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FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt
Manage episode 498986533 series 2945689
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This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kate Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. Spratt emphasizes the importance of early and continuous engagement with regulatory authorities, especially through structured meetings like INTERACT and pre-IND sessions. Harris and Spratt cover CMC readiness, filing for RMAT/CIT, BLA approvals and regulatory expectations, and more.
Subscribe to the podcast!
Apple | Spotify | YouTube
Visit my website: Cell & Gene
Connect with me on LinkedIn
112 episodes
Manage episode 498986533 series 2945689
We love to hear from our listeners. Send us a message.
This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kate Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. Spratt emphasizes the importance of early and continuous engagement with regulatory authorities, especially through structured meetings like INTERACT and pre-IND sessions. Harris and Spratt cover CMC readiness, filing for RMAT/CIT, BLA approvals and regulatory expectations, and more.
Subscribe to the podcast!
Apple | Spotify | YouTube
Visit my website: Cell & Gene
Connect with me on LinkedIn
112 episodes
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