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February 5 – 7, 2014 Washington, DC
www.DisclosureSummit.com
GolD Grantor:
Bronze GrantorS:
SponSor:
Silver Grantor:
Disclosure, transparency and aggregate Spend for Drug, Device and Biotech Companies
Sixth annual Summit on
A Hybrid Conference & Internet
Event See page 2
SPECIAL PCF REGISTRATION DISCOUNT See page 7 for Special pharmaceutical Compliance association member registration Discount.
Margaret K. Feltz, Esq., Director, Corporate Compliance, Purdue Pharma LP; Executive Committee, Pharmaceutical Compliance Forum
Ashish Kalgaonkar, RPh, MBA, Senior Director, Global HCP Transparency Reporting, Eli Lilly and Company
Summit Co ChairS:
Hyatt Regency Crystal City
Douglas Brown, MHS, Deputy Director, Data Sharing and Partnership Group (DSPG), Center for Program Integrity, Centers for Medicare and Medicaid Services
Margaret (Peg) Hutchinson, Esq., Assistant US Attorney, Civil Division, United States Attorney’s Office, Eastern District of Pennsylvania
Roann Nichols, Esq., Assistant US Attorney, United States Attorney’s Office, District of Maryland
KeYnote SpeaKerS:
Trudy J. Seeley, Senior Manager, Transparency Operations, Sanofi US
Robert Patten, Esq., Assistant Attorney General, Medicaid Fraud Division, The Commonwealth of Massachusetts; Co-chair, Global Case Committee, National Association of Medicaid Fraud Control Units
meDia partnerS:
CONTINUING EDUCATION CREDITSCOMPLIANCE PROFESSIONALS: Up to 23.4 Live CCB CEUs
ACCOUNTING PROFESSIONALS: Up to 24 NASBA CPE credits
ATTORNEyS: The Summit is currently pending approval to offer California, Pennsylvania and Texas MCLE Credit.
Domestically pharma and device companies are in the heart of their efforts to meet the march 2014 reporting date mandated by the physician payments Sunshine act. the Summit offers the following sessions focused on crucial short-term issues related to sunshine reporting and compliance and the challenges that are likely to arise thereafter:
• March31stFilingDeadline:TheTopSixStepstoPrepare• AssumptionsandCompletingContextBoxes:ToDoorNottoDo;ThatistheQuestion• ManagingtheDisputeResolutionProcess• CoordinationofComplianceamongMultipleAffiliates• TransactionReviewsforNon-CIAOrganizations• ProtectingReputationandRelationshipswithPhysiciansandTeachingHospitals• DisclosureFairMarketValueDeterminations• InteractionandCoordinationbetweenStateandFederalReportingRequirements• AnticipatedStateandFederalEnforcementInitiatives• WillSunshineDatahelpWhistleBlowersandQuiTamAttorneys?
Concurrently, national regulatory regimes and voluntary code guidelines regulating the disclosure of hCp spendarerapidlyproliferatingacrosstheglobe.NationalinitiativesexistorarebeingrolledoutinFrance,portugal, Denmark, estonia, hungary, russia, Slovakia, Spain and ukraine. voluntary codes are in place in the CzechRepublic,Germany,Greece,Italy,theNetherlands,Spain,TurkeyandUK(ABPI).OnJune24,2013,theEuropeanFederationofPharmaceuticalIndustriesandAssociations(“EFPIA”)adoptedanewcode,“EFPIACodeonDisclosureofTransfersofValueFromPharmaceuticalCompaniestoHealthcareProfessionalsandHealthcareOrganisations”whichrequirespharmaceuticalcompaniestopubliclydisclose,in2016,their2015financialrelationswithhealthcareorganizationsandhealthcareprofessionals.InAsiaPacific,Australia(MedicinesAus-tralia)andJapan(JapanPharmaceuticalManufacturersAssociation(“JPMA”))guidelinesonTransparencyonCorporateActivitieswithMedicalInstitutionsandHealthcareProfessionals”(“JPMAGuidelines”)areexamplesof the trend towards transparency. these developments will be covered in detail.
