Corporate Compliance & Transparency in the Pharmaceutical Industry

Silver Sponsor: Promotional Sponsor:Lunch Sponsor:

www.fleming.events

OUR SPECIAL FEATURES

•On-StageInterviewwith EFPIA

•HCPinsight •Specialdebate •Focuseddiscussions

KEY BENEFITS OF ATTENDING

•GetanupdateontheimplementationofDisclosureCodeandthefirstoutcomesandevaluateyourimplementationprocess

•Unravelcompliancechallengesrelatingtodata privacy

•DefineFairMarketValueanddevelopaconsistent,simpleandtransparentmethodforyourcompany

•LearnhowtooptimiseinteractionswithHCPsandHCOsthroughafullycompliantandtransparentstrategytoobtainconsent

•Findoutcomplianceimplicationsandconcernsfor mergingcorporatecultures

•Uncoverhowtoestablishanadequateinvestigation manualandprocedures

4th AnnuAl CorporAte

CompliAnCe & trAnspArenCy

in the Pharmaceutical industry

24 - 25 February 2016 mövenpick hotel Zürich- regensdorf, Zürich

OUR SPEAKER PANEL

RICHaRDBeRGStROM eFpiA | DirectorGeneral

NINA STOECKEL | merck KGaA Director,HeadofGroupComplianceProgramsLe-CP

RICHaRDWaLteRSGlaxosmithKline Headofethics&Compliance,Pharmaeurope

See full speaker panel on the next page

GRPTRUE DILIGENCE

Media Partners:

OUR SPEAKER PANEL

NINA STOECKEL | merck KGaA Director,HeadofGroupComplianceProgramsLe-CP

KARL BOONEN | Johnson & Johnson SeniorDirectorBusinessPracticesandCompliance eMea&Canada

MaRCeLaKIRBeRGeR|sandoz GlobalComplianceOfficer

CHRIStOPHeLeSGUeR|mylan VicePresident,ChiefComplianceOfficereurope

RICHaRDWaLteRS|GlaxosmithKline Headofethics&Compliance,Pharmaeurope

DETLEF GEIGES | AstraZeneca|HeadofCorporateGovernance/areaComplianceLeadDe,at,CH

NeLINeDKOVa|Boehringer-ingelheim HeadofCompliance&ethicsCentraland easterneurope

MILeNaYaKIMOVa|Actavis Directorethics& Compliance–Centraleastern & Southeasterneurope

MeLteMOzKeRGUNDUz| novo nordisk Legalaffairs&ComplianceDirectorBusiness areaNeareast(BaNe)

MaRItPLeSS|intermune europeanLegalCounsel,ethicalComplianceDirector

LeONaRDOSILVa|Acino pharma AG HeadofCompliance

MaRIateReSaRICO|Biogen eURegionalComplianceOfficerandJVBiosimilarsComplianceOfficer

DOMINIqUeOLIVeRaHNSeHL Bayer HealthCare |ComplianceCounsel

MICHIeLLODeWIJKS|roche|ComplianceOfficer

RICHaRDBeRGStROM|european Federation of pharmaceutical industries and Associations - eFpiA|DirectorGeneral

aDRIaNVaNDeNHOVeN|european Generic and Biosimilar medicines Association - eGA DirectorGeneral

CaRINSMaND|european Hematology Association - eHA|ManagingDirector

MILaDaBRaBCOVa|eli lilly | ComplianceDirector

NeeRaJSINGHaL|medispend VicePresident,ProductManagementandMarketing

KatIeJaCYNa|medispend ProductManager

tIMROBINSON,eSq.|medispend ChiefKnowledgeOfficer/GeneralCounsel

NICOLAS GIANNAKOPOULOS | Global risk profile FoundingPartner

aNtHONYPaPON| Accenture|ManagingDirector

PaULMeLLING| Baker & mcKenzie |Partner

KpmG

OURaDVISORYCOMMIttee

eStHeRVaNWeeRt F. hoffmann - la roche Pharma Healthcare Compliance Leader Europe

GIAN LUCA TRINEI Pfizer Chief Compliance Officer

MaRItPLeSS intermune European Legal Counsel

MILaDaBRaBCOVa eli lilly, Compliance Director

MILeNaYaKIMOVa actavis |Director Ethics & Compliance – Central Eastern & South Eastern Europe

HaLGLaSSeR Former Senior Director Chief Ethics & Compliance Officer sanofi Pasteur msd

eVeNtINtRODUCtION

thepastdecadehavewitnessedawaveofglobaltransparencyinthepharmaceutical industry,and2015hasmarkedthestartofanewera ineurope.Companieshaveexerted todesignand implementprocesses thatmeet spend transparencyanddisclosurerequirements.From2016,pharmahavetomakepublicitspaymentstodoctorsandhealthcareorganisationsineurope,whichisnotonlyahugetechnicalchallenge,butalsoamajorculturalshift.

thisconferencewillserveasaplatformtodiscusscomplianceandtransparencyareasofkeyconcern.Donothesitate,takethisgreatnetworkingopportunityandjoinusinzürich!

