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Human Subject Research - HSR

ACU/IACUC

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Monday, Nov 18th
1:45 PM – 3:00 PM PT
B08 - Empowering the Participant Voice: Using Research Participant Experience Data to Address Research Disparities and Enhance Quality
Location: Room 332
Speaker: Rhonda G. Kost, MD – The Rockefeller University
Speaker: Sana Khoury-Shakour, PhD, CCRP (she/her/hers) – University of California, Santa Cruz
QA/QI and Postapproval MonitoringAdvancing Equity and Justice
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C01 - PLENARY: Taking Stock of the Research Ethics Oversight Ecosystem: Healthy Developments, Overgrowth, and Audit Culture
Location: Ballroom 3
Moderator: Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania
Panelist: Eric C. Mah, EdD, MHS – UC San Diego
Panelist: Holly A. Taylor, PhD, MPH (she/her/hers) – NIH
QA/QI and Postapproval MonitoringEmerging Research Challenges and Breaking Issues
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA Edition
Location: Ballroom 2
Speaker: Joshua Fedewa, MS, CIP (he/him/his) – Advarra
Speaker: Adam J. McClintock, MBA, CIP – University of Alabama at Birmingham
Speaker: Nadia Johnson, MS, CIP – NYU Langone Health
Single IRBQA/QI and Postapproval MonitoringFDA Regulated Research
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C12 - Driving Postapproval Monitoring (PAM) Program Priorities by Harnessing Existing Data
Location: Room 445-446
Speaker: Isabela D. Freedman, PhD, CPIA (she/her/hers) – Rutgers University
Speaker: Shannon Ramsey (she/her/hers) – Allen Institute
Speaker: Kendra Rooks, LVT, RLATG, CPIA (she/her/hers) – University of Florida
QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration
Tuesday, Nov 19th
10:30 AM – 11:45 AM PT
D07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and Members
Location: Ballroom 3
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: Bruce G. Gordon, MD (he/him/his) – University of Nebraska Medical Center
Speaker: George Gasparis – The PEER Consulting Group
QA/QI and Postapproval MonitoringIRB ReviewIRB Fundamentals
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E06 - Couch to QA/QI: Creating a QA/QI Program
Location: Room 345-346
Speaker: Paul G. Hart, JD, MA, CIP (he/him/his) – Tufts University SBER IRB
Speaker: Neala J. Lane, MS, CCRC (she/her/hers) – Indiana University
QA/QI and Postapproval Monitoring
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F06 - Human Subjects Research Determinations: Before and After the Fact
Location: Room 423-425
Speaker: Jake Stoddard, BA, CIP – The Ohio State University Office of Responsible Research Practices
Speaker: Ivor A. Pritchard, PhD (he/him/his) – None
Education, Qualifications, and TrainingQA/QI and Postapproval MonitoringSocial, Behavioral, and Educational Research
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F15 - Avoiding the Slippery Slope: Complimenting Semi-annual Reviews With a Program of Ongoing QA/QI Review
Location: Room 331
Speaker: John R. Baumann, PhD (he/him/his) – formerly of Indiana University
Speaker: Mégan Losh, MPA, CPIA (she/her/hers) – Indiana University
Speaker: Michelle Aparicio, MBA, CPIA – Northwell Health - Feinstein Institutes for Medical Research
QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review Boards
Location: Room 343-344
Speaker: Nalinee D. Patin, CIP (she/her/hers) – Clemson University
Speaker: Kassa Ayalew – CDER/FDA/OC/OSI/DCCE
Speaker: Cheryl Grandinetti, PharmD (she/her/hers) – FDA/CDER/OC/OSI/DCCE
FDA Regulated ResearchHRPP/IRB Management and AdministrationPharma/Biotech PerspectivesQA/QI and Postapproval Monitoring
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G14 - No Findings? No Problem: Why Non-Issue Audits Still Matter
Location: Room 333-334
Speaker: Courtney Karmelita, D.Ed (she/her/hers) – Penn State
Speaker: Neala J. Lane, MS, CCRC (she/her/hers) – Indiana University
Speaker: Alyssa AK Speier, MS, CIP (she/her/hers) – Harvard T.H. Chan School of Public Health
IRB FundamentalsIACUC FundamentalsQA/QI and Postapproval Monitoring
Wednesday, Nov 20th
10:30 AM – 11:45 AM PT
H03 - Houston, We Have Problem: Exploring Noncompliance in a Single IRB (sIRB) Universe
Location: Ballroom 3
Speaker: Scott J. Lipkin, DPM, CIP – Baptist Health South Florida
Speaker: Hallie Kassan, MS,CIP (she/her/hers) – University of Texas, MD Anderson Cancer Center
Speaker: Raffaella Hart, MSHS, CIP (she/her/hers) – BRANY IRB
Single IRBQA/QI and Postapproval Monitoring
Wednesday, Nov 20th
10:30 AM – 11:45 AM PT
H12 - Adverse Events and Animal Welfare in Biotech and Academia Alike: Creating Efficiency, an Open Program, and Automated Functions of Reporting
Location: Room 345-346
Speaker: Richelle L. Scales, B.Sc., CPIA (she/her/hers) – UC Berkeley
Speaker: Amy F. Kilpatrick, BA, RLATG, CVT, CPIA (she/her/hers) – Novartis Biomedical Research, Inc.
Pharma/Biotech PerspectivesQA/QI and Postapproval MonitoringIACUC ReviewACU/IACUC Program Management and Administration
Wednesday, Nov 20th
10:30 AM – 11:45 AM PT
H14 - Don't Reinvent the Wheel! How to Ask the Right Questions and Leverage Existing Resources to Address Critical Compliance Needs
Location: Room 445-446
Speaker: Nyssa Towsley, MS, CIP (they/she) – University of Nevada, Las Vegas
Speaker: Andrea R. McDowell, PhD (she/her/hers) – Western Washington University
Speaker: Elaine K. Kim, BS, CPIA (she/her/hers) – KBR
Education, Qualifications, and TrainingShared Research Oversight ChallengesHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationQA/QI and Postapproval Monitoring