ExL Pharma's Clinical Research Compliance Conference Brochure
Upcoming SlideShare
Loading in...5
×
 

ExL Pharma's Clinical Research Compliance Conference Brochure

on

  • 1,363 views

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 & ...

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

Statistics

Views

Total Views
1,363
Views on SlideShare
1,363
Embed Views
0

Actions

Likes
0
Downloads
10
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

ExL Pharma's Clinical Research Compliance Conference Brochure ExL Pharma's Clinical Research Compliance Conference Brochure Document Transcript

  • 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
  • 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
  • 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 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 To Register Call 866-207-6528 or visit www.exlpharma.com/researchcompliance
  • 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
  • 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 555 8th Avenue, Suite 310 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
  • 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! q Amex q Discover Presents Exp. Date: Make checks payable to ExL Events, Inc. CliniCal CliniCal PLEASE MENTION PRIORITY CODE: P237 q Credit Card q Visa ReseaRCh ReseaRCh 555 8th Avenue, Suite 310 q MasterCard New York, NY 10018 ComplianCe summit ComplianCe summit q Check Take a ChanCe aT The annual CRC SummiT in laS VegaS METHOD OF PAYMENT: October 14-15, 2010 • The Palazzo Resort - Hotel - Casino • LAS VEGAS, NV Name on Card: Card Number: CARD TYPE: Keynote Presentation: Chaired By: Signature: Partnerships in Clinical Research: The Kelly Willenberg, Whole 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 A dditional Speaker E xamine And Discuss 866-207-6528 888-221-6750 Zip: Participation From The Pressing Issues and Learn Best q I wish to receive email updates on Exl Pharma’s upcoming events Practices in the following areas: Following Organizations: www.exlpharma.com/ researchcompliance • Health Information Management Alvin J. Siteman University of Arizona q I’m interested in marketing opportunities at this event including Security, Privacy and HITECH Cancer Center College of Medicine Children’s University of Medicine • Budget, Billing and Finance State: Fax: Main Conference and Workshop Medical Center and Dentistry, New Jersey • Fraud & Abuse Compliance Concepts University of California • Regulatory, Legal and q Register me for the Main Conference GE Healthcare University Hospitals Government Enforcement 555 8th Avenue, Suite 310 Systems Case Medical Center • Healthcare Reform Palmetto Health WellSpan Health New York, NY 10018 • Ethics and Voluntary Disclosures PLUS! A HALF DAY WORKSHOP ON ExL Events, Inc. To Register: Regulatory, Legal and Government Enforcement: Please contact me: The Latest Trends! Telephone: Company: Yes! Address: Register at Sponsored By: Name: Dept.: Email: Title: City: q www.exlpharma.com/researchcompliance