TheSummitwillalsoprovideacomprehensiveupdateoftherapidlyevolvingtransparencyrequirementsnowtaking shape across the globe and offer timely advice on creating a global aggregate spend and disclosure program.In-houseexpertswillsharetheirexperienceonawidearrayofemergingbestpracticesrangingfromprojectmanagementtobuildingscalabilityandsustainability.Panelsofin-houseandoutsideexpertswillweigh in on key topics.
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partiCipation optionS traDitional onSite attenDanCeSimply register, travel to the conference city and attend in person.PROS:subjectmatterimmersion;professional networking opportunities;facultyinteraction.
Who ShoulD attenD:• AggregateSpendReporting• StateReporting• RegulatoryAffairs• BusinessAnalytics
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Onsite At your office . . . . . . or home
HOTElINFORMATION/RESERVATIONSTheHyattRegencyCrystalCityistheofficialhotel for the Sixth annual Summit on DiSCloSure, TRANSPARENCyANDAGGREGATESPENDFORDRUG,DeviCe anD BioteCh CompanieS. a special group rate of$219.00single/doublepernight(plustax)hasbeenarranged for Summit attendees.
Pleasegotohttp://www.disclosuresummit.com/travel.html for instructions on how to make your reservation and obtain the group rate:
reservations at the group rate will be accepted while rooms are available or until the cut-off date of Tuesday, January 14, 2014. after this, reservations will be ac-cepted on a space-available basis at the prevailing rate.
Hyatt Regency Crystal City at Reagan National Airport2799JeffersonDavisHighway arlington, va 22202
Tel:+1(703)4181234• Finance/Accounting/Audit• CommercialOperations• ClinicalOperations• MedicalAffairs
ABOUTTHEPHARMACEUTICAlCOMPlIANCEFORUMThePharmaceuticalComplianceForum(PCF)isacoalitionofseniorcompli-anceprofessionalsandlegalcounselfrommorethan50ofthelargestresearchbasedpharmaceuticalmanufacturers.ThePCFwasfoundedinearly-1999bycompliance professionals from the pharmaceutical industry to promote effective
corporate compliance programs. the members meet twice a year, for two days, focusing on open and informal sharingofcomplianceinformation,bestpractices,andcurrentdevelopmentsinthefield.PCFalsosponsorsathree-daycompliancecongresseachFall.Formembershipinformation,contactKellyFreemanviaemailat kbfreeman@lilly.com. please visit their website at www.PharmaComplianceForum.org.
• CorporateCommunications• IS/IT• EthicsandCompliance• legal
live anD arChiveD internet attenDanCeWatch the conference in live streaming video over the internet and at your convenience at any time 24/7forsixmonthsfollowingtheevent.the archived conference includes speaker videos and coordinated powerpoint presentations.PROS:livedigitalfeedand24/7Internetaccessforthenextsixmonths;accessibleintheoffice,athomeoranywhereworldwidewithInternetaccess;avoidtravelexpenseandhassle;notimeawayfromtheoffice. Co
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4:00 pm Assumptions and Completing Context Boxes: To Do or Not to Do; That is the Question• TheAgency’sstatedpurposeswithrespecttoassumptionsletters
and context boxes• TheprosandconsofsubmittinganassumptionslettertotheCenters
for Medicare and Medicaid Services• Strategiesfordocumentingassumptions• Creatinganinternalassumptionsdocument,whetherornotyour
company submits an assumptions letter to the Agency • Howtoeffectivelyusecontextboxestodocumenttransaction-level
information that could not otherwise be used in the transparency report
Meenakshi Datta, Esq., Partner, Sidley Austin LLP, Chicago, IL
Angela Fifelski, Esq., Corporate Counsel, Baxter, Deerfield, IL
4:30 pm Managing the Dispute Resolution Process• ReviewoftheSunshineRule’sMinimumRequirementsforDispute
Resolution• DiscussionofBestPracticesforEffectiveDisputeResolution
Management• AudienceBenchmarkingofDisputeResolutionProcedures
Julie Brubaker, Esq., Compliance Officer, Biomet Warsaw Operations; Former Deputy Solicitor General, Indiana Attorney General, Warsaw, IN
Margaret K. Feltz, Esq., Director, Corporate Compliance, Purdue Pharma LP; Executive Committee, Pharmaceutical Compliance Forum, Stamford, CT
