October 14-15, 2010 • The Palazzo Resort - Hotel - Casino • LAS VEGAS, NV

Chaired By:Kelly Willenberg, President, SYNERGISM, LLC

Keynote Presentation:Partnerships in Clinical Research: The Whole is Greater Than the Sum of its PartsStephanie J. Zafonte, MSN, RN, CCRP, CQA, RAC Nurse, Consultant, Clinical Product Manager, EHDB, DMID, NIAID, NATIONAL INSTITUTE OF HEALTH

Examine And Discuss PressingIssues and Learn Best Practices inthe following areas:• Health Information Management including

Security, Privacy and HITECH• Budget, Billing and Finance• Fraud & Abuse• Regulatory, Legal and

Government Enforcement• Healthcare Reform• Ethics and Voluntary Disclosures

Take a ChanCe aT The annual CRC SummiT in laS VegaS

CLINICALReseARChCompLIANCe summIt

PLUS! A HALF DAYWORKSHOP ON

Register by September 3rd for the Best Savings!

The Only Fall Event to Bring together Research Sites, Hospitals, Sponsors and CROs to Discuss Research Compliance Best Practices

Presents

Additional Speaker Participation From The Following Organizations:Alvin J. Siteman Cancer Center

Children’s Medical Center

Compliance Concepts

GE Healthcare Systems

Palmetto Health

University of Arizona College of MedicineUniversity of Medicine and Dentistry, New JerseyUniversity of CaliforniaUniversity Hospitals Case Medical CenterWellSpan Health

Regulatory, Legal and Government Enforcement: The Latest Trends!

Register at www.exlpharma.com/researchcompliance

Sponsored By:

To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

CliniCal ReseaRCh ComplianCe summit

Dear Colleague:Welcome to the first Research Compliance Best Practice Summit!

In response to requests to provide a conference on research healthcare compliance, the Annual Clinical Research Compliance 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.

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!

Sincerely,

Kelly M. Willenberg President, SYNERGISM, LLC

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.

Compliance•Ethics•Clinical Research•Billing•Finance •Legal •Clinical Trials•

Regulatory•Compliance Officers•Auditors•General Counsel•CFOs•Research Coordinators •IRB Members•

Who Should Attend? Hospital, Healthcare and Academic Research Institution

Executives with the following titles:

Secondary/Tertiary Market

Clinical Billing Systems•Law Firms•Healthcare Consultants•Clinical Trial Management System•

Pharmaceutical, Biotech & Medical Device Executives with the following responsibilities in the following areas:

Clinical Trial Operations•Clinical Research Operations•Contracts•Billing•Health Economics•

Clinical Finance•Ethics•Compliance•Legal/Corporate Counsel•Medical Programs•

WelcomeThe Only Event to Bring together Clinical Trial Sponsor, Governmental

Agencies and Research Sites to Discuss Research Compliance Best Practices

PS: Interested in continiung education credit? Please e-mail info@exlpharma.com to find out what certifications are available by attending this event

2009Audience Breakdown

at Past Research Compliance Programs:

53%

30%

14%

3%

To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

Sponsorship and Exhibition Opportunities: Maximize Your Marketing EffortsIncrease your company’s direct exposure to targeted audiences by partnering with ExL. We provide unique, valuable forums that display your products, highlight your services and illustrate your expertise. ExL events are designed to help your company forge new partnerships with potential clients. To obtain more information about the accretive value in partnering with ExL, please contact:

Lucas Carrasco, Business Development Manager 212-400-6232 | Lcarrasco@exlpharma.com

9:00 Regulatory, Legal and Government Enforcement: The Latest Trends

• The shifting tide in healthcare in billing and regulatory• 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 CALIfORnIAPanelist:Sonia Kleiner-Arje, CHRC, Executive Director, Office of Clinical Research Administration, UnIvERSITY Of MEDICInE AnD DEnTISTRY, nEw JERSEYBrian C. Springer, MHA , Executive Director Research and Business Administration, ALvIn J. SITEMAn CAnCER CEnTERBarry Rosen, JD, CHC, CHRC, Manager, Regulatory Compliance, CHILDREn’S MEDICAL CEnTER

