Pre Conference Agenda

Sunday, October 18

9:00 am – 12:15 | Pre-Conference: Concurrent Breakout Sessions

P1 Effectively Preparing for and Responding to an FDA Audit: The Research Team’s Perspective

handout         evaluation survey

Stephanie C. Guzik, Assistant Director, Research Integrity and Regulatory Affairs, Rush University Medical Center
Kate-Louise Gottfried, JD, MSPH, Senior Director, Research Integrity, Rush University Medical Center
Alina Denis Jarjour, VP, Chief Compliance Officer & Deputy General Counsel, Medarex, Inc.

• Being FDA audit ready and audit procedures and communications with the FDA
• Investigator/research team response to an impending audit
• Minimizing the potential of an audit

P2 Grant Accounting Compliance

handout 1, handout 2         evaluation survey

Gabe Turner, Associate Director, Health Care Dispute, Compliance and Investigation, Navigant Consulting, Inc.
Mike Vernick, Partner, Hogan & Hartson

• Overview of the sources of grant accounting compliance rules, including OMB circulars and sponsor-specific guidance such as the NIH Grants Policy Statement
• Learn about key areas of grant accounting compliance, including effort reporting, cost transfers, cost sharing, service centers and distinguishing between direct and indirect charges
• Discuss recent federal enforcement activity related to the financial administration of federal grants

1:30 pm – 4:45 pm | Pre-Conference: Concurrent Breakout Sessions

P3 Research Compliance: A Year in Review

handout         evaluation survey

Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP
Kendra Dimond, JD, CHRC, Director, Daylight Forensic & Advisory

• A detailed overview of the most recent cases and administrative actions relating to research matters and research compliance
• A description of relevant laws, regulations or government guidance on research compliance in the areas of human research protections, scientific misconduct, research billing, conflicts of interest, effort reporting and much more
• Guidance on how to update your organization’s research compliance program to ensure that all critical areas are covered in appropriate detail including updates to training, auditing and monitoring, and policies and procedures

P4 Relationships with IRBs

handout 1, handout 2         evaluation survey

Cynthia Gates, VP Operations, Western Institutional Review Board
David Vulcano, AVP, Clinical Research, HCA

Part 1: Adverse Events: What Should Be Reported to the IRBs

• Definition of unanticipated problems
• How adverse events, IND safety reports fit within definition
• What should be included in the report

Part 2: Conducting a Basic Audit of an IRB

• Learn identifiable danger signs that an IRB is potentially negligent
• Create an audit tool to identify sentinel signs that an IRB is on the right or wrong track
• Learn ways of off-site review to decrease travel