WHOWILLYOUMeet?

CxOs,SVPs,Vps,Globalheads,Heads,Directors,Officers,Counsels,ManagersofPharma/Biotechcompanies responsible forCompliance,ethics/Businessethics,Legal,Regulatoryaffairs,RiskMonitoringetc.RepresentativesofLawfirms,Governmentalbodies,auditcompanies,etc.

Supporting Partner:

Booking line: tel:+421257272155,fax:421255644490

email:[email protected],www.fleming.events

Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor:

www.flemingeurope.com

3rd AnnualCorPorAte ComPliAnCe

& trAnSPArenCy in the Pharmaceutical industry25th – 26th February 2015, Zürich, Switzerland

Swissotel ZurichOur Speaker panel:

Julie BOnhOmme, eFpia legal Affairs & Compliance Deputy Director

klauS GeldSetzer Santen Chief Compliance officer europe

Ole Wendler pederSen nOvO nOrdiSk General Counsel region europe Director legal, Compliance & Business Development

nick tyler takeda pharmaceuticalS internatiOnal Director Compliance & Data Privacy

milada BraBcOva eli lilly Compliance Director

milena yakimOva actaviS Director ethics & Compliance – Central eastern & South eastern europe

nader khedr SandOz Head regional Compliance - meA

SanGeetha karpOre kumar dr. reddy‘S laBOratOrieS Associate Director, Compliance Head emerging markets

tOmaSz kruk mallinckrOdt pharmaceuticalS Director international Compliance

eSther van Weert rOche and rOche diaGnOSticS Pharma Healthcare Compliance leader - europe

JarOSlav vaSil Bayer healthcare Senior Business Advisor

marit pleSS intermune internatiOnal european legal Counsel

dan zavOdnick Bayer healthcare llc Corporate Counsel

JakuB dvOřáček aiFp (czech aSSOciatiOn OF innOvative pharmaceutical induStry) executive Director

rOlF Stahel eurOpean SOciety FOr medical OncOlOGy (eSmO) President

timOthy rOBinSOn mmiS inc./ mediSpend Chief Knowledge officer & General Counsel

martiJn de kieWit kpmG Head of ethics and Compliance management

paul mellinG Baker & mckenzie Partner

Geert van GanSeWinkel pOlariS SOlutiOnS managing Director europe

Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor:

www.flemingeurope.com

3rd AnnualCorPorAte ComPliAnCe

& trAnSPArenCy in the Pharmaceutical industry25th – 26th February 2015, Zürich, Switzerland

Swissotel ZurichOur Speaker panel:

Julie BOnhOmme, eFpia legal Affairs & Compliance Deputy Director

klauS GeldSetzer Santen Chief Compliance officer europe

Ole Wendler pederSen nOvO nOrdiSk General Counsel region europe Director legal, Compliance & Business Development

nick tyler takeda pharmaceuticalS internatiOnal Director Compliance & Data Privacy

milada BraBcOva eli lilly Compliance Director

milena yakimOva actaviS Director ethics & Compliance – Central eastern & South eastern europe

nader khedr SandOz Head regional Compliance - meA

SanGeetha karpOre kumar dr. reddy‘S laBOratOrieS Associate Director, Compliance Head emerging markets

tOmaSz kruk mallinckrOdt pharmaceuticalS Director international Compliance

eSther van Weert rOche and rOche diaGnOSticS Pharma Healthcare Compliance leader - europe

JarOSlav vaSil Bayer healthcare Senior Business Advisor

marit pleSS intermune internatiOnal european legal Counsel

dan zavOdnick Bayer healthcare llc Corporate Counsel

JakuB dvOřáček aiFp (czech aSSOciatiOn OF innOvative pharmaceutical induStry) executive Director

rOlF Stahel eurOpean SOciety FOr medical OncOlOGy (eSmO) President

timOthy rOBinSOn mmiS inc./ mediSpend Chief Knowledge officer & General Counsel

martiJn de kieWit kpmG Head of ethics and Compliance management

paul mellinG Baker & mckenzie Partner

Geert van GanSeWinkel pOlariS SOlutiOnS managing Director europe

PaStCONFeReNCeSINNUMBeRS

60% WeSteRNeUROPe

18% CENTRALandEASTERN EUROPE

16% SOUtHeRNeUROPe

6% USA

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PRAGUE 2013

BERLIN 2014

züRICH2015

VEry COnStruCtiVE! VEry wELL OrganiSED!GroupCorporateGovernanceandComplianceOfficerDirector,Helsinn

