1. Licensure of Apheresis Blood Products August 15, 2007 Lister Hill Auditorium, NIH Bethesda, MD

2. 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.

3. 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.

4. 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)

5. 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

6. 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

7. Agenda Impact of Very Frequent Plateletpheresis on Donor Platelet Counts, Louis M. Katz, M.D., Mississippi Valley Regional Blood Center

8. 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

9. Agenda Meet Your FDA Consumer Safety Officer

10. 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

11. 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

12. 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