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What Every Research Compliance Professional Should Know About Clinical Research



Thursday, March 1, 2012
Product Code - lgn13
Speaker(s): F. Lisa Murtha, SNR Denton; Kevin R. Eskew, SNR Denton
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This program will provide a detailed overview of the laws and regulations that govern clinical research. The speakers will outline the federal government's expectations with respect to effective compliance programs and will provide concrete examples for illustration purposes. The speakers will also discuss practice strategies for tackling research compliance in a provider, life sciences or payer organization.

These are the basics that every research compliance professional or those working in research should know.

Educational Objectives:

• Understand the laws and regulations covering human research protections, conflicts of interest, research finance, scientific misconduct, research privacy and maintenance of data, and much more.

• Learn the substantive differences between the OHRP/Common Rule requirements and the FDA requirements for conducting clinical research.

• Learn of updates from the FDA and OHRP on human research protections, conflicts of interest, off label marketing.

• Understand how to expand their corporate compliance programs to include clinical and bench research oversight.

Who would benefit from attending?

• Research Compliance Professionals
• Lawyers
• Consultants
• Financial professionals
• Researchers
• Administrative Staff
• Physicians

Program Level: Intermediate

F. Lisa Murtha, SNR Denton; Kevin R. Eskew, SNR Denton

F. Lisa Murtha, Partner / SNR Denton
Lisa Murtha is a member of SNR Denton’s Health Care Group. Ms. Murtha has over 25 years of experience working on complex clinical research and healthcare compliance issues. She focuses her practice in corporate ethics and compliance programs, and in both sponsor and research site clinical research compliance which includes Physician Sunshine Act compliance, aggregate/promo spend issues, off-label use issues, issues related to payments to health care professionals, human subject protections, effort reporting/grant accounting, scientific misconduct, conflicts of interest, internal auditing and monitoring, and clinical trial billing and process improvement. Ms. Murtha's clients include large and small hospitals and health systems and academic medical centers as well as pharmaceutical and biotechnology companies. Ms. Murtha also provides guidance regarding revenue cycle work, billing and coding issues, internal investigations, compliance program effectiveness, corporate governance/ethics, and HIPAA related matters.

Author of numerous articles and books on research, healthcare compliance, and fraud and abuse topics in publications including HC Pro, The Journal of Health Care Compliance, Widener University Law Journal, The Philadelphia Business Journal, Aspen Publishers Compliance Handbook, Medical Research Law and Policy Report (BNA), The HCCA Compliance Newsletter, CCH publications, and Patient Safety Meets Corporate Compliance (Book-HCPro Publisher). Ms. Murtha's latest book on research compliance is published by BNA.

Ms. Murtha earned a J.D. from Dickinson School of Law and a B.A. from The Pennsylvania State University. She is certified in healthcare compliance in Pennsylvania and the District of Columbia.

Kevin R. Eskew, Managing Director / SNR Denton
Kevin Eskew is a managing director in SNR Denton's Health and Life Sciences practice. With more than 14 years of experience serving both health care and educational organizations as both an administrator and a management consultant, he regularly works with clients to improve their operational, organizational and financial effectiveness. He does this by taking actions to limit the impact of identified risks and uncover opportunities to enhance overall performance improvement, then designing actionable strategies that can protect a client's compliance management interests while fortifying market position.

Mr. Eskew has led numerous engagements aimed at improving the effectiveness of the clinical research programs of many different health care provider organizations. He also works extensively with health care organizations—including hospitals, academic medical centers, biopharmaceutical and managed care companies—to ensure compliance program effectiveness. His client experiences span work in organizational redesign, business process improvement, operations assessment and interim program leadership. He has also helped some major universities through non-salary cost reduction initiatives, conducted economic impact studies and led strategic planning and development projects for a number of health care and educational organizations. Mr. Eskew earned an M.B.A. from Indiana University and a B.A. from DePauw University. He is certified in healthcare compliance (CHC) by the Health Care Compliance Association.

 

This program is CLE-credit eligible.

If you have further questions regarding a specific state or how to file for CLE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the Legal and Business CLE Accreditation Coordinator.

Hardship Policy
Bloomberg BNA offers a hardship policy for any attorney earning less than $30,000 per year. If an attorney wishes to take advantage of this option, he or she must do so in writing and also provide proof of hardship. If approval is granted, a discount of 50% off the full registration price of the program will be awarded.

Questions
For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at http://www.abanet.org/cle/mandatory.html.

• Bloomberg BNA Subscriber - OnDemand format $199
• Non-Subscriber - OnDemand format $249
• CD recording of program $199 (Subscriber and Non-Subscriber)

Registration for Legal & Business programs is simple. You may either visit the registration page to register –or– call 1-800-372-1033, Option 6, and refer to the date and title of the program. Lines are open Monday through Friday from 8:00 a.m. to 8:00 p.m. ET.