Global Regulatory Update
Dr Christiane Niederlaender, Senior Quality Assessor, Biologicals, MHRA
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