Session Information
AABB Annual Meeting and CTTXPO 2010
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International Perspective on Regulatory Decisions
Track : QE- Quality Education
Program Code: 9124-QE
Date: Saturday, October 9, 2010
Time: 2:00 PM to 3:30 PM  EST
Location: 343/344
DIRECTOR :
Celso Bianco, MD, President, International Society of Blood Transfusion
MODERATOR :
Celso Bianco, MD, President, International Society of Blood Transfusion
SPEAKER (S):
Dr. Jay Epstein, MD, Director, Office of Blood Research and Review, Food and Drug Administration
The US Perspective
Peter Ganz, PhD, Director, Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada
The Canadian Perspective
Margarethe Heiden, PhD, Paul-Ehrlich-Institut
The German Perspective
Celso Bianco, MD, President, International Society of Blood Transfusion
Description
The session will provide an opportunity for regulators from the US, Canada, and Europe to share their perspectives on goals, guiding principles, and legal constraints in the development of blood safety policies. The presentations and discussions will explore different approaches to regulatory decision making on emerging threats to blood safety, pathways to development of new products and technologies, and the opportunities for international collaboration.

  • Determine how these regulators develop blood safety policies in the face of scientific uncertainties and in the absence of a standard for acceptance of risk.
  • Explain the regulatory framework for decision making in the context of blood safety and availability in the US, Canada and Europe.
  • Provide examples of difficult decisions confronted by the regulators.


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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