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U.S. Food and Drug Administration

U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. Overview of Quantitative Risk Assessment Process and Data Needs.

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U.S. Food and Drug Administration

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  1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

  2. Overview of Quantitative Risk Assessment Process and Data Needs Mark Walderhaug, FDA/CBER/OBE

  3. Quantitative Risk Assessment • Elements of a risk assessment • Hazard Identification • Hazard Characterization • Exposure Assessment • Risk Characterization

  4. Hazard Identification • Sometimes simple • What is the risk of transfusion-transmitted disease of a specific emerging arbovirus with a significant asymptomatic post infection period? • Sometimes not simple • XMRV

  5. Hazard Characterization • Also called Dose-Response • Difficult to get information • How many Malaria or Babesia sporozoites will cause disease in a blood recipient? • What does the dose-response curve look like?

  6. Exposure Assessment • Blood is generally not pooled, but components sometimes are • Amounts from billing information • Variable amounts of blood products received • Using individual data to build a public health model

  7. Risk Characterization • The integration of Hazard Characterization and Exposure Assessment • Generally carries a lot of information, but must be comprehensible • It’s challenging.

  8. Benefit Characterization? • Efficacy of blood – critical in many cases • Blood supply • Reserve – capacity to withstand shocks • Replacing lost donors: Safety of new donors compared to safety of established donors

  9. Hypothetical Epidemic Curve for TTI

  10. Current Time to completion • vCJD risk assessment • Months over multiple years • Malaria risk assessment • Months over two years • Babesiosis risk assessment • Months but ongoing • The next Emerging TTI • ?

  11. This Workshop • It’s about risk assessment • Decision-makers need the best quality information as rapidly as possible • The impact of risk assessment on risk management • Stakeholders have the key to the needed data • How do we work together better?

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