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2012 Conference Agenda
- Pre-Conference Sun 6/03
- Conference Mon 6/04
- Conference Tues 6/05
- Post Conference Wed 6/06
| Sunday, June 3 — Pre-conference |
| 11:30am – 6:00pm |
Registration |
Pre-Conference Sessions
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P1: IRB Updates
- This will significantly impact research compliance in your organization
- This will require a significant "attitude adjustment" on the part of IRBs
- This is a very big deal!
Jeffrey P. Braff, DrPH Director, Human Research Protections, Kaiser Permanente
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P2: Research Billing Compliance
- Define risk areas with billing for clinical trial services
- Identify process for integration with research, hospital and clinic teams to get it right
- Provide audit tools and outcomes from hardwiring research billing module in EPIC system
Ruth Krueger, Regional Director of Corporate Compliance, Sanford Health
Eve Sakran, Director Clinical Trials Office, Jackson Health System
Diana Salinas, Esq., CHC, Corporate Director and Chief Compliance Officer, Jackson Health System
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Breakout Sessions
3:30 – 5:00 pm |
P3: Implications of Transparency Reports and Updates on Institutional COI
Luanna Putney, Ph.D., CHC, CCEP Director of Research Compliance University of California
David Vulcano, LCSW, MBA, CIP, RAC AVP & Responsible Executive, Clinical Research, Clinical Services Group HCA
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P4: Research Conflicts of Interest
- Learn the requirements of COI disclosure for research, clinical and business relationships
- Review a combined approach to institutional COI policy
- Experience a one stop approach for annual COI surveys and reports.
Janis Anfossi, Associate General Counsel, Rush University Medical Center
Tim Cleary, Greenwich Hospital Compliance & Privacy Officer, Yale New Haven Health System
Tracy E. Miller, Senior Member, Health Care Group, Cadwalader Wickersham & Taft
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| 5:00 – 6:30 pm |
Welcome Reception |
| Monday, June 4 |
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| 7:00am – 6:00pm |
Registration |
| 7:00 – 8:15 am |
Breakfast |
| 8:15 – 8:30am |
Opening Remarks |
GENERAL SESSION 1
8:30 – 9:30 am |
Research Compliance: A Year in Review
Lisa Murtha, Esq. Partner, SNR Denton US LLP
Rachel Nosowsky, Principal Counsel, University of California
David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, Clinical Services Group HCA
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| 9:30 – 10:00 am |
Networking Break |
101: Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities - The Impact on Clinical Research Sites
- Recent regulatory requirements for increased transparency will affect researchers
- Increased government scrutiny on pharmaceutical and medical device manufacturers' R&D activities
- Actions research sites can take to mitigate risk
MaryAnn Northrup, Associate Director, Navigant Consultant
Heather M. O’Shea, Partner, Jones Day
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102: Fabrication, Falsification and Plagiarism: Complying with Federal Regulations on ResearchMisconduct
- Gain an understanding of the Office of Research Integrity and its functions
- Learn the key components for handling a misconduct allegation
- Hear actual case examples
Randy Mason, Vice President, Research Operations, Beth Israel Deaconess Medical Center
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103:
Your Medical Staff is Conducting Clinical Research. Are you Prepared and Protected? Special Challenges for Community Hospitals
- Risks faced by community hospitals when unemployed medical staff do clinical research
- How some hospitals attempt to minimize those risks
- How to get the medical staff to go along
Michael C. Roach, Partner, Meade & Roach, LLP
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11:30 am – 12:45 pm |
Networking Luncheon |
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Breakout Sessions
12:45 – 2:15 pm |
201: Clinical Research Enforcement Initiatives and False Claims Act Update
- Practical strategies for assessing internal compliance and minimizing False Claims Act risks
- Kickback, PATH and other initiatives
Gary W. Eiland, Partner, King & Spalding LLP
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202: A Successful IRB Model for Handling Noncompliance Cases (Emory's Experience)
- Learn about a successful, streamlined model for IRB handling of noncompliance!
- Struggling with how to manage noncompliance reviews by your IRB? This session is for you.
- How your IRB can efficiently, fairly, and confidentially handle reports of noncompliance
Sarah B. Putney, IRB Director, Emory University
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203:
Research Compliance Management Project Review & Centralized Research Registration
- Conducting a pre-review of research projects for billing compliance
- Using electronic research management system
- Using a centralized research notification and registration process
Kurt Sargent, MBA, CPA, Manager, Sponsored Projects, Allina Health System
Carmi Anderson, Research Compliance Specialist, Sponsored Projects, Allina Hospital's Clinics
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| 2:15 – 2:45 pm |
Networking Break |
Breakout Sessions
2:45 – 4:15 pm |
301: Comprehensive Risk Assessments to Fuel Research Compliance
- Learn the power of a comprehensive risk assessment when optimizing your risk management efforts.
- This analysis features a wide range of risks: Regulatory agencies, financial requirements, clinical/legal risks.
- The presentation includes an overall survey of risks plus drill downs on key topics.