Ronald L. Wisor, Jr. Esq., Partner, Hogan Lovells US LLP, Washington, DC
5:15 pm Technology Solutions: Panelists from Leading Technology Firms Provide Insights on Current and Future Trends in Aggregate Spend Technology• OverviewoftheCurrentLandscapeandTypesofSolutionsonthe
Market• TechnologistPerspectiveonwhatMakesaSuccessfulPartnership
• ViewsonBestPracticeApproachesbyClients• ReviewNewestFeaturesandPendingEnhancements
Michael D. Bell, Founder and President, R-Squared, Princeton, NJ
Susan Hill, Senior Vice President, Business Development, AHM, Philadelphia, PA
John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ
Dean Rossi, Founder and President, Alanda, New Brunswick, NJ
Don Soong, Vice President of Strategic Solutions, Cegedim Relationship Management, Richmond, VA
Jon Wilkenfeld, MBA, President, Potomac River Partners, Vienna, VA (Moderator)
6:15 pm Adjournment and Networking Reception
WEDNESDAy,FEBRUARy5,20147:00 am Registration Commences
DiSCloSure Summit DaY i openinG plenarY SeSSion — the SunShine aCt1:00 pm Welcome and Overview
Margaret K. Feltz, Esq., Director, Corporate Compliance, Purdue Pharma LP; Executive Committee, Pharmaceutical Compliance Forum, Stamford, CT (Co-chair)
THE US REGULATORy SETTING OVERVIEW
1:15 pm The Sunshine RegulationsDouglas Brown, MHS, Deputy Director, Data Sharing and Partnership Group (DSPG), Center for Program Integrity, Centers for Medicare and Medicaid Services, Baltimore, MD
2:00 pm Chief Compliance Officer Roundtable: How Disclosure/Transparency Compliance Fits into a Successful Global Compliance Program
Christine Mikail, Esq., Executive Vice President, General Counsel and Chief Compliance Officer, Dendreon; Former Senior Vice President, Corporate Development, Savient Pharmaceuticals, Inc.; Former Vice President, General Counsel & Secretary, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, New York, NY
Bert Weinstein, Esq., Vice President, Corporate Compliance, Purdue Pharmaceuticals; Former Vice President and Assistant General Counsel, Merck, Stamford, CT
Caroline West, Esq., Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc.; Former Vice President, Global Legal Compliance, Aventis, Philadelphia, PA
John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Co-Moderator)
Kelly N. “Nikki” Reeves, MPA, JD, Partner, King & Spalding LLP, Washington, DC (Co-Moderator)
3:00 pm Break
3:30 pm Compliance Data Metrics and AnalyticsThis session will focus on how data can be leveraged to provide business insights and trends to enable life sciences companies to monitor sales and marketing activities and strategize on future HCP/HCOfacinginvestments.
Bharathram Lakshmivarahan, Director, Pharmaceutical and Life Sciences Advisory, PwC, Philadelphia, PA
Jonathon Kellerman, Principal, Pharmaceutical and Life Sciences Advisory Services, PwC, Florham Park, NJ (Moderator)
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10:15 am Break
10:45 am Transactions Reviews for Non-CIA Organizations• ReviewsofHCPPaymentstoAssessCompleteness,AccuracyandControls• RequirementsofanIndependentReviewOrganizationwhen
TestingHCPPaymentsduringanAnnualTransactionsReview• TheDefinitionof“ControlDocuments”andtheirRelevance
totheSunshineActandTransactionsReviewTesting• KeyStepsinConductingyourownTransactionsReviewTeststo
AssessforGapsinCompliancetoInternalPoliciesandProcedures
Gus Papandrikos, MBA, Director of Compliance, Daiichi Sankyo; Former Director, Transparency Operations, sanofi-aventis, New York, NY
Jack T. Tanselle, Managing Director, Navigant Consulting, Inc., Indianapolis, IN
11:30 am Protecting Reputation and Relationships with Physicians and Teaching Hospitals• NotificationofReportedPhysicians• PostingInformationonCompanyWebsiteinAdvanceofCMS• PreparingPhysiciansre:Whattheywillsee• SupplyingMaterialsforPhysiciansre:WhyWorkwithIndustry• SupplyingMaterialsforPatientsontheAdvantagesofWorking
withIndustry• MediabeforeLaunchofPublicWebsite• MediaafterLaunchofPublicWebsite