VEry intErESting anD uSEFuL tO HEar OtHEr COMPaniES ExPEriEnCE anD LEarn baSED On tHiSComplianceManager,GlaxoSmithKline

ExCELLEnt OPPOrtunity tO gain knOwLEDgE anD SHarE ExPEriEnCEDeputyHeadofLegalaffairsDivision,Hemofarm

ON-StaGeINteRVIeW tHetaLK ExPERT PANELS

SPECIAL DEBATE NetWORKING INteRaCtIVeaPP

CONFERENCE FEATURES



CONFeReNCeDaY1|24thFeBRUaRY2016

8:30 ReGIStRatIONCOFFee

9:00 WeLCOMINGNOteFROMFleminG.

9:05 OPeNINGReMaRKSFROMtHeCHaIR

9:10 ON-StaGeINteRVIeW:eFPIa–UPDateONIMPLeMeNtatIONOFDISCLOSUReCODe

• Do‘sanddon‘tswhenimplementingeFPIa‘scodes

• What‘sgoingtohappennextoncethedataisdisclosed?

• Whatarethechallengesanticipatedregardingexternalcommunication?

• Whatarethechallengesinspecificcountriesrelatedtodisclosure?

richard BerGstrom | european Federation of pharmaceutical industries and Associations - eFpiADirector general

9:40 tRaNSPaReNCYOBLIGatIONS–exaMPLeSOF IMPLeMeNtatIONaNDFIRStOUtCOMeS

transparencyobligationsareontherise. the EFPia Code on Disclosures of transfers of Value From Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations requiredreportingstartingin2016for2015 spend.

• evaluationoftheimplementation

• awalkthroughofthepracticalimplementationoftransparencyprocesses

• Industryfirstobservationsafterdisclosureofdata

• Countrybycountrydifferencesincentralreporting

• Progressonmanagingcommunicationwithhealthcareprofessionals

neli nedkova | Boehringer-ingelheimHead of Compliance & Ethics Central and Eastern Europe

dominique oliver ahnsehl | Bayer HealthCare Compliance Counsel

10:30 MORNINGCOFFee&NetWORKING

11:00 LOCaLPeRSPeCtIVe:DISCLOSUReaNDTRANSPARENCY LESSONS LEARNED

ComplyingwiththeeFPIaCodeonDisclosureoftransfersofValuetoHealthcareProfessionalsandHealthcareOrganisationswillbeaverycomplexbusiness.thisisnotleastbecauseeachofthe33countriesinvolvedhasitsownslightlydifferentapproachtocomplyingwiththeCode.

• Lessonslearnedfromonelocationcanbeappliedasmoreassociationsandcountriesimplementtransparencyrequirements

michiel lodewijks | roche | Compliance Officer

meltem oZker GunduZ | novo nordisk | Legal affairs & Compliance Director business area near East (banE)

milena yakimova | Actavis | Director Ethics & Compliance – Central Eastern & South Eastern Europe

12:00MeDISPeND

topicstobeannouncedsoon

12:30PaNeLDISCUSSION

Featuringmorningspeakers

12:50 LUNCH HOSteDBY

14:00 tHetaLK–DeteRMININGFaIRMaRKetVaLUe

afteranintroductiontothetopicgivenbyoneofourspeakers,participantswillhavetheopportunitytosharetheirknowledgeandexperience.Participantswilljoina tableandbecomeanactivepartofthediscussionathand.togetthemostoutofthisinteractivesessionandformatpleasecomepreparedtoshareexamplesfromyourwork,sharesomeideaswithyourpeers,beapartof groupdiscussions,and,mostimportantly,participatein activeideasharing.

FaIRMaRKetVaLUeCONSIDeRatIONS:WHatDOeSFMVMatteR?

• ScrutinyrelatedtopaymentstoHCPs

• Legitimatepaymentsforservices

• WhydoesFMVmatter?

• CurrentthinkingonFMVmethodology

• HowtomonitorFMVcompliancetomitigateriskofanti-corruptionviolations?

