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Content provided by Erin Harris. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Erin Harris or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt

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Manage episode 498986533 series 2945689
Content provided by Erin Harris. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Erin Harris or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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

  continue reading

112 episodes

Artwork
iconShare
 
Manage episode 498986533 series 2945689
Content provided by Erin Harris. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Erin Harris or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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

  continue reading

112 episodes

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