Hayley Jackman

Company: AstraZeneca

Job title: Director, CMC Regulatory Affairs

Seminars:

Navigating Filing Scope for Targeted Radiotherapies & Engaging Authorities Under Evolving Guidance Standards to Fast-Track Submissions 4:30 pm

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…Read more

day: Conference Day One