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Navigating the Challenges of Drug Delivery Using a Novel Device
Session Chair(s)
John Lockwood
Sr. Director
Cencora Pharmalex, United States
Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.
Learning Objective : Analyze the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.
Speaker(s)
Regulatory Considerations for the Next Generation of Drug Delivery Devices
Yoshiko Stowell, PhD, MS, PMP, RAC
Kenai Therapeutics, United States
Vice President Regulatory Affairs
Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC
AbbVie, United States
Associate Director, RA Device and Combination Products
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