Daniel E. Ellis, President, 20/20 Healthcare Advisory Services, Ltd.
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302: Clinical Trial Disclosure and the Risk of Non-Compliance
- Discuss current and future requirements of FDAAA Section 801 and EU
- Recognize challenges of regulators, academia, industry in clinical trial disclosure
- Understand impact of noncompliance on the organization
Barbara Godlew, President, The Faire Company, LLC
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303: The Dynamics of Cooperative Groups Providing Coverage Analysis: How to Utilize the Information and Make it Work for You!
- Review rules and understand the complex issues with some Cooperative Group studies.
- Results from SWOG survey and the needs of members participating in research studies
- How to make a prepared CA work within your operations and how to work it locally
Kelly Willenburg, President, Synergism, LLC
Kati Stoermer
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| 4:15 – 4:30 pm |
Networking Break |
GENERAL SESSION 2
4:30 – 5:30 pm |
GS2
Lewis Morris (invited), Deputy Inspector General and Chief Counsel, Office of Inspector General, Department of Health and Human Services
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| 5:30 – 6:30 pm |
Networking Reception |
| Tuesday, June 5 |
| 7:15 am – 4:30 pm |
Registration |
| 7:15 – 8:30 am |
Continental Breakfast |
GENERAL SESSION 3
8:30 – 10:00 am |
TBD
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| 10:00 – 10:30 am |
Networking Break |
Breakout Sessions
10:30 am – 12:00 pm |
401: Privacy Complexities in Research Compliance
- Research subjects and privacy: What are the rules?
- Where is your research data or perhaps where isn't your research data.
- Practical solutions to protect the privacy & security of research subjects' information
Marti Arvin, Chief Compliance Officer, UCLA Health System
Mary Thomason, Privacy Compliance Consultant, Intermountain Healthcare
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402:
Fair Market Value Issues in Financial Arrangements with Research Physicians
- Fraud and Abuse laws that apply to research compensation arrangements
- How to construct compliant compensation arrangements with research physicians
- Recent cases and settlements
Robert Wade, Partner, Krieg DeVault
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403: BioSpecimen/Data
Kirk Nahra, J.D., CIPP, Partner, Wiley Rein LLP
Rachel Nosowsky, Principal Counsel, University of California
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| 12:00 – 1:00 pm |
Networking Lunch |
| 1:00 – 1:15 pm |
Break |
Breakout Sessions
1:15 – 2:45 pm |
501:
Successful FDA Inspections: How to Prevent and Respond to Common FDA Observations in a Form 483 or Warning Letter
- Identify the top 10 issues that are likely to result in a Warning Letter
- Discuss strategies for preventing FDA from issuing an FDA Form 483 or Warning Letter to you
- Know how to respond if you are issued an FDA Form 483 or Warning Letter
Richelle Little, JD, Regulatory Counsel, Western Institutional Review Board
Kara Morgenstern, Associate General Counsel, University of Michigan
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502: Creating Infrastructure Support for Sponsor-Investigators in Academic Health Centers
- Presentation of some of the common oversights by sponsor-investigators
- Overview of sponsor-investigator responsibilities under FDA regulation
- Description of Program to educate sponsor-investigators & promote compliance with FDA regulations
Keren Dunn, Manager, Research Compliance and Quality Improvement, Cedars-Sinai Medical Center
Karen Hartman, Operations Manager, Mayo Clinic
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503: Effective Financial Research Compliance Management
- Cover the key elements to financial compliance and managing the layers of complexity
- Discuss the application of regulatory requirements for a successful audit
- Discuss opportunities & approaches for ensuring financial compliance and assessing current practices
Kathryn Seifert, Consultant, Ernst & Young
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| 2:45 – 3:15 pm |
Networking Break |
GENERAL SESSION 4
3:15 – 4:30 pm |
Why Smart Leaders Do Dumb Things
Patrick Kuhse, Speaker, Speaking of Ethics
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| Wenesday, June 6 — Post-Conference |
| 7:30 – 11:30 am |
Registration |
| 7:30 – 8:30 am |
Networking Break |
Breakout Sessions
8:30 – 11:30 am |
W1:
Developing and Implementing a Research Compliance Audit Plan
- Establishing baseline based on government areas of focus and institutional priorities
- Exercise: Identifying and prioritizing research risks
- Case studies for addressing areas of indentified risks and control weakness
Jodi Ogden, Executive Director, Sponsored Projects Administration, UT Health, The University of Texas Health Science Center at Houston
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W2:
Recent Developments in Clinical Trial Regulation and Oversite
- Hear the latest information about new and proposed changes in regulatory oversight.
- Find out how the changes will affect the conduct of your studies.
- Get ideas on processes changes that might help you comply with the changes.
Cynthia Gates, RN, JD, CIP, VP Education and Consulting, Western IRB
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| 1:00 – 3:00 pm |
CCEP Exam |
Program | Hotel/City | Certification | Exhibit/Sponsor | Registration |
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