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Vaccines, Blood & Biologics

Public Workshop - Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products

November 29, 2011

8:30 a.m. – 5:00 p.m.

Workshop Goals and Objectives

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products.” The purpose of the public workshop is to discuss data and data sources currently used by FDA, possible new sources of data, and development of new studies and information through collaboration with stakeholders. The public workshop will include presentations and panel discussions with experts from stakeholders, academia, regulated industry, and government.

Quantitative risk assessments (QRAs) are an important tool for evaluating the risks associated with new emerging infectious diseases (EIDs) that are relevant to blood and blood products and the benefits of mitigation options. QRAs make it possible for decision-makers to develop policy for blood and blood product safety and availability using sound science and the best data and information available.

Rapid data collection, information sharing, and analyses estimating the magnitude and probability of risk can be expedited by proactively building and maintaining critical relationships both within the Center for Biologics Evaluation and Research (CBER) and with external stakeholders. In this public workshop, CBER is seeking access to accurate, reliable data on factors such as disease prevalence, incubation periods, behavioral risks associated with disease transmission, potential donor exposure risks, and susceptibility to EIDs, product handling, usage, and others.

Lack of data and information are major challenges FDA faces when there is a new EID. The public workshop will: 1) provide a forum for discussion of data used in conducting quantitative risk assessments for EIDs; 2) address approaches to facilitate the timely access to data required to evaluate public health measures designed to reduce the potential risk associated with EIDs that are relevant to blood and blood products; and 3) provide a forum for discussion of the development of new data sources and enhanced access to already exiting data sources.

Location

Gaithersburg Hilton
620 Perry Parkway
Gaithersburg, MD 20877

Please visit the Gaithersburg Hilton website for directions and visitor parkingdisclaimer icon. By public transportation (including bicycle) the Montgomery County, MD Ride On bus 54disclaimer icon goes from Rockville to 620 Perry Parkway in Gaithersburg.

Registration

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 8 a.m. To register, complete the attached registration form in this announcement and mail, fax or email it to Lou Gallagher, Food and Drug Administration, HFM-210, 1401 Rockville Pike, Rockville, MD 20852: Fax: 301 827 3529; E-mail: lou.gallagher@fda.hhs.gov

If you need special accommodations due to a disability, please contact Lou Gallagher at least 7 days in advance of the workshop.

For Program Information Contact

Lou Gallagher
Senior Staff Fellow
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Biostatistics and Epidemiology
1401 Rockville Pike, HFM-210
Rockville, MD 20852-1448
Phone: 301-827-5988
Fax: 301-827-3529
email: lou.gallagher@fda.hhs.gov

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