Licensure of
Apheresis Blood Products
August 15, 2007
Lister Hill Auditorium, NIH
Bethesda, MD
CBER’s Vision
Protect and improve public and individual health
in the United States and, where feasible,
globally;
Facilitate the development, approval of, and
access to safe and effective products and
promising new technologies; and
Strengthen CBER as a preeminent regulatory
organization for biologics.
Licensure of
Apheresis Blood Products Workshop
The purpose of this public workshop is to
educate industry on the licensure requirements
and license application procedures for Platelets,
Pheresis, Red Blood Cells, and Plasma
collected by automated cell separator devices.
Licensure of
Apheresis Blood Products
Workshop Co-Sponsors
• Center for Biologics Evaluation and
Research, FDA
• HHS Office of the Secretary/Office of
Public Health and Science
• AABB
• America’s Blood Centers (ABC)
Agenda
Welcoming Remarks, Jesse Goodman, M.D.,
M.P.H., FDA
The Regulatory Paradigm and Managed
Review, Alan E. Williams, Ph.D., FDA
FDA Review of Apheresis Submissions, Judy
Ellen Ciaraldi, MT (ASCP)SBB, CQA (ASQ),
FDA
Top Ten Pitfalls with Submissions, Rosia E.
Nesbitt, B.S. (ASCP) SBB, CQA (ASQ), FDA
Agenda
Examples of Successful Submissions
Preparing Apheresis License Submissions
Stephen Kassapian, American Red Cross
Blood Systems’ Licensure of 5 and 7-Day
Platelets, Kathleen Hopping, B.S., CQA (ASQ),
Blood Systems, Inc.
FDA Guidance on Collection of Platelets by
Automated Methods, Lore Fields, MT (ASCP)
SBB, FDA
Agenda
Impact of Very Frequent Plateletpheresis
on Donor Platelet Counts, Louis M. Katz,
M.D., Mississippi Valley Regional Blood
Center
Agenda
Failure Investigations of Apheresis Blood Products
FDA Regulations and Recommendations for
Failure Investigations, Hoi-may Wong, B.S., MT
(ASCP) SBB, FDA
Experiences with a Failure Investigation
Program for Apheresis Blood Products, Faye
Kugele, M.S., MT (ASCP) SBB, CQM (ASQ),
American Red Cross
Agenda
Meet Your FDA Consumer Safety Officer
Agenda
Device Manufacturer’s Forum
Merilyn Wiler, MT (ASCP) SBB, Gambro BCT
Sharyn Orton, Ph.D., Fenwal
Sue Finneran, Haemonetics
Frequently Asked Questions and Answers, Panel
of FDA staff
Licensure of
Apheresis Blood Products
Workshop
Workshop Planning Committee:
Celso Bianco, M.D., ABC
Sue Finneran, Haemonetics
Joe Giglio, M.S., MT(ASCP)SBB, AABB
Steve Kassapian, ARC
Sharyn Orton, Ph.D., Fenwal, Inc
Merilyn Wiler, MT(ASCP)SBB, Gambro BCT
Workshop Planning Committee:
• Alan Williams, Ph.D., Associate Director,
Regulatory Affairs
• Elizabeth Callaghan, Acting Director, Division of
Blood Applications
• Jennifer Scharpf, OBRR Associate Director for
Policy
• Rhonda Dawson, Policy Analyst
• Lore Fields MT(ASCP)SBB, Consumer Safety
Officer, Blood and Plasma Branch
• Rosia Nesbitt MT(ASCP)SBB, Consumer Safety
Officer, Blood and Plasma Branch
• Hoi-May Wong MT(ASCP), Consumer Safety
Officer, Blood and Plasma Branch