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Monday, Nov 18th
1:45 PM – 3:00 PM PTB08 - Empowering the Participant Voice: Using Research Participant Experience Data to Address Research Disparities and Enhance QualityLocation: Room 332
Speaker: – The Rockefeller University
Speaker: – University of California, Santa Cruz
QA/QI and Postapproval MonitoringAdvancing Equity and Justice
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC01 - PLENARY: Taking Stock of the Research Ethics Oversight Ecosystem: Healthy Developments, Overgrowth, and Audit CultureLocation: Ballroom 3
Moderator: – Perelman School of Medicine, University of Pennsylvania
Panelist: – UC San Diego
Panelist: – NIH
QA/QI and Postapproval MonitoringEmerging Research Challenges and Breaking Issues
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA EditionLocation: Ballroom 2
Speaker: – Advarra
Speaker: – University of Alabama at Birmingham
Speaker: – NYU Langone Health
Single IRBQA/QI and Postapproval MonitoringFDA Regulated Research
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC12 - Driving Postapproval Monitoring (PAM) Program Priorities by Harnessing Existing DataLocation: Room 445-446
Speaker: – Rutgers University
Speaker: – Allen Institute
Speaker: – University of Florida
QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and MembersLocation: Ballroom 3
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – University of Nebraska Medical Center
Speaker: – The PEER Consulting Group
QA/QI and Postapproval MonitoringIRB ReviewIRB Fundamentals
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE06 - Couch to QA/QI: Creating a QA/QI ProgramLocation: Room 345-346
Speaker: – Tufts University SBER IRB
Speaker: – Indiana University
QA/QI and Postapproval Monitoring
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF06 - Human Subjects Research Determinations: Before and After the FactLocation: Room 423-425
Speaker: – The Ohio State University Office of Responsible Research Practices
Speaker: – None
Education, Qualifications, and TrainingQA/QI and Postapproval MonitoringSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF15 - Avoiding the Slippery Slope: Complimenting Semi-annual Reviews With a Program of Ongoing QA/QI ReviewLocation: Room 331
Speaker: – formerly of Indiana University
Speaker: – Indiana University
Speaker: – Northwell Health - Feinstein Institutes for Medical Research
QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review BoardsLocation: Room 343-344
Speaker: – Clemson University
Speaker: – CDER/FDA/OC/OSI/DCCE
Speaker: – FDA/CDER/OC/OSI/DCCE
FDA Regulated ResearchHRPP/IRB Management and AdministrationPharma/Biotech PerspectivesQA/QI and Postapproval Monitoring
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG14 - No Findings? No Problem: Why Non-Issue Audits Still MatterLocation: Room 333-334
Speaker: – Penn State
Speaker: – Indiana University
Speaker: – Harvard T.H. Chan School of Public Health
IRB FundamentalsIACUC FundamentalsQA/QI and Postapproval Monitoring
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH03 - Houston, We Have Problem: Exploring Noncompliance in a Single IRB (sIRB) UniverseLocation: Ballroom 3
Speaker: – Baptist Health South Florida
Speaker: – University of Texas, MD Anderson Cancer Center
Speaker: – BRANY IRB
Single IRBQA/QI and Postapproval Monitoring
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH12 - Adverse Events and Animal Welfare in Biotech and Academia Alike: Creating Efficiency, an Open Program, and Automated Functions of ReportingLocation: Room 345-346
Speaker: – UC Berkeley
Speaker: – Novartis Biomedical Research, Inc.
Pharma/Biotech PerspectivesQA/QI and Postapproval MonitoringIACUC ReviewACU/IACUC Program Management and Administration
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH14 - Don't Reinvent the Wheel! How to Ask the Right Questions and Leverage Existing Resources to Address Critical Compliance NeedsLocation: Room 445-446
Speaker: – University of Nevada, Las Vegas
Speaker: – Western Washington University
Speaker: – KBR
Education, Qualifications, and TrainingShared Research Oversight ChallengesHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationQA/QI and Postapproval Monitoring
