In response to requests to provide a conference on research healthcare compliance, the Inaugural ExL Pharma Research Compliance Best Practice Summit is making a grand appearance at The Palazzo Hotel & Casino in October. Taking all major areas in research compliance, from fraud and abuse to billing compliance, our goal is to provide quality speakers for a great conference in a fantastic location. Thought leaders from across the country will present case studies and share best practices from many industry sectors including leading employers, health system and hospital providers, pharmaceutical executives, academics, analysts and government officials. ExL Pharma is pleased to announce the inaugural Research Compliance Best Practice Summit. This event is unique in that it brings together executives to discuss how to enhance operational effectiveness and increase compliance initiatives, especially in the wake of the healthcare reform. The program features perspectives from industry thought leaders and provides you with the opportunity to learn and implement current strategies to improve your clinical research efforts. Join us October 14-15th, 2010 in Las Vegas for an exciting event! For more information, please visit: http://www.exlpharma.com/events/healthcare-research-compliance-summit

1. The Only Fall Event to Bring together Research Sites, Hospitals, Sponsors Register by September 3rd
and CROs to Discuss Research Compliance Best Practices for the Best Savings!
Presents
CLINICAL
ReseARCh
CompLIANCe summIt
Take a ChanCe aT The annual CRC SummiT in laS VegaS
October 14-15, 2010 • The Palazzo Resort - Hotel - Casino • LAS VEGAS, NV
Keynote Presentation: Chaired By:
Partnerships in Clinical Research: The Whole
Kelly Willenberg,
is Greater Than the Sum of its Parts
President,
Stephanie J. Zafonte, MSN, RN, CCRP, CQA, RAC Nurse, SYNERGISM, LLC
Consultant, Clinical Product Manager, EHDB, DMID, NIAID,
NATIONAL INSTITUTE OF HEALTH
Additional Speaker Participation Examine And Discuss Pressing
From The Following Organizations: Issues and Learn Best Practices in
Alvin J. Siteman University of Arizona the following areas:
Cancer Center College of Medicine • Health Information Management including
University of Medicine
Children’s Medical Center and Dentistry, New Jersey Security, Privacy and HITECH
Compliance Concepts University of California • Budget, Billing and Finance
GE Healthcare Systems University Hospitals • Fraud & Abuse
Case Medical Center
Palmetto Health • Regulatory, Legal and
WellSpan Health
Government Enforcement
PLUS! A HALF DAY • Healthcare Reform
• Ethics and Voluntary Disclosures
WORKSHOP ON
Regulatory, Legal and Government Enforcement:
The Latest Trends!
Sponsored By:
Register at
www.exlpharma.com/researchcompliance

2. CliniCal ReseaRCh
Welcome ComplianCe summit
The Only Event to Bring together Clinical Trial Sponsor, Governmental
Agencies and Research Sites to Discuss Research Compliance Best Practices
Dear Colleague:
Welcome to the first Research Compliance Best Practice Summit!
Who Should Attend?