• FMVDiscussions

milada BraBcova | eli lilly Compliance Director

14:30 MaNaGINGtHIRD-PaRtYRISKS–WHYItMatteRSMORetHaNeVeRBeFORe

effectivecompliancealwayscomeswithefficientriskmanagement.thissessionwillexplorehowtotacklerisksposedbyclients,intermediaries,suppliers,stakeholdersandotherthirdpartiesandwhyitisnotenoughtosimplygothroughtheregulator’schecklist.

• Howtoidentifythird-partyrisksinacomplexbusinessenvironment

• Waystomanagethird-partyrisks

• trueDiligenceofpotentialpartnersandexistingones

nicolas GiannakoPoulos | Global risk profile Founding Partner

15:00 COLLeCtINGDeCLaRatIONSOFCONSeNtINaCROSS-BORDeReNVIRONMeNt:POSSIBLeaPPROaCHeSaNDCHaLLeNGeSneli nedkova | Boehringer-ingelheim Head of Compliance & Ethics Central and Eastern Europe

15:30 DataPRIVaCYaNDCONSeNtMaNaGeMeNtanthony PaPon | Accenture | Managing Director

16:00 aFteRNOONtea&NetWORKING




16:20 KeYNOte:eGa–CODeOFCONDUCtFOReUROPeaNGeNeRICaNDBIOSIMILaRMeDICINeSINDUStRY

• WhatistheeGaCodeofConductonInteractionswithHCPs?

• WhatdoestheeGaCodeunderstandbytransparency?

• HowistheeGaCodegoingtobeimplemented?

• HowistheeGaCodegoingtobeimplementedincountrieswhereethicalcodesalreadyexist?

adrian van den hoven | european Generic and Biosimilar medicines Association - eGA Director general

16:50 CaSeStUDY:COMMUNICatIONaNDReLatIONSHIPSWItHHCPS

• OptimisinginteractionswithHCPsthroughafullycompliantandtransparencystrategy

• SupportingdocumentationforactivitiesandinteractionswithHCPsandHCOs

• ManagingconsentwithHCPs

richard walters | GlaxosmithKline Head of Ethics & Compliance, Pharma Europe

17:20SPeaK-UPCULtURe

christoPhe lesGuer | mylan Vice President, Chief Compliance Officer Europe

17:50 SPeCIaLDeBate:PUtYOURSeLFINMYSHOeS

Ourspeakersfrompharma industryandmedical communitywillgetoutofthecomfortzonebyswitchingsidesand,fromanopposedperspective,willpresentargumentstosupporttheirpositioninregardtotheirrelationshipandthebenefitsandthehurdlesofdisclosurerequirements.

carin smand | european Hematology Association - eHA | Managing Director

18:20 eVaLUatIONOFDaY1&CLOSINGReMaRKSFROMtHeCHaIR

Speakersanddelegatesarecordiallyinvitedtoattend

aNetworkingCocktailReception




11:00 MORNINGCOFFee&NetWORKING

11:20 BeStPRaCtICeS:COMPLIaNCePROGRaMStRUCtUReaNDeFFeCtIVeNeSS• Strengtheningtheroleofcompliancewithinthe

organisation• engagingwithleadershiptominimisetheimpactof

regulatorypressuresontheachievementofstrategicgoals

• Implementingstrategicchangestomanagecurrentandemergingrisks

• Fittinganti-corruptionandanti-briberywithinexistingcompliance,legalandotherobligationstoolsavailabletomanageinternalprocesses

• theroleofdatacollectioninidentifyingriskandexposures

marcela kirBerGer | sandoz global Compliance Officer

leonardo silva | Acino pharma AG Head of Compliance

maria teresa rico | Biogen | Eu regional Compliance Officer and JV biosimilars Compliance Officer

12:20 CaSeStUDY:COMPLIaNCeIMPLICatIONSaNDCONCeRNSFORMeRGINGCORPORateCULTURES•Challengesassociatedwithperformingduediligence

andcombiningcomplianceprocesses•Howtoensureduediligencepost-acquisitionsand

mergers•Howtoaligntheroleofinternalcomplianceteams

in bothorganisations

KpmG (to be confirmed)

12:50 LUNCHHOSteDBY

14:00 teaMStRUCtUReISCRItICaLtOSUCCeSS•Howtosetupacomplianceteamtodeliveronkey

objectivesofacompliancefunction•Whichcapabilitiesarekeyforsuccess•ComplianceCommunication:MakeCompliance

a topicforeveryoneandfosteraccountabilityacrossthecompany

nina stoeckel | merck KGaA Director, Head of group Compliance Programs LE-CP

14:30 tHIRDPaRtIeS–ORGaNISINGaNaPPROaCHFORCOMMUNICatION,tRaININGaNDMONItORING•Casestudiesoncollaboratingwiththirdparties•Whicharethemostcommonreasonsthatthird

partiesfailtomeetyourstandardsforanti-briberycompliance?

