Vaccines, Blood & Biologics
Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop
May 11 -12, 2010
8:00 a.m. – 5:30 p.m.
Workshop Goals and Objectives
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety.” The purpose of this workshop is to review the strategies used for identification, prioritization and response to emerging infectious diseases (EID) that are relevant to blood, cells, tissues and organs. The public workshop will feature presentations, case studies and round table discussions led by national and international experts from government, academia and industry. The workshop has been planned in partnership with the HHS Office of Science and Public Health, Centers for Disease Control and Prevention, National Institutes of Health and Health Resources Services Administration.
The characterization of risk from, and prioritization of response to, emerging infectious diseases relevant to blood, cells, tissue and organ safety has always been a complicated process. In terms of preparedness, when multiple EID agents threaten blood, cells, tissue and organ safety, it can be a challenge to prioritize efforts to address the resulting risk related issues since there is no single approach or formula that guarantees an ideal prioritization process. The public workshop will address processes for early threat detection and risk reduction of EID agents that are relevant to blood, cells, tissues and organs, including methods of “horizon scanning,” risk assessment, risk communication and application of emerging pathogen detection and pathogen reduction technologies. In addition, the workshop will discuss research needed to inform health policy decisions regarding screening and testing requirements for donors of human organs, cells and tissues for transplantation.
The first day of the workshop will focus on transfusion safety and include discussions on: 1) the identification, surveillance and prioritization of EID agents in the United States (U.S.) and internationally; 2) risk assessment methodologies; and 3) tools to address EIDs, including pathogen reduction technologies, microarray sequencing and prion detection capabilities. The second day of the workshop will address organ, cell and tissue transplantation safety. Topics for discussion include: 1) the regulatory frameworks for cells, tissue and organ transplantation; 2) approaches to the identification and evaluation of EIDs in the U.S. and internationally; 3) risk assessment methodologies; and 4) current research priorities, limitations and opportunities.
The Hilton Washington DC North Gaithersburg
620 Perry Parkway
Gaithersburg, MD 20877
There is no registration fee for the workshop. Early registration is recommended before April 30, 2010, as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: email@example.com Registrants will receive an e-mail confirmation.
Participants requiring overnight accommodations should contact the hotel directly and reference “EID” as the group code to receive the discounted group rate.
If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville, MD 20852
Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop Transcript - Day 1(PDF - 572KB) [ARCHIVED] Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop Transcript - Day 2(PDF - 496KB) [ARCHIVED]