Hospital, Healthcare and Academic Research Institution
In response to requests to provide a conference on research healthcare Executives with the following titles:
compliance, the Annual Clinical Research Compliance Summit is • Compliance • Regulatory
making a grand appearance at The Palazzo Hotel & Casino in October. • Ethics • Compliance Officers
Taking all major areas in research compliance, from fraud and abuse • Clinical Research • Auditors
to billing compliance, our goal is to provide quality speakers for a great
• Billing • General Counsel
conference in a fantastic location. Thought leaders from across the country
• Finance • CFOs
will present case studies and share best practices from many industry
sectors including leading employers, health system and hospital providers, • Legal • Research Coordinators
pharmaceutical executives, academics, analysts and government officials. • Clinical Trials • IRB Members
This event is unique in that it brings together executives to discuss how to
Pharmaceutical, Biotech & Medical Device Executives
enhance operational effectiveness and increase compliance initiatives, especially
with the following responsibilities in the following areas:
in the wake of the healthcare reform. The program features perspectives from
industry thought leaders and provides you with the opportunity to learn and • Clinical Trial Operations • Clinical Finance
implement current strategies to improve your clinical research efforts. Join us • Clinical Research Operations • Ethics
October 14-15th, 2010 in Las Vegas for an exciting event! • Contracts • Compliance
Sincerely, • Billing • Legal/Corporate Counsel
• Health Economics • Medical Programs
Secondary/Tertiary Market
• Clinical Billing Systems
Kelly M. Willenberg
• Law Firms
President, SYNERGISM, LLC
• Healthcare Consultants
PS: Interested in continiung education credit? Please e-mail info@exlpharma.com • Clinical Trial Management System
to find out what certifications are available by attending this event
2009
30%
Audience Breakdown
53%
at Past Research
14%
Compliance Programs:
3%
The Palazzo Resort~Hotel~Casino 3325 Las Vegas Boulevard South, Las Vegas, Nevada 89109
Venetian Palazzo Meetings isn’t just the world’s most luxurious five-diamond hotel, or the top meeting facility of its kind, it’s a full resort destination designed exclusively
for the business traveler. Every detail has been perfected to assure that you not only experience a successful business venture, but also have the time of your life. With The
Grand Canal Shoppes, you needn’t travel to New York or Milan to find thwe most exclusive retail stores in the world. Be transported to quaint streets of Venice, among arched
bridges, and of course, the sparkling Grand Canal where gondoliers serenade their passengers. The adrenaline rush of our casino, or a body cocoon at the Canyon Ranch
SpaClub®—you decide. Steps away, explore attractions, golf courses, and nightlife. This is Las Vegas at its best.
Reservations must be made before Monday, September 20th by calling 866-659-9659. Requests received after the reservation cut-off date may
be accepted on a space available basis at the hotels prevailing rate.
To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

3. Day One October 14th, 2010
9:00 Regulatory, Legal and Government Enforcement: The Latest Trends
• The shifting tide in healthcare in billing and regulatory
Pre ConferenCe
WorkshoP ½ day
• Liability risks in clinical trials
• FDA expectations in 2011
• The Fraud Enforcement and Recovery Act of 2009: understanding how the False Claims Act Amendments
will impact Qui Tams in the regulatory area
• Litigation update in clinical trials
Panel Moderator:
Rachel Nosowsky, JD, Principal Counsel, UnIvERSITY Of CALIfORnIA
Panelist:
Sonia Kleiner-Arje, CHRC, Executive Director, Office of Clinical Research Administration,
UnIvERSITY Of MEDICInE AnD DEnTISTRY, nEw JERSEY
Brian C. Springer, MHA, Executive Director Research and Business Administration, ALvIn J. SITEMAn CAnCER CEnTER
Barry Rosen, JD, CHC, CHRC, Manager, Regulatory Compliance, CHILDREn’S MEDICAL CEnTER
12:00 workshop concludes | Luncheon for workshop attendees
MAIN CONfERENCE BEGINS
1:15 Chairperson’s welcome 3:00 Mid-Afternoon Refreshment & networking Break
Kelly Willenberg
President 3:30 Ten ways to Meet face to face with OIG on voluntary
SYnERGISM, LLC Disclosures in Clinical Research
KEYnOTE SESSIOn • What would lead your institution to a voluntary disclosure?
1:30 Partnerships in Clinical Research: Government, Academia and • Identifying that a voluntary disclosure may be needed
Private Industry, the whole is Greater Than the Sum of Its Parts • 3-step process to a voluntary disclosure
• Who is the National Institute of Health (NIH)? • Action plan for the future
• Describe the government’s role in the biomedical research industry Pat Marion, CFE, Principal, COMPLIAnCE COnCEPTS, InC.
• Explore the public-private partnerships in dealing with specific
issues such as funding and clinical monitoring 4:15 Biospecimens and Ethics – How Are Biospecimen’s Important
• Describe the role of data safety monitoring plans in relationship to To A Clinical Trial Or Basic Research Investigation?
IRBs and DSMBs • What are the steps that are necessary to ensure compliance?
