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Overview of Quantitative Risk Assessment Process and Data Needs.ppt

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					Overview of Quantitative
Risk Assessment Process
     and Data Needs

     Mark Walderhaug,
     FDA/CBER/OBE
Quantitative Risk Assessment
l   Elements of a risk assessment
    • Hazard Identification
    • Hazard Characterization
    • Exposure Assessment
    • Risk Characterization
Hazard Identification
l   Sometimes simple
    • What is the risk of transfusion-transmitted
      disease of a specific emerging arbovirus with
      a significant asymptomatic post infection
      period?
l   Sometimes not simple
    • XMRV
Hazard Characterization
l   Also called Dose-Response
l   Difficult to get information
l   How many Malaria or Babesia
    sporozoites will cause disease in a blood
    recipient?
l   What does the dose-response curve look
    like?
Exposure Assessment
l   Blood is generally not pooled, but
    components sometimes are
l   Amounts from billing information
l   Variable amounts of blood products
    received
l   Using individual data to build a public
    health model
Risk Characterization
l   The integration of Hazard
    Characterization and Exposure
    Assessment
l   Generally carries a lot of information, but
    must be comprehensible
l   It’s challenging.
Benefit Characterization?
l   Efficacy of blood – critical in many cases
l   Blood supply
    • Reserve – capacity to withstand shocks
    • Replacing lost donors: Safety of new donors
      compared to safety of established donors
Hypothetical Epidemic Curve for
TTI
Current Time to completion
l   vCJD risk assessment
    •   Months over multiple years
l   Malaria risk assessment
    •   Months over two years
l   Babesiosis risk assessment
    •   Months but ongoing
l   The next Emerging TTI
    •   ?
This Workshop
l   It’s about risk assessment
l   Decision-makers need the best quality
    information as rapidly as possible
l   The impact of risk assessment on risk
    management
l   Stakeholders have the key to the needed
    data
l   How do we work together better?

				
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posted:1/27/2014
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