Thank you for attending PRIMR24! You have 90 days to access the session recordings and evaluations, which will be unavailable after February 28, 2025. PRIM&R members will have free access to the recordings starting November 17, 2026, one year after the conference. Contact registration@primr.org with questions.
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated ProductsLocation: Room 431-432
Speaker: – Office of the Chief Medical Officer, FDA
Speaker: – Office of Scientific Investigations/CDER/FDA
Speaker: – US Food and Drug Administration
Speaker: – USFDA
FDA Regulated ResearchIRB ReviewPharma/Biotech Perspectives
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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 PTC06 - Medical Devices: A Beginner's Guide to Understanding the Basics of FDA Regulation and How to Apply it to a StudyLocation: Room 345-346
Speaker: – The Children's Mercy Hospital | Children’s Mercy Research Institute
Speaker: – The University of North Carolina at Chapel Hill
FDA Regulated ResearchIRB FundamentalsIRB Review
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD02 - When the Feds Come to Town: What to Expect from a Federal Site Visit or InspectionLocation: Room 347-348
Speaker: – DHHS, Office for Human Research Protections (OHRP)
Speaker: – FDA/CDER/OC/Office of Compliance
FDA Regulated ResearchHRPP/IRB Management and Administration, Compliance
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD05 - Are You Leaving Money on the Table? Ensuring IRB Fees Are Accounted for in a Single IRB (sIRB) World Location: Room 335
Speaker: – Northwestern University
Speaker: – Rutgers University
Speaker: – Stanford University
Single IRBFDA Regulated Research
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF03 - Key Information in Informed Consent: Ethical Principles, Policy, and PracticeLocation: Ballroom 2
Speaker: – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Speaker: – UC San Diego
Speaker: – University of California, Office of the President
Speaker: – Food and Drug Administration
FDA Regulated ResearchInformed Consent
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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
10:30 AM – 11:45 AM PTH01 - PLENARY: Regulatory and IRB Challenges in Reviewing Decentralized Clinical Trials (DCTs)Location: Room 323-324
Moderator: – Department of Veterans Affairs
Panelist: – DHHS Office for Human Research Protections
Panelist: – Decentralized Trials and Research Alliance
Panelist: – NCATS/NIH
FDA Regulated ResearchHRPP/IRB Management and AdministrationIRB Review
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH13 - Tick-Tock! How to Not Waste Your Time While Writing Minutes!Location: Room 423-425
Speaker: – Independent Professional
Speaker: – Office for Human Research Protections (OHRP)
Speaker: – Office of the Chief Medical Officer, FDA
FDA Regulated ResearchIRB ReviewIRB FundamentalsIACUC FundamentalsIACUC Review