Stephanie J. Zafonte MSN, RN, CCRP, CQA, RAC Nurse • The ethical issues surrounding the use of human tissue are similar
Consultant/Clinical Project Manager, EHDB, DMID, NIAID, to those that arise in relation to other research involving humans
nATIOnAL InSTITUTE Of HEALTH • IRB Review and Human Subject Protection when biospecimens
2:15 Practical Solutions for HIPAA in Clinical Research are involved
• Update on the new rules that apply when transitioning to • Define the importance of a biospecimen
Protected Health Information (PHI) for research purposes Dr. Joan Rankin Shapiro, Associate Dean for Research
• Learn how to avoid the severe consequences when and Research Professor, Basic Medical Sciences;
non-authorized disclosures are made UnIvERSITY Of ARIZOnA COLLEGE Of MEDICInE
• In-depth focus on three practical mechanisms for research
sites and individual practices that can help providers be HIPAA
5:00 Day One Concludes
compliant as they endeavor to conduct health care research
• De-identifying data via independent broker and electronically
• Protecting data by using virtual PCs”
Christy Gilchrist, PhD, CRA; Director of Research;
wELLSPAn HEALTH
Sponsorship and Exhibition Opportunities: Maximize Your Marketing Efforts
Increase your company’s direct exposure to targeted audiences by partnering with ExL.We provide unique, valuable forums that display your products, highlight
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To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

4. Day Two October 15th, 2010
MAIN CONfERENCE CONTINuES
8:30 Chairperson’s Recap of Day One 1:30 Create a Communication flow and Hierarchy with
Pharmaceutical Sponsors
8:45 Effectively Bridging Business and Clinical Operations in
Research with Integrated IT Solutions • Learn how to work best in research initiatives from the sponsor’s
perspective
• Why do you need to consider IT solutions to your business
problems? • Create a communication flow and a hierarchy
• How do you leverage the billing piece with the clinical operations? • How to negotiate budgets effectively
• What does it mean to compliance? • Be prompt in communicating to enhance research effectiveness
Kelly M. Willenberg, President, SYnERGISM, LLC. • Delineate the roles to determine workflow best practices
A Representative from GE HEALTHCARE IT SOLUTIOnS Stephanie J. Zafonte, MSN, RN, CCRP, CQA, RAC Nurse,
Consultant, Clinical Producet Manager, EHDB, DMID, NIAID
9:30 The Un-Monkey wrench: Maintaining the Trajectory in nATIOnAL InSTITUTE Of HEALTH
Research Centers when the Economy Tanks
Sonia Kleiner-Arje, CHRC, Executive Director, Office of Clinical
• Review of metrics and deliverables for research centers -- Research Administration, UnIvERSITY Of MEDICInE AnD DEnTISTRY,
specific examples from the NCI (Comprehensive) Cancer nEw JERSEY
Centers, Community Cancer Centers, and CTSAs
• Impact of economic hard times 2:30 facilitating Clinical Research Relationships with Investigators
• Implement good policies with rewards
• Strategies used by centers to address the economy and maintain a
strong trajectory • Build effective two-way communication
Brian C. Springer, MHA, Executive Director Research • Enhance customer service operations
and Business Administration, ALvIn J. SITEMAn CAnCER CEnTER • Learn to see things from their perspective
Linda Sherriff, BSN, MHA, CCRC, Clinical Trials, Manager,
10:15 Mid-Morning Refreshment & networking Break PALMETTO HEALTH
3:15 BREAKOUT ROUnDTABLE TOPICS - SUBMIT YOUR TOPIC PROPOSAL!
10:45 Research Compliance Plan Audit Checklist: How To Do More This portion of the schedule has been set aside for breakout ses-
with Less sions and all Summit participants are welcome to submit session
• Example of a work plan tool proposals. Choose from a wide variety of in-depth breakout sessions
• How to leverage other hospital departments into an effective designed to stretch your minds and improve your skill sets. Glean
compliance plan invaluable insights from peers and colleagues from around the globe
• How to make your compliance audit plan work for you! on ways to reduce costs and improve efficiency.
