Sunday, June 4 | Pre-Conference
SESSION |
SPEAKER |
P1 | The Most Challenging Provisions in CTAs
Presentation (2 slides/page) |
Michael C. Roach, Managing Director, Aegis Compliance & Ethics Center, LLP |
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P2 | Investigator Initiated Trials: Common Startup Struggles and Oversights
Presentation (2 slides/page) |
David B. Russell, Director, Site Strategy, PFS Clinical Liz Christianson, Senior Clinical Research Analyst, PFS Clinical |
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P3 | Enterprise Solutions for Implementing Effective Corrective Action and Prevention Plans (CAPA) Following Internal Audits of Clinical Research Trials
Presentation (2 slides/page) |
Ann N. Sieber, MS, CIP, CHRC, Dir, Clinical Research Services, Sponsored Program Administration, UT Southwestern Medical Center Deepika Bhatia, MSBME, CCRP, CHRC, Assist. Director - Research & Academics Compliance, UT Southwestern Trissi S. Gray, MBA, CHRC, Assistant Director, Health System Compliance, UT Southwestern Med Center |
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P4 | How Research Risks Affect Compliance
Presentation (2 slides/page) |
Sarah Fowler-Dixon, Education Specialist, Human Research Protection Office, Washington University School of Medicine |
Monday, June 5
SESSION |
SPEAKER |
General Session 1 |
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F. Lisa Murtha, Senior Managing Director, FTI Consulting |
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101 | Against Tradeoffs: Improving Compliance and Researcher Satisfaction
Presentation (2 slides/page) |
Matthew W. Staman, Managing Director, Huron Consulting Group Marisa Zuskar, Director, Huron Consulting Group Anne Pifer, Senior Director, Huron Consulting Group
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102 | Compliance Implications for the Commercialization of Federally Funded Research
Presentation (2 slides/page) |
Bethany H. Loftin, Chief Operating Officer, TreMonti Consulting LLC Ann Hammersla, Dir., Div of Extramural Invent. and Tech Resources, National Institutes of Health |
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201 | The Intersection Between Medicare Coverage Analysis, IRB Review, and Informed Consent
Presentation (2 slides/page) |
Linn Defensor, Sr. MCA Analyst, Cedars-Sinai Medical Center Keren Dunn, Manager, Research Compliance & QI, Cedars-Sinai Medical Ctr. |
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202 | Managing Preclinical Risk to Protect Data Integrity, Animal Welfare, and Human Subject Safety
Presentation (2 slides/page) |
Stephen A. Frattini, DVM, Preclinical Research Compliance Manager, Northwell Health Alison Powell, Research Compliance Manager, Northwell Health |
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301 | Want to Participate in Research? There’s An App for That: Security and Privacy Issues with the Increased Use of Connected Devices, Apps and Social Media In Research
Presentation (2 slides/page) |
Marti Arvin, Vice President, Audit Strategy, CynergisTek, Inc David Mata, Senior Associate, Aegis Compliance and Ethics Center |
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302 | Managing Research Compliance Utilizing an Electronic Compliance Database System
Presentation (2 slides/page) |
Mike Jensen, Intermountain Healthcare |
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ADVANCED DISCUSSION 303AD |
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Kelly Willenberg, Owner, Kelly Willenberg and Associates |
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401 | Where Is the Data? Risks of Data Location, Storage and Protection of Sensitive Protected Health Information (PHI)
Presentation (2 slides/page) |
Margaret M. Groves, Associate Compliance Officer, HSRC, Duke University Office of Audit, Risk and Compliance Holly B. Benton, Director, Privacy Compliance, Duke University Office of Audit, Risk and Compliance |
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402 | Finding Flexibility in the IRB Regulations: How to Reduce Burden
Presentation (2 slides/page) |
Mariette Marsh, Director, Human Subjects Protection Program, The University of Arizona |
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General Session 2 |
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Laura Odwazny, Senior Attorney, Public Health Division, Office of the General Counsel, U.S. Department of Health and Human Services |
Tuesday, June 6
SESSION |
SPEAKER |
General Session 3 |
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Margaret (Peg) Hutchinson, Chief, Civil Division, U.S. Attorney’s Office for the Eastern District of Pennsylvania |
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501 | Creating Infrastructure Support for Investigator-Initiated Research
Presentation (2 slides/page) |
Karen A. Hartman, Administrator - Research Compliance, Mayo Clinic
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502 | Defining and Streamlining Review of Reportable Events
Presentation (2 slides/page) |
Emily Smotherman, Research Comp Mgr, Children’s Healthcare of Atlanta Sarah Marie Huban, IRB Manager, Children’s Healthcare of Atlanta |
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ADVANCED DISCUSSION 503AD |
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Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law |
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601 | Effectively Managing and Monitoring Controlled Substances in Research
Presentation (2 slides/page) |
Emmelyn Kim, AVP, Research Compliance & Privacy Officer, Northwell Health Ji-Eun Kim, Research Pharmacist, Northwell Health |
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602 | The Federal What…?
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Robert S. Bienkowski, Director of Research Compliance, Central Michigan University |
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701 | Navigating Animal Research Compliance and Managing Risks
Presentation (2 slides/page) |
Denise Ancharski-Stutler, Assistant Director, Post-Approval Monitoring, Children’s Hospital of Philadelphia |
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702 | Sharing Is Caring: HHS Final Rule on Clinical Trials Registration and Results Information Submission
Presentation (2 slides/page) |
Anne Ruff, Attorney, Hall, Render, Killian, Heath & Lyman, PC |
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801 | ClinicalTrials.gov: The Push for More Transparency, and How Your Institution Can Keep Up with the Expanded Requirements, Tackle Systematic Changes, and Prepare for Enforcement
Presentation (2 slides/page) |
Diane Wilson, Compliance Specialist, Lead, University of Michigan Med School Emily Ouellette, QI Program Assistant Director, FDA and Regulatory Support, Partners HealthCare |
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802 | Re-Organize the Research Program to Minimize Legal Risk and Maximize Compliance: A Case Study
Presentation (2 slides/page) |
Emma A. Meagher, MD, Vice Dean for Clinical Research & Chief Clinical Research Officer, Perelman School of Medicine, University of Pennsylvania |
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General Session 4 |
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Moderator: Melanie R. Kay, Director, Daniels Fund Ethics Initiative, University of Colorado Law School Alice M. BrightSky, Senior Director, Compliance Programs, Fordham Law School Colleen Dorsey, Esq., Director, Organizational Ethics & Compliance, University of St. Thomas |
Wednesday, June 7 | Post-Conference
SESSION |
SPEAKER |
W1 | Understanding and Applying the Guidance in Part 6: Internal Controls of the OMB Compliance Supplement
Presentation (2 slides/page) |
Matthew W. Staman, Managing Director, Huron Consulting Group Marisa Zuskar, Director, Huron Consulting Group |
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W2 | A Primer on Human Subject Protection Regulations for the Compliance Professional
Presentation (2 slides/page) |
Scott Lipkin, DPM, CIP, Managing Director, Research & Compliance, FTI Consulting
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W3 | Research Compliance Structures and Quality Systems
Presentation (2 slides/page) |
Johanna J. Stamates, Executive Director, University of Miami |
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W4 | Research Compliance Programs: Always a Work in Progress
Presentation (2 slides/page) |
Dwight Claustre, Director, Aegis Compliance & Ethics Center, LLP Karen Mottola, Research Compliance Officer, Sutter Health |