Julia Galperin, Esq., Director, Commercial Compliance Operations, Genentech, South San Francisco, CA
Andrew Rosenberg, Esq., Co-Founder, Thorn Run Partners; Former Staff, Senate Health, Education, Labor and Pensions Committee, US Senate, Washington, DC
Sylvia J. Trujillo, MPP, JD, Legislative Counsel, Senior Attorney, Legislative Counsel Division, American Medical Association; Former Litigation Attorney, Office of the General, Centers for Medicare and Medicaid Services, Washington, DC
Thomas Sullivan, President, Rockpointe Corporation; Editor, policy and medicine, Columbia, MD (Moderator)
12:15 pm Networking Luncheon
1:15 pm Enforcement Panel• FederalSunshineenforcement• Stateenforcementactivityrelatedtodisclosure• Sunshine’simpactongovernmentinvestigationsandothercollateral
consequences
Margaret (Peg) Hutchinson, Esq., Assistant US Attorney, Civil Division, United States Attorney’s Office, Eastern District of Pennsylvania, Philadelphia, PA
Roann Nichols, Esq., Assistant US Attorney, United States Attorney’s Office, District of Maryland, Baltimore, MD
Robert Patten, Esq., Assistant Attorney General, Medicaid Fraud Division, The Commonwealth of Massachusetts; Co-chair, Global Case Committee, National Association of Medicaid Fraud Control Units, Holliston, MA
Jonathan Bach, Partner, Cooley, LLP, New York, NY (Moderator)
THURSDAy,FEBRUARy6,20147:00 am Registration Commences
DiSCloSure Summit DaY ii morninG plenarY SeSSion — the SunShine aCt8:00 am Welcome and Overview
Trudy J. Seeley, Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ (Co-chair)
8:15 am Interaction and Coordination between State and Federal Reporting Requirements: Strategies to Limit Risk• 2014willMarktheFirstYearwhenCompanieswillbeRequired
toJugglebothFederalandStateTransparencyReporting Simultaneously.
• ThisSessionwillIdentifyNewIssuesandPracticalConsiderationsArisingfromtheInterplaybetweentheFederalPhysicianPaymentSunshineActandStateTransparencyRequirements.
• WewillalsoReviewState-SpecificTransparencyRequirementsandEnforcementActivity,andDiscussPotentialStrategiesforManagingState-SpecificComplianceRisks.
• StateswithReportingRequirements:Massachusetts,Vermont, WashingtonDC,WestVirginia,Minnesota(for2014data)
• Stateswithbans/restrictionsimpactedby Sunshinereporting:California(limit),Louisiana (limit),Minnesota(limit),Vermont(ban)
Diane E. Bieri, Esq., Partner, Arnold & Porter, LLP; Former Executive Vice President and General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DCTrudy J. Seeley, Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ
9:00 am Coordination of Compliance amongst Multiple Affiliates Whetherduetopendingorin-progressmergersandacquisitionsorthe existence of independent corporate infrastructures, many com-panies operate as separate applicable manufacturers within the same corporate umbrella. This session will review compliance and business considerations such as:• Approaches to governance across applicable manufacturers • Whentoalign:Howtodeterminehowmuchcoordinationis
the right amount• Approach to shared business processes, systems and data • Challenges with customer communications • Considerationsonwhentofilejointlyvs.independently
Cheryl Gutowski, Associate Director, Integrity and Compliance, Novartis Vaccines and Diagnostics, Boston, MA
Jon Wilkenfeld, MBA, President, Potomac River Partners, Vienna, VA
9:45 am Challenges and Best Practices in Reporting Clinical Spend
Annadoir (Anna) Staveley, Compliance Manager, Ethics, Quality and Compliance, Otsuka America Pharmaceutical Inc., Rockville, MD Seth Whitelaw, JD, LLM, SJD, Director, Life Sciences Regulatory Compliance Practice, Deloitte & Touche LLP; Former R&D Compliance Officer, GlaxoSmithKline; Former Legal Compliance Officer, SmithKline Beecham, Philadelphia, PA (Moderator)
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2:15 pm In-Flight Aggregate Spend Data Monitoring Examples• Asource-by-sourceexaminationofprevailingdataissuesthroughout
thedatamanagementlife-cycle:datacollection,dataremediation,data aggregation and reporting.
