Aligning mRNA Quality & CMC Strategies with Evolving European Regulatory Expectations
- Interpret how draft mRNA guidelines and ATMP frameworks are shaping regulator expectations for quality, control strategies, and CMC robustness
- Understand how quality considerations are evolving as mRNA applications diversify across indications, modalities, and delivery approaches
- Learn how early scientific advice and engagement with authorities can be used to strengthen CMC packages and de-risk development pathways