Monday, September 18
GENERAL SESSION
Clinical Trials and the FDA—What You Really
Need to Know
Doreen Kezer, Branch Chief, FDA/Office of Compliance
Document 1
- What is a medical device and why is compliance necessary
in device research?
- CDRH BIMO Inspection Program overview
- What should you do when a FDA Inspector shows up at your site?
10:30 – 11:45 AM
GENERAL SESSION
The Enforcement Agenda for Research
Jim Sheehan, Associate US Attorney, Eastern District of PA
Document 1
12:00 – 1:30 PM
LUNCH & SPEAKERS
What’s New in Human Subject Protections
Mark Barnes, Partner, Ropes & Gray
Document 1
- Tissue and data banking in the aftermath of the Washington
University v. Catalona decision The growing number of clinical trials in developing countries and the
implications for industry and academic medical centers New Medicare interpretations of rules relating to billing for services in
clinical trials
- Grant and contract compliance and the recent OIG settlements
1:45 – 3:00 PM
CONCURRENT BREAKOUT SESSIONS
101 Recent Developments in Clinical Trials
and the NCD
Cynthia Boyd, Associate Vice President, Chief Compliance Officer,
Rush Medical Center
Ryan Meade, Meade & Roach
Document 1
- Discussion of CMS Clarifications on the Clinical Trials NCD
- Survey of industry approaches to simplified ways to comply with the
Clinical Trials NCD
- How compliance program auditing and monitoring plans should
incorporate Clinical Trials billing issues
102 Ethical Conflicts of Interest and Clinical Research: What’s Hot and What’s Not?
Kendra Dimond, Director, Huron Consulting Group
Stuart Horowitz, Director, Research Institute, Miami Children’s Hospital
Document 1, Document 2
- Identify investigators’ real and perceived financial conflicts of interest
and develop effective strategies to manage or eliminate them
- Identify institutional financial conflicts of interest and work within
their institution to protect not only human subjects but also the
institution’s public trust
- Identify non-financial conflicts of interest and understand their
potential influence on the responsible conduct of research
103 Common Challenges in Industry—Academia
Collaboration
Mark Waxman, Partner, Foley & Lardner
Document 1, Document 2, Document 3, Document 4, Document 5, Document 6
- Key federal laws designed to protect patients
- What federal laws affect payment to clinical sites?
- The alternative structures—subgrants and collaborations
- How to handle the oversight and compliance responsibility
104 Dealing with a Government Investigation
Frank Sheeder, Partner, Jones Day
Sean McKenna (invited), Assistant United States Attorney,
U.S. Attorney’s Office Northern District of Texas
Document 1
- Government expectations
- Common challenges
- Practical approaches
3:30 – 4:45 PM
CONCURRENT BREAKOUT SESSIONS
201 Effort Reporting—the Latest Developments
and Recent Cases
Holley Thames Lutz, Partner, Sonnenschein Nath & Rosenthal LLP
Terry L. Reeves, Executive Director of Compliance, Office of Institutional
Compliance University of Texas Medical Branch
Document 1, Document 2, Document 3
- Review and understand practical examples of reconciling effort
reported and salary paid
- Understand why key policies and procedures must be in place and
functioning in order to practically administer effort reporting
- Understand why definitions and policies regarding key salary and
effort concepts are crucial to the effort reporting process
- Discuss pitfalls of an inadequate effort reporting process
202 Compliance with Good Clinical Practice
Standards—and What’s New with GMP-F
Lisa Murtha, Managing Director, Huron Consulting Group
John Steiner, Chief Compliance Officer, University of Kentucky
Document 1
- Overview of the overlap and distinctions between GCPs and the
Common Rule
- Practical summary of how to train and audit your organization’s
clinical research studies to ensure ongoing compliance with GCPs
and GMPs
203 Clinical Trial Billing—How to Minimize Risk
and Maximize Compliance
Mary Schumer, Research Administrator, University of Colorado Hospital
Roger Gopolan, Chief Compliance Officer, Director of Internal Audit,
University of Colorado Hospital
Document 1
- Potential hazards of incorrectly billing insurance or
governmental payers
- Regulations that govern clinical trial billing
- Determining which services should be billed to clinical trail grants
- Policies and procedures to ensure accurate billing for services
provided to clinical trails
- On-going auditing of clinical trial billing compliance
204 How to Audit Compliance with Federal Grant
Requirements
Matthew Staman, Director, Huron Consulting Group
No documents available
- Understand key compliance risks related to managing federal grants
- Review approaches to assessing and monitoring compliance
- Discuss the importance of matching monitoring approaches to your
institutional risk profile
Tuesday, September 19
9:00 - 10:15 AM
GENERAL SESSION
Research Misconduct: Recent Developments
Brian D. Bewley, Office of the General Counsel, Public Health Division,
U.S. Department of Health and Human Services
Document 1
- Model research misconduct policy and procedures
- Recent cases
- Administrative actions
10:30 – 11:45 AM
GENERAL SESSION
Off-Label Use of Drugs and the Enforcement
Implications
Michael Kendall, Partner, McDermott, Will & Emery
Susan Winkler, Assistant U.S. Attorney, Chief of the Healthcare Fraud Unit,
U.S. Attorney’s Office, District of Massachusetts
Document 1
- Risk areas and off-label issues that prosecutors are investigating
- How to limit your risk in the off-label area
- What does the law permit?
