comparability study acceptance criteria for site transfer and scale-up during clinical phase
- Leveraging CMC lessons learned from global case studies to adapt to regulatory compliance for setting product release specifications and process validations
