Session Information
AABB Annual Meeting and TXPO 2009
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FDA Regulations for Cellular Therapy Products: What Applies Now
Track
:
QE- Quality/Education
Program Code:
9109-QE-CT
Date:
Saturday, October 24, 2009
Time:
10:30 AM to 12:00 PM
EST
Location:
296
DIRECTOR
:
Janice Davis-Sproul, MAS, MT(ASCP)SBB, Manager, Cell Therapy Laboratory, Johns Hopkins Medicine
MODERATOR
:
Janice Davis-Sproul, MAS, MT(ASCP)SBB, Manager, Cell Therapy Laboratory, Johns Hopkins Medicine
SPEAKER
:
Ellen F. Lazarus, MD, CAPT, USPHS, Medical Officer, Food and Drug Adminstration
Description
The FDA uses a risk-based approach for the regulation of human cells and tissues. This means that the regulations can be applied to a wide variety of products and that the type of regulation is commensurate with the risk posed by the product. This approach has yielded two categories of cell and tissue-based products, often referred to as 351 and 361 products.
This session will use lectures and case studies to review and interpret FDA regulations for Cellular and Tissue-Based Products. The focus will be on understanding the framework of product classification in order to determine which products require an IND/IDE and which do not.
This session will use lectures and case studies to review and interpret FDA regulations for Cellular and Tissue-Based Products. The focus will be on understanding the framework of product classification in order to determine which products require an IND/IDE and which do not.
- Apply the regulations to determine if a product is a '351' (GMP) product or a '361' (GTP) product.
- Discuss the impact of 2008/2009 FDA Cellular Therapy Product guidances on the processing laboratory.
- Review FDA regulations for biological products that contain cells and/or tissue.
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.8 |
| Florida Laboratory Personnel | 1.8 |
| General Attendee | 1.5 |
| Physician | 1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
This session is a part of:
Online Access
(Code: 9109MA/9109NA/9109MN/9109NN)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
$50 USD - Your Price
This session is a part of:
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