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HCCA's Research Compliance Conference
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SCCE's Conference for Effective Compliance Systems in Higher Education
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Conference Set
Pre-Conference
General Sessions
Concurrent Session I (Thursday 10:00 AM to 11:30 AM)
Concurrent Session II (Thursday 12:45 PM to 2:15 PM)
Concurrent Session III (Thursday 2:45 PM to 4:15 PM)
Concurrent Session IV (Friday 12:30 PM to 2:00 PM)
Concurrent Session V (Friday 2:30 PM to 4:00 PM)
Saturday, Post-Conference Sessions
Conference Set
CON Online Access Synchronized to PowerPoint
CON1 CD-ROM Synchronized to PowerPoint
CON3 Research Compliance Conference and SCCE Higher Education Conference CD-ROMs
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Pre-Conference
RP1 Research Compliance 101 — Kevin Eskew, Fred Herman
RP2 FDA's New Enforcement Agenda: What It Means to Clinical Investigators and IRBs — Rachel Nosowsky, Rick Robinson
RP3 Faculty Training for Research Compliance Professionals — Angelique Dorsey
RP4 Raising the Bar on Adequate Human Subject Protection — Cynthia Gates, Jeffrey A. Cooper, MD
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General Sessions
RGS1 Opening Remarks / 2010 Update from OHRP and ORI — Jo An Rochez, Laura Odwazny
RGS2 International Research — Dr. Melody Lin
RGS3 Opening Remarks / Research Compliance: A Year in Review — Lisa Murtha, Kendra Dimond
RGS4 An FDA Report: Physician Initiated Device Studies at Academic Medical Centers — Anne T. Hawthorn
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Concurrent Session I (Thursday 10:00 AM to 11:30 AM)
R102 Case Studies in Clinical Research Fraud Enforcement — Jesse Witten, Gary W. Eiland
R103 Developing a Research Compliance Program in the Context of Corrective Actions to an OHRP Investigation — Michael Roach, Ron Sagritalo
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Concurrent Session II (Thursday 12:45 PM to 2:15 PM)
R201 Managing Regulatory Compliance for Investigator-Initiated Research — Leah R. Kendall, Thomas Bechert
R202 Ensuring a Sound, Compliant Animal Care and Use Program in a Changing (and Challenging) Landscape — Kathy Wadsworth
R203 Data Security in Research: Is the IRB Responsible? — Russell Opland, Marian Hughlett
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Concurrent Session III (Thursday 2:45 PM to 4:15 PM)
R301 Conflicts of Interest in Research: Ethical, Regulatory, and Practical Considerations — Suzanne M. Rivera, PhD., Ann N. James, PhD.
R302 Developing an Effective Anti-Bribery and Corruption Compliance Program in an Environment of Heightened Enforcement — Jay Perlman, Joel Rush
R303 The Learnings of a Developing Clinical Trials Office Within an Established Teaching Hospital — Eve Sakran, Ljudmila Hadzikadunic
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Concurrent Session IV (Friday 12:30 PM to 2:00 PM)
R401 Compliance Challenges in Establishing and Using Clinical Databases — Melissa (Lisa) Thompson, Betsy Hall
R402 Unanticipated Problems in Human Subject Research: Adverse Events and Beyond — Keren Dunn, Andra M. Popa
R403 Research Misconduct: Detection and Risk Mitigation Solutions — Susan S. Night, Sheryl Tatar Dacso
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Concurrent Session V (Friday 2:30 PM to 4:00 PM)
R501 Managing Export Control Compliance in Biomedical Research — Don Rischer
R502 Off-Label Use vs. Clinical Trial Use of Devices: FDA Regulatory Issues — Neil O'Flaherty
R503 The Ten Steps to an Effective Research Compliance Program: A Practicum for Research Compliance Professionals — Luanna Putney, Juliann Tenney
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Saturday, Post-Conference Sessions
RW1 Research Risks: What's the Assessment? — Margaret Hambleton, John E. Steiner Jr.
RW2 The Closer: Resolve the Risky Business of Billing Compliance — Kathleen Hurtado, Kelly Willenberg
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