Session Information
AABB Annual Meeting and CTTXPO 2010
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International Regulations of Cell Therapy Products ISBT/AABB Joint Program
Track : QE- Quality Education
Program Code: 9233-QE-CT
Date: Sunday, October 10, 2010
Time: 4:00 PM to 5:30 PM  EST
Location: 345/346
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):
Paolo Rebulla, MD, Director, Center of Transfusion Medicine, Cellular Therapy and Cryobiology, Foundation Ospedale Maggiore Policlinico, Milano, Italy
European Cell Therapy Regulations
Deirdre Fehily, PhD, Inspector and Technical Advisor - Tissues and Cells, Centro Nazionale Trapianti
Harmonizing the Regulation of Tissues and Cells in the European Union
Kathy Loper, MHS, MT(ASCP), Director of Cellular Therapies, AABB
AHCTA Update
Ellen F. Lazarus, MD, CAPT, USPHS, Medical Officer, Food and Drug Adminstration
Description
Cellular Products for therapeutic benefit have been used clinically for over 30 years. Recently, many regulatory bodies from multiple countries have published minimum requirements that cell therapy facilities must follow. These standards apply to both the facilities and the products that they issue. As an increasing number of cellular products are being distributed across borders, it is important for everyone to know which regulations (both voluntary and mandatory) are in place where the cellular product was recovered, processed and released for clinical utility. This session will provide an overview of worldwide governmental regulations that apply to cellular products. In addition, there will be an update on the activities of the Alliance for Harmonization of Cellular Therapy (ACHTA) whose mission is to identify potential areas of standards that can be harmonized between organizations and between countries.

LEARNER OUTCOMES:
  • Describe the European Cell Therapy Regulations and how they may differ from country specific requirements.
  • Discuss the current (and future) regulation of importation of unrelated cellular products into the US.
  • Provide a progress report on the efforts of AHCTA and its role in the Worldwide Network for Blood and Marrow Transplantation (WBMT).
  • Review the US regulations concerning cellular products including Cord Blood Licensure.


CE CategoryCE 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.
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