1:15 – 2:30 PM
CONCURRENT BREAKOUT SESSIONS
301 Informed Consent: The Theory, The Cases, and
The Process
Jerry Menikoff, Associate Professor of Law, Ethics, & Medicine, University of
Kansas
Document 1
- Learn about how state tort law imposes legal requirements on
researchers beyond those of the federal Common Rule
- Learn the state-to-state differences in what must be disclosed to
research subjects
- Learn now about the likely upcoming legal battles over disclosure
requirements, so that you can meet those requirements without ending
up in litigation
302 Internal Investigations & Research
John Beattie, Principal, Parente Randolph
Document 1
- Applicable compliance criteria
- Task plan development and auditing techniques
- Reporting results
303 Clinical Research Outside the Academic Medical Center, Compliance and Legal Pitfalls
Jennifer Geeter, McDermott, Will & Emery
Bernadette Broccolo, McDermott, Will & Emery
Document 1
- The changing realities of biomedical research—new players, roles,
relationships, opportunities and strategies
- Emerging compliance requirements and risks that exceed the
jurisdiction and capacity of IRBs
- Establishing a centralized, comprehensive research program to
capture opportunities and manage risks
304 Waivers of Informed Consent for Emergency
Research: What Can We Learn from
PolyHeme®’s Experience?
John Mills, Legal Counsel, Mayo Clinic
Document 1
- Outline the legal requirements for an IRB to waive the informed
consent requirement for emergency research
- Discuss the controversy unfolding in the national media related to a
study of the blood substitute, PolyHeme®
- Discuss how the controversy over the PolyHeme® study can help
inform the process for future waiver requests
3:00 – 4:15 PM
CONCURRENT BREAKOUT SESSIONS
401 Privacy and Security Issues in Clinical Research
Marti Arvin, Privacy Officer, University of Louisville
Document 1
- Creative ways to deal with the continuing challenges of maintaining
the privacy and security of protected health information in research
- The expansion of electronic health records and how this will impact
the use of de-identified and limited data sets in research
- The impact of the HIPAA enforcement rule on uses and disclosures of
protected health information in research
402 Crossing the Line: Research vs. Innovative Care
and Quality Reporting
Carole Klove, Chief Compliance Officer and Privacy Officer, UCLA Healthcare
and Medical Sciences
Julianne Tenney, Associate Dean for Compliance, Duke University School of Medicine
Document 1
- Understand the scope of clinical trials and clinical research
- Explore when innovative care crosses over into clinical research and its
impact on quality of care and other regulatory and compliance regulations
- Examine ways to structure the process to support innovative care and
clinical research in your hospital or health system
403 Clinical Research - The Intersection Between Commercial Interests and Government Regulation
Michael Mustokoff, Partner, Duane Morris, LLP
Document 1
- A review of recent fraud cases brought against clinical researchers and
institutions
- Strategies to avoid becoming the target of a government investigation
- An examination of the intersection between the regulatory framework
and the government’s enforcement practices
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