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Advanced Therapies: Innovations in CMC Conference

Solutions for CMC challenges in the development and commercialization of cell therapy, gene therapy, and gene editing products.

Agenda

Day 1 Jan 01, 0001

12:00 AM — 12:00 AM

Day 2 Nov 08, 2021

10:00 AM — 11:00 AM Opening Remarks and Keynote Address
11:00 AM — 11:15 AM Break
11:15 AM — 12:15 PM Session 1: Regulatory Framework and GMP Requirements for ATMPs
12:15 PM — 12:30 PM Break
12:30 PM — 1:45 PM Session 2: Bridging the Gap for CMC Assessments Comparability Through Risk-based Control Strategies – Part 1
1:45 PM — 2:15 PM Break
2:15 PM — 3:30 PM Session 3: Bridging the Gap for CMC Assessments Comparability Through Risk-based Control Strategies – Part 2

Day 3 Nov 09, 2021

10:00 AM — 11:30 AM Session 4: Starting and Raw Materials in Cell and Gene Therapy
11:30 AM — 11:45 AM Break
11:45 AM — 12:45 PM Session 5a: Case Studies in Gene Therapy Development
12:45 PM — 1:15 PM Break
1:15 PM — 2:15 PM Session 5b: Case Studies on Challenges for Gene Editing Technology
2:15 PM — 2:45 PM Break
2:45 PM — 3:45 PM Session 5c: Case Studies on Challenges for Cell-based Therapeutics

Day 4 Nov 10, 2021

10:00 AM — 11:00 AM Session 6: Utilizing FDA’s Emerging Technology Teams and EMA’s Regulatory Support Tools During Product Development
11:00 AM — 11:15 AM Break
11:15 AM — 12:30 PM Session 7: Lessons Learned From Development of Vaccines and Therapeutics in Response to COVID-19
12:30 PM — 1:00 PM Break
1:00 PM — 2:30 PM Session 8: Fireside Chat: Regulatory Approaches to Emerging Technologies and Modalities Closing Remarks
2:30 PM — 2:30 PM Conference Adjourns

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