HCCA's Research Compliance Conference

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