12:00 workshop concludes | Luncheon for workshop attendees

1:15 Chairperson’s welcome Kelly Willenberg

President SYnERGISM, LLC

KEYnOTE SESSIOn1:30 Partnerships in Clinical Research: Government, Academia and

Private Industry, the whole is Greater Than the Sum of Its Parts • Who is the National Institute of Health (NIH)?• Describe the government’s role in the biomedical research industry• Explore the public-private partnerships in dealing with specific

issues such as funding and clinical monitoring• Describe the role of data safety monitoring plans in relationship to

IRBs and DSMBsStephanie J. Zafonte MSN, RN, CCRP, CQA, RAC Nurse Consultant/Clinical Project Manager, EHDB, DMID, NIAID, nATIOnAL InSTITUTE Of HEALTH

2:15 Practical Solutions for HIPAA in Clinical Research• Update on the new rules that apply when transitioning to

Protected Health Information (PHI) for research purposes • Learn how to avoid the severe consequences when

non-authorized disclosures are made • In-depth focus on three practical mechanisms for research

sites and individual practices that can help providers be HIPAA 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

3:00 Mid-Afternoon Refreshment & networking Break

3:30 Ten ways to Meet face to face with OIG on voluntary Disclosures in Clinical Research• What would lead your institution to a voluntary disclosure? • Identifying that a voluntary disclosure may be needed • 3-step process to a voluntary disclosure• Action plan for the futurePat Marion, CFE, Principal, COMPLIAnCE COnCEPTS, InC.

4:15 Biospecimens and Ethics – How Are Biospecimen’s Important To A Clinical Trial Or Basic Research Investigation? • What are the steps that are necessary to ensure compliance?• The ethical issues surrounding the use of human tissue are similar

to those that arise in relation to other research involving humans• IRB Review and Human Subject Protection when biospecimens

are involved • Define the importance of a biospecimen Dr. Joan Rankin Shapiro, Associate Dean for Research and Research Professor, Basic Medical Sciences; UnIvERSITY Of ARIZOnA COLLEGE Of MEDICInE

5:00 Day One Concludes

Day One October 14th, 2010

MAIN CONfERENCE BEGINS

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To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

8:30 Chairperson’s Recap of Day One

8:45 Effectively Bridging Business and Clinical Operations in Research with Integrated IT Solutions• Why do you need to consider IT solutions to your business

problems?• How do you leverage the billing piece with the clinical operations? • What does it mean to compliance? Kelly M. Willenberg, President, SYnERGISM, LLC. A Representative from GE HEALTHCARE IT SOLUTIOnS

9:30 The Un-Monkey wrench: Maintaining the Trajectory in Research Centers when the Economy Tanks• Review of metrics and deliverables for research centers --

specific examples from the NCI (Comprehensive) Cancer Centers, Community Cancer Centers, and CTSAs

• Impact of economic hard times• Strategies used by centers to address the economy and maintain a

strong trajectoryBrian C. Springer, MHA, Executive Director Research and Business Administration, ALvIn J. SITEMAn CAnCER CEnTER

10:15 Mid-Morning Refreshment & networking Break

10:45 Research Compliance Plan Audit Checklist: How To Do More with Less• Example of a work plan tool• How to leverage other hospital departments into an effective

compliance plan• How to make your compliance audit plan work for you! • Tips for selling the planBarry Rosen, JD, ARM, CHC, CHRC, Manager, Regulatory Compliance, CHILDREn’S MEDICAL CEnTER

11:30 Solving the Issues and Challenges of Establishing Comprehensive Clinical Trial Management and Research Billing Compliance in a Large Research Institution• Deploying the Necessary Organizational Processes and Tools• How do you establish organizational breakthroughs in education

and communication in billing compliance?• How do you use a leading-edge clinical trials management software

system to enable a new, central clinical research infrastructure?• How do you implementation of an enterprise-wide system of

financial responsibility?Katherine Hammerhofer, RN, Director for the Center of Clinical Research and Technology, UnIvERSITY HOSPITALS CASE MEDICAL CEnTER

