MODERATOR
:
SPEAKER
(S):
Alan E. Williams, PhD, Director, Division of Blood Application, Food and Drug Administration
How FDA Makes Blood Policy
Celso Bianco, MD, President, International Society of Blood Transfusion
A Blood Banker's View Of FDA's Policy Process
Dr. Jay Epstein, MD, Director, Office of Blood Research and Review, Food and Drug Administration
The Regulatory Philosophy on Policymaking
Description
The session will provide an opportunity for regulators and the blood banking community to share their perspectives on goals, guiding principles and legal constraints in the development of blood safety policies. The presentations and discussions will explore regulatory decision making on emerging threats to blood safety, pathways to development of new products and technologies, and the opportunities for the blood banking community to engage constructively in the regulatory process.
-
Determine how the FDA develops blood safety policies in the face of scientific uncertainties and in the absence of a standard for acceptance of risk.
-
Explain FDA's legal framework for regulatory decision making and its application in the context of blood product safety and availability.
-
Review the perspective of the blood banking community on ways to enhance its interactions with regulators.
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.