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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Quantitative Risk Assessment: Blood Safety and Availability Public Workshop

May 13, 2010
8:30 a.m. – 5:00 p.m.

Workshop Goals and Objectives

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Quantitative Risk Assessment: Blood Safety and Availability.” The purpose of this workshop is to review the scientific principles of risk assessment and to discuss the role of risk assessment in the regulatory process, specifically as it relates to blood safety and availability.

FDA’s mission to protect public health is a complex challenge that frequently requires regulators to use sophisticated analyses of risk and benefit to reach informed decisions concerning the safety and effectiveness of therapeutics. To reach optimal decisions, regulators will often use a risk analysis that involves a deliberative process of risk management, risk communication and risk assessment. The workshop aims to increase the transparency of the decision-making process at FDA by increasing public understanding of risk assessment in the regulatory process for blood products.

Risk assessment is a process that reflects a structured approach of hazard identification, hazard characterization, exposure assessment and risk characterization. The QRA public workshop is designed to enhance understanding of the agency’s operations and decision-making process in this regard. The workshop will discuss the principles of risk assessment and a detailed case study using a recent risk assessment related to blood safety and availability will be presented.

Location

The Hilton Washington DC North Gaithersburg
620 Perry Parkway
Gaithersburg, MD 20877

Registration

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 Mark O. Walderhaug, Ph.D., Center for Biologics Evaluation and Research (HFM-210), Food and Drug Administration, Suite 400S, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-0648; E-mail: mark.walderhaug@fda.hhs.gov.

Contact Person

Mark Walderhaug, Ph.D.
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-210
Rockville, MD 20852
Phone: 301-827-6028
Fax: 301-827-0648
e-mail: mark.walderhaug@fda.hhs.gov