• Tips for selling the plan Breakout Sessions will be limited to 45 minutes, including Q&A
Barry Rosen, JD, ARM, CHC, CHRC, fInAnCE SECTIOn:
Manager, Regulatory Compliance, CHILDREn’S MEDICAL CEnTER
• Grants Management in a Complex Environment
11:30 Solving the Issues and Challenges of Establishing • Budget Justification
Comprehensive Clinical Trial Management and Research Billing • Monitoring Billing in Research
Compliance in a Large Research Institution
• Deploying the Necessary Organizational Processes and Tools DEvICE SECTIOn:
• How do you establish organizational breakthroughs in education • Trends
and communication in billing compliance? • Reimbursement
• How do you use a leading-edge clinical trials management software LEGAL AnD InTELLECTUAL PROPERTY SECTIOn
system to enable a new, central clinical research infrastructure?
• Latest Trends
• How do you implementation of an enterprise-wide system of
financial responsibility? • Regulations Impacting Clinical Trials
Katherine Hammerhofer, RN, • Conflicts of Interest – Relations with Industry
Director for the Center of Clinical Research and Technology,
UnIvERSITY HOSPITALS CASE MEDICAL CEnTER 5:00 Conference Concludes
12:15 Luncheon for Conference Attendees
To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

5. CONFERENCE Meet, Learn
& MEDIA PARTNERS v Network
with Clinical Trial Sponsor,
Governmental Agencies and Research Sites
The Clinical Research Compliance Summit is a unique
gathering of key senior-level officers and executives from the University of California,
Children’s Medical Center, WellSpan, Alvin J. Siteman Cancer Center, University of
Arizona, UMDNJ, Palmetto Health and the NIH. At no other event will you have
the ability to interact with so many leaders that are driving research compliance.
This Summit provides many opportunities for you to interact with peers “off-line,”
make business connections and build new relationships. Here are just a few of the
networking opportunities available:
Keynote Speeches Interactive Roundtable Sessions
Ample Networking Breaks Networking Luncheon
Evening Reception And Much More!
Five Ways to Register: Group Discount Program:
5
Mail: ExL Events, Inc. For every three simultaneous registrations from your company, you will
receive a fourth complimentary registration. If you are sending only
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three, you can earn a 15% discount off the price of those registrations.
New York, NY 10018 To take advantage, please register online, or call 866-207-6750.
Phone: 866-207-6528 Make checks payable to ExL Events, Inc. and write code P237 on
Fax: 888-221-6750 your check. You may also use Visa, MasterCard, Discover or American
Email: register@exlpharma.com Express. Payments must be received by October 7th , 2010
Online: www.exlpharma.com/healthcarecompliance
Cancellations:
If you need to cancel your registration for the upcoming conference,
fees and Payments for attending the please note the following policies derived from the start date of the
Clinical Research Compliance Summit event:
Four weeks or more: A full refund (minus a $95 processing fee), or
Register by September 3rd, 2010 to take Early-Bird Regular a voucher to another ExL event valid for two years from the voucher
advantage of our Early-Bird Pricing Before 9/3 After 9/3 issue date.
One to Four weeks: A 50% refund, or a voucher to another ExL event
* Academic/non-Profit/Government Rate:
valid for two years from the voucher issue date.
Main Conference $1095 $1295
Within the Last Week: A voucher to another ExL event valid for two
Main Conference, plus Workshop $1295 $1495 years from the voucher issue date.
Corporate Rate: To receive a refund or voucher, please fax your request to
Main Conference $1695 $1895 888-221-6750.
Main Conference, plus Workshop $1995 $2095
* Only applies to full-time academic organizations and hospital organizations PLEASE NOTE:
of non-profit status or full-time government agencies. Does not apply to Speakers, agenda and venue are subject to change without notice.
government contractors. In the event of a speaker cancellation, every effort to find a suitable
replacement will be made.
To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

6. The Only Fall Event to Bring together Research Sites, Hospitals, Sponsors Register by September 3 rd
and CROs to Discuss Research Compliance Best Practices for the Best Savings!
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Partnerships in Clinical Research: The
Kelly Willenberg,
Whole is Greater Than the Sum of its Parts
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SYNERGISM, LLC
Consultant, Clinical Product Manager, EHDB, DMID,
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