Session Information
AABB Annual Meeting and TXPO 2009
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Cord Blood Licensure, Part I
Track
:
QE- Quality/Education
Program Code:
9204-QE-CT
Date:
Sunday, October 25, 2009
Time:
8:30 AM to 10:00 AM
EST
Location:
292
DIRECTOR
:
John D. McMannis, Ph.D., Director, Cell Therapy Laboratory, The University of Texas MD Anderson Cancer Center
MODERATOR
:
John D. McMannis, Ph.D., Director, Cell Therapy Laboratory, The University of Texas MD Anderson Cancer Center
SPEAKER
(S):
Mary Beth Fisk, MT, CTBS, CQA, Executive Vice President, South Texas Blood & Tissue Center
Ellen F. Lazarus, MD, CAPT, USPHS, Medical Officer, Food and Drug Adminstration
Liana Harvath, PhD, Consultant, Liana Harvath, PhD, LLC
Description
A draft guidance document to assist public cord blood banks obtain a biologic license has been published by the FDA, with issuance of the final guidance expected shortly. The publication outlines a mechanism that facilities can use to apply for a cord blood license. AABB plans to hold a workshop in Bethesda, MD to inform facilities on what is required to submit a BLA once the Final Guidance is published. This session will provide some of the background of how far the CB regulations have progressed and what CBB can do today to prepare for publication of the Final Document.
- Discuss the history and regulatory challenges for public Cord Blood Banks planning to submit a Biologics License Application (BLA) to FDA .
- Identify the steps that cord blood banks currently need to follow in order to obtain licensure and compare to those in the draft Cord Blood Guidance.
- Outline a program approach for applying an industry acceptable quality plan.
| 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: 9204MA/9204NA/9204MN/9204NN)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
$50 USD - Your Price
This session is a part of:
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