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Post-Approval Monitoring: What does a program look like?

Post-Approval Monitoring: What does a program look like?. Elaine N Joseph, PhD Regulatory Compliance Manager University of Michigan. Today’s Outline. Why should we (and our PIs) care? The many faces of “PAM” How to make PAM more Efficient Assessment of Effectiveness Conclusions.

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Post-Approval Monitoring: What does a program look like?

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  1. Post-Approval Monitoring: What does a program look like? Elaine N Joseph, PhD Regulatory Compliance Manager University of Michigan

  2. Today’s Outline • Why should we (and our PIs) care? • The many faces of “PAM” • How to make PAM more Efficient • Assessment of Effectiveness • Conclusions

  3. What is a PAM Program Anyway? • Formalized review of protocols by regulatory compliance staff • Detailed annual review of all protocols • Observation of surgical procedures by veterinary or compliance staff • Regular review of adverse events and unexpected outcomes • Inspections of laboratory spaces, surgical records, etc.

  4. Basic Structure UM PAM • Every investigator, every protocol, every year • Review of approved protocol(s) • Review of new/changed policies/guidelines • Review of personnel training reports • Review of records (e.g., surgical)

  5. Format of a PAM • Open-ended questions “Tell me about the surgeries you perform on this protocol.” “What kind of anesthetics do you use?” • Probing questions “How, exactly, do you prepare the animal for surgery?” • Open and non-confrontational atmosphere

  6. How to Make PAM do More with Less • Educate PIs • New and revised policies/guidelines • How to navigate online protocol system • Inspect Controlled Drug Storage/Use Logs • Inspect laboratory euthanasia stations/rodent surgery stations • Assess procedural competency by observing surgical/technical procedures

  7. How to Make PAM do More with Less • Gather/verify data for annual (e.g., USDA) census • Check laboratory training logs/data • Cross-verify compliance with IBC/Biosafety • Conduct the Annual Review (for USDA protocols)

  8. How do we Know PAM is Effective? • Increase number of protocol amendments • Decrease in number of serious/continuing non-compliance • Foster a cooperative and collegial relationship between the IACUC and investigators!

  9. Any Questions?

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