Global Regulatory Update
The past few years have witnessed an unprecedented increase in the range of expedited regulatory pathways potentially available to cell & gene therapy developers across the world. From RMAT to PRIME, and from Breakthrough Designation to the PMD Act, a weight of experience and insight now exists to help you capitalize on the benefits whilst avoiding the pitfalls.
- Strategic pros/cons and practical considerations with accelerated development and conditional approval pathways
- Keys to remaining nimble and flexible with clinical trial designs and parallel product/process development
- Step-by-step guides to making successful pathway applications