Regulatory Congress for Cell & Gene-Based Therapy
November 14 - 15, 2018 - Arlington MA USCBI
jkuchinski@cbinet.com
Phone:+1-339-298-2112
Mapping Pre-Clinical and Clinical Timelines to CMC and CMC Regulatory Strategies Cell and gene therapies often address unmet needs for incurable and fatal disease. As a result, there’s a strong push for regulators to expedite applications, and with that speed comes questions, and risk, for biotheraputic manufacturers. CBI’s Regulatory Congress for Cell & Gene-Based Therapy focuses on examining and mapping expedited regulatory pathways for next generation therapeutics. Join your peers and colleagues to learn how to expedite regulatory approval without compromising CMC integrity. • A Dialogue-Driven Forum on Existing Regulatory Pathways and Draft Guidances • Understand the Linkages Between CMC and Pre-Clinical Work • Learn To Quickly Scale Up CMC Operations Without Compromising Regulatory Success • Learn to Select Alternative Endpoints for Clinical Trial Success • Learn to Manage Unique Post-Approval Commitments for Cell and Gene-Based Therapies • Benchmark Expedited Pathway Strategies for Accelerated Approval