Rajiv Shah, Director, Pharmaceutical and Life Science Advisory Services, PwC, New York, NY
Sarah Volden, Manager, Pharmaceutical and Life Science Advisory Services, PwC, Los Angeles, CA
3:00 pm Break
3:30 pm Fair Market Value• FocusofSessionwillbeonNewTrendsinFairMarketValue• Counsel’sview• ImpactofSunshineActonFMVforClinicalActivitiesandGrants• ChallengesandLessonsLearned• EvolvingInternationalTransparencyInitiativesandGlobalFMV
approaches and lessons learned• ServiceFeeFMV;GPOsandDistributorsExposure;NewCMSrules
are coming.
Eve M. Brunts, Esq., Partner, Ropes and Gray, Boston, MA
Mark A. DeWyngaert, MBA, PhD, Managing Director, Huron Consulting Group, New York, NY (Moderator)
4:15 pm Sunshine for Medical Device Manufacturers• SpecialConcernsofMedicalDeviceManufacturers• IncludingDemos/Loaners,Upgrades,PhysicianOwnership
Kevin Dill, Esq., Chief Compliance Officer, Olympus Corporation of the Americas, Philadelphia, PA
Nate Hwang, Esq., Chief Compliance Officer, Zimmer, Inc., Fort Wayne, IN
Christopher L. White, Esq., Senior Executive Vice President, General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC
Seth H. Lundy, Esq., Partner, King & Spalding, Washington, DC (Moderator)
5:00 pm Sunshine Data: Will it Help Qui Tam Whistleblowers and their Attorneys?• Sunshinedatawillmakeavailabletothepublicinformationthat
may be used by private citizens in civil lawsuits against providers and manufacturersundertheFalseClaimsActquitamwhistleblowerlaw.This law allows those with knowledge of fraud on the government to sueonthegovernment’sbehalfandshareintheproceeds.Billionsofdollars have been recovered from pharma and device manufacturers under this law.
• Thequitamlawprohibitstheuseofpubliclydisclosedinformation,subjecttocertainexceptions.WillthisoperateasasignificantbrakeontheuseofSunshinedatabyquitamwhistleblowersandtheircounsel?OrwillthecombinationofSunshinedataandthe2009amendmentstothe‘publicdisclosure’barprovideacompoundingeffect that will expose the drug and device industry to more lawsuits?
• Therealworldimplicationsandpotentialforthisnewlyavailableinformationtohelppotentialquitamplaintiffsminefordataorsupplementinformationtheyhavefromnon-publicsourceswillbediscussed by experienced practitioners.
Neil V. Getnick, Esq., Managing Partner, Getnick & Getnick LLP, New York, NY
Lesley Ann Skillen, Esq., Partner, Getnick & Getnick LLP, New York, NY
5:45 pm Adjournment
FRIDAy,FEBRUARy7,20147:00 am Registration Commences
DiSCloSure Summit DaY iii CloSinG plenarY SeSSion — CreatinG a GloBal tranSparenCY ComplianCe proGram FORTHEFUTURE8:00 am Welcome and Introductions
Ashish Kalgaonkar, MBA, Senior Director, Global HCP Transparency Reporting, Eli Lilly and Company, Indianapolis, IN (Co-chair)
8:15 am Global Challenge: Conducting Background Checks on the HCPs/HCOs• TransparencyReportingisRequiringCompaniestoConduct
BackgroundChecksontheHCPs/HCOs(ThirdParties)TheyareDoingBusinessWith
• ThirdPartieshaveDifferentRiskProfilesandDependingontheRiskProfileRequireDifferentLevelsofReview
• DuringthisSessiontheSpeakerswillReviewaMethodologyto ConductHCOReviewsinParticular
Ronny Arijs, Vice President, Global Sustainability and Chief Compliance Officer, Grunenthal; Member, EFPIA Compliance Workgroup; Former Senior Compliance Manager, GE Healthcare, Brussels, Belgium
Andy Bender, MS, MBA, President, Polaris, New York, NY
8:45 am Case Study in Implementing a Global Transparency Solution
David J. Eiben, Director, IS Business Partnering, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
William E. Buzzeo, MS, Vice President and General Manager, Global Compliance Solutions, Cegedim Relationship Management, Richmond, VA (Moderator)
9:15 am The Status of Implementation of EFPIA’s Code by Member Associations and, to the Extent Countries have done so, where are there Consistencies/ Inconsistencies among the Codes
D. Jeffrey Campbell, Esq., Managing Principal, Porzio, Bromberg & Newman; President, CEO, Porzio Life Sciences, LLC and Porzio Governmental Affairs, LLC, Morristown, NJ
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REGARDING WEBCAST REGISTRATIONS1.Individualsorgroupsmayregisterforwebcastaccess.Organizationsmayregisterforgroupaccesswithoutpresentingspecificregistrantnames.Insuchinstancestheregister-ing organization will be presented a series of user names and passwords to distribute to participants.
