Navigating Special Regulatory Pathways For Advanced Therapy Development Success

How do you transform a promising advanced therapy into an approved medicine for patients? A critical step is effectively leveraging special regulatory pathways. In this webinar, join regulatory affairs and manufacturing experts as they discuss their strategies for engaging with the FDA and EMA. Hear directly from regulatory leaders about their experiences with the RMAT designation, from initial application to managing post-approval commitments.

The panel explores the value of a rolling BLA submission , the importance of early agency interaction , and how to align CMC and clinical development to meet regulatory expectations. Watch the full discussion to learn how to optimize your regulatory strategy.