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Information For:
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2005 – 2010 Biologics & Biotechnology – Cell, Gene, and Tissue Therapies Expert CommitteeTissues and Tissue-Based Products Workshop
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| 8:00 a.m. | Continental Breakfast | |
| 8:30 a.m. | 1. Welcome | Dr. Williams |
| 2. USP Role in Development of Standards for Drugs and Biologics | ||
| a. USP Standards and Value of Public Standards | Dr. Abernethy |
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| b. Biological Products – Vertical vs. Horizontal Standards | Dr. Morris |
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| c. Cell and Tissue Therapies Standards at USP | Mr. Tente |
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| 10:00 a.m. | Break | |
| 3. Regulatory Challenges for Tissue-products | ||
| a. U.S. Food and Drug Administration Regulation of for Human Cells, Tissues and Tissues-Based Products | Dr. Witten |
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| b. Use of Standards in Tissue–Based Products Regulated as Devices | Dr. Kaplan |
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| 11:15 a.m. | 4. USP requirements for Tissue–products Standards | |
| a. Monograph Requirements for Tissue-based products | Dr. Atouf |
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| 12:00 noon | Lunch | |
| 1:00 p.m. | 5. Roles for Stakeholder Organizations to Facilitate Development of Scientifically Useful Standards for Development of Tissue Monographs | |
| a. AATB Perspective | Mr. Brubaker |
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| b. ASTM Perspective | Dr. Cahn |
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| c. Industry Perspective | ||
| i. Integra | Ms. O'Grady |
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| ii. Wright Medical Technology | Drs. Burgess/Blum | |
| iii. Cryolife | Mr. Neja |
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| 2:30 p.m. | 6. Ensuring Quality and Development of Standards for Tissue Products | |
| a. Microbiology and Sterility Assurance | Dr. Sutton |
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| b. Classification and Nomenclature | Dr. Weber |
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| c. Challenges and Opportunities for Standards development for Tissue – Based Products | Dr. Atouf |
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| 4:00 p.m. | 6. Discussions and Wrap–up | |
| 4:30 p.m. | Adjourn | |