2.Eachregistrantwillreceiveausernameandpasswordforaccess.Registrantswillbeabletochange their user names and passwords and manage their accounts.
3.Webcastregistrantswillenjoysix(6)monthsaccessfromdateofissuanceofusernameand password.
4.Onlyoneuser(perusernameandpassword)mayvieworaccessarchivedconference.It is not permissible to share user name and password with third parties. Should webcast registrantschoosetoaccesspostconferencecontentviaFlashDrive,thisindividualuselimitation applies.
5. User name and password use will be monitored to assure compliance.
6.Eachwebcastregistrationissubjecttoa“bandwidth”orcapacityusecapof5gbperuserpermonth.Whenthiscapacityusecapishit,theregistrationlapses.Saidregistrationwillbeagain made available at the start of the next month so long as the registration period has notlapsedandissubjecttothesamecapacitycap.
7.Forwebcastregistrantstherewillbenorefundsforcancellations.Pleasecallthe ConferenceOfficeat800-503-0112or206-452-5237forfurtherinformation.
REGARDING ONSITE REGISTRATION, CANCELLATIONS AND SUBSTITUTIONS1.Foronsitegroupregistrations,fullregistrationandcreditcardinformationisrequiredforeach registrant. List all members of groups registering concurrently on fax or scanned cover sheet.
2.Foronsiteregistrantstherewillbenorefundsfor“no-shows”orforcancellations.Youmaysendasubstituteorswitchtothewebcastoption.PleasecalltheConferenceOfficeat800-503-0112or206-452-5237forfurtherinformation.
METHOD OF PAyMENT FOR TUITIONMakepaymenttoHealthCareConferenceAdministratorsLLCbycheck,MasterCard,Visaor American Express. Credit card charges will be listed on your statement as payment to HealthCare(HC)ConfLLC.ChecksormoneyordersshouldbemadepayabletoHealthCareConference Administrators LLC. A $30 fee will be charged on any returned checks.
REGISTRATION OPTIONSRegistrationmaybemadeonlineorviamail,faxorscan.Youmayregisterthrougheitherofthefollowing:•Onlineatwww.DisclosureSummit.com.•Fax/Mail/Emailusingthisprintedregistrationform.MailthecompletedformwithpaymenttotheConferenceregistrarat2252939thAve.SE,Bothell,WA98021,orfaxthecompletedformto206-319-5303,orscanandemailthecompletedformtoregistration@hcconferences.com.ChecksormoneyordersshouldbemadepayabletoHealthCareConferenceAdministratorsLLC.Thefollowingcreditcardsareaccepted:AmericanExpress,VisaorMasterCard.CreditcardchargeswillbelistedonyourstatementaspaymenttoHealthCare(HC)ConfLLC.
Forregistrantsawaitingcompanycheckormoneyorder,acreditcardnumbermustbegiventoholdregistration.IfpaymentisnotreceivedbysevendayspriortotheSummit,credit card payment will be processed.
TAX DEDUCTIBILITyExpenses of training including tuition, travel, lodging and meals, incurred to maintain or improveskillsinyourprofessionmaybetaxdeductible.Consultyourtaxadvisor.FederalTaxID:91-1892021.
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The Summit will pay a reward for information regarding unauthorized sharing of Summit content.Therewardwillbeonequarter(25%)ofanyrecoveryresultingfromacopyrightinfringement(lesslegalfeesandotherexpensesrelatedtotherecovery)uptoamaximumreward payment of $25,000. The payment will be made to the individual or individuals who intheopinionofourlegalcounselfirstprovidedthefactualinformation,whichwasneces-saryfortherecovery.IfyouhaveknowledgeregardingtheunauthorizedSummitcontentsharing,contacttheSummitregistrationoffice.
