Cancer Vaccines: What Will It Take to Get Across the Regulatory Finish Line?
Time: 4:30 pm
day: Conference Day Two
Details:
• How to map high-risk regulatory friction points across QC, automation, patient consent and biopsy logistics
• How to document control strategies and decision rationales that hold up under agency scrutiny
• How to engage regulators on batch-specific vs platform-level controls, and when to request Type C/scientific advice meetings
