January 28, 2014
8:30 a.m. to 5:00 p.m.
January 29, 2014
8:30 a.m. to 12:00 p.m.
Workshop Goals and Objectives:
The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Strategies to Address Hemolytic Complications of Immune Globulin Infusions.” The goals of the workshop are to identify and discuss potential risk mitigation strategies for IG-associated hemolysis, including improved identification of patients at high risk for hemolysis; changes in product specifications, tests, or test methods; and modifications to manufacturing to lower product risk. In addition, this workshop is intended to identify and discuss important outstanding research questions related to patient risk and product characteristics.
The first day of this workshop will include presentations and panel discussions on the following topics: (1) pathogenesis and epidemiology of IGIV-associated hemolysis, (2) patient risk factors, and (3) possible product risk factors, including the presence of Anti-A and Anti-B hemagglutinins. The second day of the workshop will include presentations and panel discussions on the following topics: (1) immune globulin manufacturing and risk mitigation strategies, and (2) workshop summary and conclusions.
The workshop has been planned in partnership with the National Heart, Lung and Blood Institute, National Institutes of Health and the Plasma Protein Therapeutics Association. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.
Lister Hill Center Auditorium
National Institutes of Health Campus
8600 Rockville Pike
Bethesda, MD 20894
Email or fax the registration form with the following information (name, title, firm name, address, telephone, and fax numbers) to Chris Nguyen (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (Subject line: IG Hemolysis Workshop Registration) by January 10, 2014.
There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m. Pre-registered participants will receive additional information on security procedures, parking, and public transportation with their email registration confirmation.
Center for Biologics Evaluation and Research (HFM-49)
Food and Drug Administration
1401 Rockville Pike, suite 200N
Rockville, MD 20852-1448
Email: CBERPublicEvents@fda.hhs.gov (Subject line: IG Hemolysis Workshop)