REGISTRATION BINDING AGREEMENTRegistration(whetheronlineorbythisform)constitutesacontractandallofthesetermsandconditionsarebindingontheparties.Inparticular,thesetermsandconditionsshallapplyinthecaseofanycredit/debitcarddispute.
GENERAL TERMS AND CONDITIONSProgramsubjecttocancellationorchange.Iftheprogramiscancelledtheonlyliabilityofthe Summit will be to refund the registration fee paid. The Summit shall have no liability regardingtravelorothercosts.Registrationformsubmittedviafax,mail,emailoronlineconstitutes binding agreement between the parties.
FOR FURTHER INFORMATIONCall800-503-0112(ContinentalUS,AlaskaandHawaiionly)or206-452-5237,sende-mailtoregistration@hcconferences.com,orvisitourwebsiteatwww.DisclosureSummit.com.
THEFOllOWINGREGISTRATIONTERMSANDCONDITIONSAPPly
9:45 am Best Practices in Implementing a Coordinated Global Transparency Program
Evelyne Lemaire, Director, Global Pharmaceutical and Life Sciences, PwC Zurich, Switzerland
10:15 am Break
10:30 am Practical Approaches to Global Transparency Compliance• FrenchSunshine:WhathaveweLearned?• GlobalversusLocalConsiderations• NavigatingPracticalChallenges• InconsistentRules• TightTimelines• DataPrivacy
DISCLOSURE SUMMIT CONTINUING EDUCATION UNITS (CEUs)COMPLIANCE CERTIFICATION BOARD (CCB) CREDIT The event has been approved for 23.4 CCB CEUs.
NASBA CPE CREDIT HealthCareConferenceAdministrators,LLCisregisteredwiththeNationalAssocia-tionofStateBoardsofAccountancy(NASBA)asasponsorofcontinuingprofessionaleducationontheNationalRegistryofCPESponsors.StateboardsofaccountancyhavefinalauthorityontheacceptanceofindividualcoursesforCPEcredit.ComplaintsregardingregisteredsponsorsmaybesubmittedtotheNationalRegistryofCPESpon-sors through its website: www.learningmarket.org. A recommended maximum of 24.0 creditsbasedona50-minutehourwillbegrantedfortheentirelearningactivity.Thisprogram addresses topics that are of a current concern in the compliance environment. Thisisanupdate,group-liveactivity.Formoreinformationregardingadministrativepoliciessuchascomplaintsorrefunds,call425-233-5075oremailpjgrant@ehcca.com.
PENDING CONTINUING EDUCATION CREDITS
Attorneys: The The Summit is currently pending approval to offer California, Pennsylvania and Texas MCLE Credit.
CERTIFICATE OF ATTENDANCE TO SUBMIT FOR CONTINUING EDUCATION UNITS (CEUs) OnsiteattendeescanrequestaCertificateofAttendancewhichtheycanfilewithappropriate entities for credits not offered by the Summit, and webcast attendees can requestaWebcastCertificateofAttendanceonwhichtheycancertifythenumberofhourstheywatchedandcanfilewithappropriateentitiesforcredit.
• CustomerConcerns
• Leveragingthebenefitsoftransparency
Sujata Dayal, JD, LLM, Vice President Health Care Compliance and Privacy, Pharmaceuticals, Johnson & Johnson; Former Global Chief Compliance Officer and Corporate Vice President, Biomet, Inc.; Former Ethics and Compliance Officer - Pharmaceutical Products, Abbott Laboratories, Chicago, IL
Ashish Kalgaonkar, MBA, Senior Director, Global HCP Transparency Reporting, Eli Lilly and Company, Indianapolis, IN
Michael D. Petty, Esq., Partner, King & Spalding LLP; Former Vice President of Development and Regulatory Law, Amgen Inc., Washington, DC
Carolyn Bruguera, Esq., Vice President, Consulting Services and General Counsel, R-Squared; Former Vice President and General Counsel, Hansen Medical, Princeton, NJ (Moderator)
12:00 pm Adjournment
FRIDAy,FEBRUARy7,2014 Continued from Previous Page
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CONFERENCE –STANDARD RATE: ❏ ThroughFriday,December13,2013* $1,795 ❏ ThroughFriday,January10,2014** $1,995 ❏ AfterFriday,January10,2014 $2,195
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GROUP REGISTRATION DISCOUNT: Three or more registrations submitted from the same organization at the same time receive thefollowingdiscountedratesforconferenceregistrationonly.Toqualify,allregistrationsmustbesubmittedsimultaneously.Ratesareperperson.❏ ThroughFriday,December13,2013* $1,595 ❏ ThroughFriday,January10,2014** $1,795 ❏ AfterFriday,January10,2014 $1,995
CONFERENCE ELECTRONIC MEDIA:OnsiteAttendees—FollowingtheSummit,thevideoandpresentationsaremadeavail-able in the following formats. To take advantage of the discounted prices below, you must reservemediaWITHyourSummitregistration:❏ FlashDrive($129+$15shipping)$144❏ 6months’accessonWeb$129
WEBCAST CONFERENCE ATTENDANCEWebcastconferenceregistrationincludestheliveInternetfeedfromtheSummit,plussixmonthsofcontinuedarchivedInternetaccess,available24/7.
