Webinar: Issues in Product Characterization

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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 Overview

CIRM will host this webinar as the sponsor of the Regenerative Medicine Consortium’s (RMC’s) webinar series on IND readiness. The mission of the RMC is to accelerate the development and regulatory approval of stem cell and regenerative medicine therapies. For more information please see
/our-funding/regenerative-medicine-consortium.

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

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