Webinar: Issues in Product Characterization

CIRM/Regenerative Medicine Consortium Webinar

Characterization and Its Critical Role in Manufacturing – Better, Faster and Cost Effective Approaches for the Stem Cell and Regenerative Medicine Industry

Presented by RMC, FDA and Industry Leaders

Fee: None

Webinar Topic & Agenda

Key Issues in Product Characterization

• Regulatory requirements
• Importance as a foundation in manufacturing process development
• Designing a cost effective program
• Lessons learned

Moderator: Elona Baum, General Counsel, CIRM and RMC Chair

Speakers

• Mahendra Rao, Ph.D., Life Technologies, Vice President of Stem Cell Research
• Scott R. Burger, M.D., Advanced Cell and Gene Therapy
• Donald W. Fink, Jr., Ph.D., Cell Therapy Branch, Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and
• Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Questions/Logistics:
Cynthia Schaffer
415.396.9241
cschaffer@cirm.ca.gov