INDIVIDUAL REGISTRATION: ❏ ThroughFriday,December13,2013* $795 ❏ ThroughFriday,January 10, 2014** $1,095 ❏ AfterFriday,January 10, 2014 $1,395
SPECIAL PHARMACEUTICAL COMPLIANCE FORUM (PCF) RATE ***: ❏ ThroughFriday,December13,2013* $595 ❏ ThroughFriday,January 10, 2014** $795 ❏ AfterFriday,January 10, 2014 $895
GROUP REGISTRATION:Group registration offers the substantial volume discounts set forth below. Group registration permits the organizational knowledge coordinator either to share con-ference access with colleagues or to assign and track employee conference participation. Ratesareperperson.Conference Access: ❏ 5ormore$595each ❏ 20ormore$395each ❏ 10ormore$495each ❏40ormore$295each
SeeINTELLECTUALPROPERTYPOLICY,page6.
CONFERENCE ELECTRONIC MEDIA:Webcastattendees—FollowingtheSummit,thevideoandpresentationsaremadeavail-able on a flash drive. To take advantage of the discounted price below, you must reserve mediaWITHyourSummitregistration: ❏ FlashDrive($129+$15shipping)$144
(Allwebcastattendeesautomaticallyreceive6monthsaccessonweb.)
REGISTRATION BINDING AGREEMENTRegistration(whetheronlineorbythisform)constitutesacontractandallofthesetermsandconditionsarebindingontheparties.Inparticular,thesetermsandconditionsshallapplyinthecaseofanycredit/debitcarddispute.Forwebcastandonsiteregistrantstherewillbenorefundsfor“no-shows”orcancellations.
ACCOUNT#
EXPIRATIONDATE SECURITYCODE
NAMEOFCARDHOLDER
SIGNATUREOFCARDHOLDER
PAyMENT Discount Code:The use of a registration discount code cannotbethebasisofrequestinga partial refund of fees already paid.
TOTAL FOR ALL OPTIONS, ONSITE OR WEBCAST:PleaseenclosepaymentwithyourregistrationandreturnittotheRegistraratDisclosureSummit,2252939thAveSE,Bothell,WA98021,orfaxyourcreditcardpaymentto 206-319-5303.
Youmayalsoregisteronlineatwww.DisclosureSummit.com.
❏ Check/moneyorderenclosed(payabletoHealthCareConferenceAdministratorsLLC)
❏ Payment by credit card: ❏ American Express ❏ Visa❏ MastercardIfacreditcardnumberisbeinggiventoholdregistrationonlyuntilsuchtimeasa checkisreceiveditmustbesonoted.Ifpaymentisnotreceivedbysevendayspriorto the Summit, the credit card payment will be processed. Credit card charges will be listed onyourstatementaspaymenttoHealthCare(HC)ConfLLC.
*ThispricereflectsadiscountforregistrationandpaymentreceivedthroughFriday,December13,2013.
**ThispricereflectsadiscountforregistrationandpaymentreceivedthroughFriday, January 10, 2014.
***ToqualifyforthePCFmemberrateanindividualmustbeaemployeeofamembercom-panyofthePharmaceuticalComplianceForum(PCF),www.PharmaComplianceForum.org.
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