Session Information
AABB Annual Meeting and CTTXPO 2010
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Cord Blood Licensure
Track
:
QE- Quality Education
Program Code:
9111-QE-CT
Date:
Saturday, October 9, 2010
Time:
10:30 AM to 12:00 PM
EST
Location:
341/342
DIRECTOR
:
Ms. Fran Rabe, MS, CQM(ASQ), Director of Quality Assurance, University of Minnesota
MODERATOR
:
Ms. Fran Rabe, MS, CQM(ASQ), Director of Quality Assurance, University of Minnesota
SPEAKER
(S):
Ellen F. Lazarus, MD, CAPT, USPHS, Medical Officer, Food and Drug Adminstration
Janice Davis-Sproul, MAS, MT(ASCP)SBB, Manager, Cell Therapy Laboratory, Johns Hopkins Medicine
Description
Effective October 20, 2011 cord blood banks that distribute unrelated cord blood to patients within the U.S. are required to have an approved IND (Investigational New Drug Application) or BLA (Biologics License Application). The Food and Drug Administration (FDA) will present key features of the requirements of both the licensure and IND pathways. The FDA's presentation will be followed by scenarios intended to clarify critical applications to both pathways.
- Clarify and compare the licensure and IND pathways.
- Determine the mechanisms for distribution of domestic and international cord blood after October 20, 2011.
| 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: 9111-QE-CT)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
Non-Attendee/Non-Member $50 USD - Your Price
This session is a part of:
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