Navigating Filing Scope for Targeted Radiotherapies & Engaging Authorities Under Evolving Guidance Standards to Fast-Track Submissions
Time: 4:30 pm
day: Conference Day One
Details:
- Clarify how to define the appropriate Module 3 scope when filing radiopharmaceuticals with multiple radionuclides, production routes, or variable target materials.
- Explore how to establish target purity profiles and target product profiles, and how these impact quality specifications, comparability, and filing complexity.
- Discuss best practices for early engagement with regulators (FDA, EMA, etc.) to align on isotope source qualification, dossier structure, and evolving quality standards.
