he Research Compliance Conference you cannot miss if you work for a sponsor, a research site, or for clinicians who conduct research Learn about updates to the new CMS Clinical Research Policy (replacing the Medicare NCD for Clinical Trials), latest trends on compliance with research accounting standards, clinical trial billing and process improvement, effort reporting, scientific misconduct, conflicts of interest, off-label use issues, FDA compliance, and government enforcement trends. Hear directly from representatives from NIH, OHRP, ORI, the FDA, the OIG, and the DOJ, and from other industry experts who can provide practical perspectives for handling research compliance risks.
   
 

  • Pre-Conference Wed 4/21
  • Conference Thurs 4/ 22
  • Conference Fri 4/23
  • Post Conference Sat 4/24
Wednesday, April 21 — Pre-conference

Breakout Sessions

12:00 – 2:00 pm

P1: Research Compliance 101
Kevin Eskew, Managing Director, Sonnenschein, Nath & Rosenthal, LLP; Fred Herman, Manager, Research Compliance, University of Maryland Medical System, Department of Finance
  P2: New FDA Enforcement Frontier
Rachel Nosowsky, Esq., CHRC, Senior Counsel, Miller Canfield Paddock & Stone, PLC; Rick Robinson, Partner, Fulbright & Jaworski LLP

Breakout Sessions

2:30 – 4:30 pm

P3: Faculty Training for Research Compliance Professionals
Angelique Dorsey, Research Compliance Director, MedStar Health; Carolyn Whitmire
  P4: Raising the Bar on Adequate Human Subject Protection
Cynthia Gates, VP Operations,Western Institutional Review Board; Jeffrey A. Cooper, MD, MMM, Director, Huron Consulting Group
Thursday, April 22    
7:30 – 8:30 am Breakfast

GENERAL SESSION

8:30 – 9:45 am

GS1: 2010 Update from OHRP and ORI
JoAn Rochez, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services; Laura Odwazny, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services
Networking Break 9:45 – 10:15 am

Breakout Sessions

10:15 – 11:45 am

101: How ARRA HITECH Rule Affects Research Data
Joy Hardee, Administrator, UHS Privacy Officer/Research Compliance, University Health Systems of Eastern Carolina; Carole A. Klove, RN, JD, CHRC, Special Projects, UCSF Medical Center
  102: Conflicts of Interest in Research: Ethical, Regulatory and Practical Considerations
Suzanne Rivera, Associate Vice President, UT Southwestern Medical Center; Ann N. James, PhD, JD, Senior University Counsel, OGC, Stanford University
  103: The Ten Steps to an Effective Research Compliance Program: A Practicum for Research Compliance Professionals
Luanna Putney, Systemwide Director of Research Compliance, University of California; Juliann Tenney, Institutional Research Compliance Officer, Director of the
Institutional Research Compliance Program and Privacy Officer, University of North Carolina at Chapel Hill
       

Lunch Speaker

11:45 am – 12:45 pm

International Research
Mark Barnes, (invited) Harvard University

       

Breakout Sessions

12:45 – 2:15 pm

201: Managing Regulatory Compliance for Investigator-Initiated Research
Leah R. Kendall, Senior Associate, Epstein Becker & Green; Thomas Bechert, Manager, Huron Consulting Group
  202: Ensuring a Sound, Compliant Animal Care and Use Program in a Changing (and Challenging) Landscape
Kathy Wadsworth, Director, Office of Animal Research Oversight (OARO), University of California, Los Angeles
  203: Data Security in Research: Is the IRB Responsible?
Russell Opland, Systemwide Privacy Officer, University of California; Marian Hughlett, Deputy Privacy Officer, University of Louisville
Networking Break 2:15 – 2:45 pm  

Breakout Sessions

2:45 – 4:15 pm

301: Case Studies in Clinical Research Fraud Enforcement
Jesse Witten, Partner, Drinker Biddle & Reath LLP; Gary Eiland, Partner, King& Spalding LLP
  302: Developing an Effective Anti-Bribery and Corruption Compliance Program in an Environment of Heightened Enforcement
Jay Perlman, Director, Daylight Forensic & Advisory LLC
  303: The Learnings of a Developing Clinical Trials Office Within an Established Teaching Hospital
Eve Sakran, MS, Director, JHS Clinical Trials Office, Jackson Health System, Miami, FL; Ljudmila Hadzikadunic, RN, JD, Compliance Manager, Jackson Health System
Networking Break 4:15 – 4:30 pm  

GENERAL SESSION

4:30 – 5:30 pm

GS2: Grants Management Compliance and OPERA
Diane Dean (invited) (OPERA); Joe Ellis (invited)
     
Networking Reception 5:30 – 6:30 pm  
Friday, April 23
Continental Breakfast 7:30 – 8:30 am  

GENERAL SESSION

8:30 – 9:45 am

GS3: Research Compliance: A Year in Review
Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP; Kendra Dimond, JD, CHRC, Director, Daylight Forensic & Advisory
Networking Break 9:45 – 10:15 am  

GENERAL SESSION

10:15 – 11:15 am

GS4: FDA Presentation
Speaker TBA
Networking Luncheon 11:30 – 12:30 pm  

Breakout Sessions

12:30 – 2:00 pm

401: Compliance Challenges in Establishing and Using Clinical Databases
Melissa (Lisa) Thompson, Senior Counsel, Fulbright & Jaworski LLP; Betsy Hall, Director of Corporate Compliance, Privacy and Information Security, Jewish Hospital & St. Mary’s HealthCare, Inc. (JHSMH)
  402: Unanticipated Problems in Human Subject Research: Beyond Adverse Events
Keren Dunn, CIP, Manager, Research Compliance& Quality Improvement, Cedars-Sinai Medical Center; Andra M. Popa, JD, LLM, CHC, CHRC, Consultant, Meade & Roach, LLP
  403: Research Misconduct: Detection and Risk Mitigation Solutions
Susan S. Night (invited), Health Policy and Ethics Fellow, Baylor College of Medicine; Sheryl Tatar Dacso (invited), Partner, Brown McCarroll
Networking Break 2:00 – 2:30 pm    

Breakout Sessions

2:30 – 4:00 pm

501: Export Controls Compliance
Don Fischer, Fischer & Associates, Export Control Consulting
  502: Off-Label Drugs and Devices: The Woes of Their Use, Promotion and Payment
Neil O’Flaherty (invited), Principal Attorney, Olsson Frank Weeda Terman Bode Matz PC; Jill Alverez (invited)
  503: Developing a Research Compliance Program in the Context of Corrective Actions to an OHRP Investigation
Michael Roach, Partner, Meade & Roach, LLP; Ron Sagritalo, Corporate Compliance Officer, Carle Clinic Association
Saturday, April 24 — Post-Conference
Beverages 7:30 – 8:30 am    

Breakout Sessions

8:30 – 11:30 am

W1: Research Risks: What’s the Assessment?
Margaret Hambleton (invited), MBA, CPHRM, CHC, Senior Vice President, Ministry Integrity for St. Joseph Health System; John E. Steiner, Jr, Esq., CHC, CCEP, Chief Compliance Officer, Cancer Treatment Centers of America
  W2: ARRA Reporting Requirements —Regulatory Overview
Jana Aagaard (invited), Of Counsel, Catholic Healthcare West, Sacramento Office, Legal Department
       
1:00 – 3:00 pm CCEP Exam

Program | Hotel/City | Certification | Exhibit/Sponsor | Registration