12:15 Luncheon for Conference Attendees

1:30 Create a Communication flow and Hierarchy with Pharmaceutical Sponsors• Learn how to work best in research initiatives from the sponsor’s

perspective • Create a communication flow and a hierarchy• How to negotiate budgets effectively• Be prompt in communicating to enhance research effectiveness• Delineate the roles to determine workflow best practicesStephanie J. Zafonte, MSN, RN, CCRP, CQA, RAC Nurse, Consultant, Clinical Producet Manager, EHDB, DMID, NIAID nATIOnAL InSTITUTE Of HEALTHSonia Kleiner-Arje, CHRC, Executive Director, Office of Clinical Research Administration, UnIvERSITY Of MEDICInE AnD DEnTISTRY, nEw JERSEY

2:30 facilitating Clinical Research Relationships with Investigators• Implement good policies with rewards• Build effective two-way communication• Enhance customer service operations• Learn to see things from their perspectiveLinda Sherriff, BSN, MHA, CCRC, Clinical Trials, Manager, PALMETTO HEALTH

3:15 BREAKOUT ROUnDTABLE TOPICS - SUBMIT YOUR TOPIC PROPOSAL!This portion of the schedule has been set aside for breakout ses-sions and all Summit participants are welcome to submit session proposals. Choose from a wide variety of in-depth breakout sessions designed to stretch your minds and improve your skill sets. Glean invaluable insights from peers and colleagues from around the globe on ways to reduce costs and improve efficiency. Breakout Sessions will be limited to 45 minutes, including Q&A

fInAnCE SECTIOn:

• Grants Management in a Complex Environment• Budget Justification• Monitoring Billing in Research

DEvICE SECTIOn:

• Trends• Reimbursement

LEGAL AnD InTELLECTUAL PROPERTY SECTIOn

• Latest Trends• Regulations Impacting Clinical Trials• Conflicts of Interest – Relations with Industry

5:00 Conference Concludes

Day Two October 15th, 2010 MAIN CONfERENCE CONTINuES

5

To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance

fees and Payments for attending the Clinical Research Compliance Summit Early-Bird Regular Before 9/3 After 9/3

* Academic/non-Profit/Government Rate: Main Conference $1095 $1295Main Conference, plus Workshop $1295 $1495

Corporate Rate: Main Conference $1695 $1895Main Conference, plus Workshop $1995 $2095

* Only applies to full-time academic organizations and hospital organizations of non-profit status or full-time government agencies. Does not apply to government contractors.

CONFERENCE & MEDIA PARTNERS

Five Ways to Register:Mail: ExL Events, Inc. 555 8th Avenue, Suite 310 New York, NY 10018Phone: 866-207-6528Fax: 888-221-6750Email: register@exlpharma.com

Online: www.exlpharma.com/healthcarecompliance

Group Discount Program:

For every three simultaneous registrations from your company, you will receive a fourth complimentary registration. If you are sending only three, you can earn a 15% discount off the price of those registrations. To take advantage, please register online, or call 866-207-6750.Make checks payable to ExL Events, Inc. and write code P237 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received by October 7th , 2010

Cancellations:

If you need to cancel your registration for the upcoming conference, please note the following policies derived from the start date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.One to Four weeks: A 50% refund, or a voucher to another ExL event valid for two years from the voucher issue date.Within the Last Week: A voucher to another ExL event valid for two years from the voucher issue date.To receive a refund or voucher, please fax your request to 888-221-6750.

PLEASE NOTE: Speakers, agenda and venue are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.

Register by September 3rd, 2010 to take advantage of our Early-Bird Pricing

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!

Meet, Learnv Network

with Clinical Trial Sponsor, Governmental Agencies and Research Sites

October 14-15, 2010 • The Palazzo Resort - Hotel - Casino • LAS VEGAS, NV

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at www.exlpharma.com/researchcompliance

Sponsored By:

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To Register:ExL Events, Inc. 555 8th Avenue, Suite 310 New York, NY 10018

www.exlpharma.com/ researchcompliance

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