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The Facts around FACT – Part 2

Debe Griffin, MSc, ASQ CPGP, has over 20 years of experience in the cell therapy field, both in bench positions and in leadership. Her primary interests are process improvement, quality assurance and regulatory affairs. She is a consultant with FACT Consulting...

Right Turn: Primers on cell therapy regulation

Understanding cell therapy regulation is an essential component of the bench to bedside pipeline. Without approval from a country’s regulator (Health Canada, FDA, EMA, PMDA, etc.), a product cannot be sold to consumers and the millions invested in research and...