• Comparingapproachesforlarge,mediumandsmallcompanies

•Definingaprocessforqualifyingthirdparties• auditingandmonitoringprogramstoensure

accuracy•Managingthirdparties:globally,locallyorby

headquarters

Paul mellinG | Baker & mcKenzie Partner

karl Boonen | Johnson & Johnson Senior Director business Practices and Compliance EMEa & Canada

15:30 q&aDISCUSSION

15:45 aFteRNOONtea&NetWORKING

9:00 workshoP a MaNaGINGHeaLtHCaRePROFeSSIONaL(HCP)eNGaGeMeNtFROMNeeDSaSSeSSMeNttOPaYMeNtSmoderators: neeraj sinGhal | medispendVicePresident,ProductManagementandMarketing.

katie jacyna | medispend | ProductManager

WORKSHOPOBJeCtIVeS:• Keyaspectsandchallengesfacedbyglobal

companiesin engagingHCPsinamulti-countryenvironment

• IdentifykeyplayerswithinthecompanyinHCPengagementprocess

•ManaginginternationalHCPsandhandlingthecrossboardercomplexities

• Identifyingtheprocess,people,andcommunicationchallengeswithinglobalorganizations

•MediSpend’sunderstandingandapproachtosolvingthiscomplexproblem

9:00 workshoP B BUILDINGaNeFFeCtIVeaNtI-CORRUPtIONaNDaNtI-BRIBeRYPROGRaM

moderators:

tim roBinson | medispend esq.,ChiefKnowledgeOfficer/GeneralCounsel

WORKSHOPOBJeCtIVeS:

Interactionswiththird-parties,includingagents,distributors,consultantsandothers,poseasignificantrisktolifesciencecompanies.throughthisworkshop,participantswillsharebest-practicesforbuildinganeffectiveanti-corruptionandanti-briberyprogram.throughthisworkshopandinteractivediscussion,participantswillgainactionableinsightsandunderstandbest-practicestobenchmarkand improvetheirexistingcomplianceprogram.topicstobediscussedinclude:• Bestpracticesforselectingandsourcing3rdparties• Riskbasedthird-partyduediligenceprocedures•Documentingservicestobeperformedandrelated

terms•Conductingeffectivetrainingforemployeesand

3rd parties



16:00 CONDUCtINGINteRNaLINVeStIGatIONS• establishinganadequateinvestigationmanual

and procedures•Determininghowfaryoushouldgowithyour

internalinvestigation• Stepbystepinternalinvestigation

marit Pless | intermune European Legal Counsel, Ethical Compliance Director

16:30 COMPLIaNCeaNDRISKaSSeSSMeNt• Shiftingfrombeing‚reactive‘torisktobeing

proactiveaboutmanagingandmitigatingriskandexecutionbeforeitbecomesanissue

• analysingdataandsignstoidentityandprioritiserisks• anti-corruptionandanti-briberyrisks:Improving

collaborationbetweenteamstoknowwhenredflagsshouldberaised

• Isyouranti-briberypolicyadiscrete,documentedprocess,orpartofabroaderpolicyaddressingvariouscompliancerisks?

•Companyrepresentatives‘activities–whatarethekeyareastoaddresspriortosendingpersonnelintothefield?

detleF GeiGes | AstraZeneca | Head of Corporate governance/ area Compliance Lead DE, at, CH

17:00 WRaPUPSeSSION:

attendeeswillsharetheirfindingsandwillbegiventheopportunitytoaskextraquestionsto speakers.

17:30 eVaLUatIONOFtHeCONFeReNCe&CLOSINGReMaRKSFROMtHeCHaIR

17:35 FaReWeLLCOFFee


applicationeNSURetHatYOURtIMeattHeCONFERENCE IS eFFeCtIVeaSWeLLaSFUN,WItHOURNeWONLINeEASILY ACCESSIBLE NetWORKINGaPP.

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Forfurtherinformationpleasecontact:

dasa janosikova

ProductionManagerLifeSciences

PhoneNo.:+421257272104 email:[email protected]



OUR SPEAKERS

aDRIaNVaNDeNHOVeNeuropean Generic and Biosimilar medicines association – eGa, BelgiumDirector general

adrian van den Hoven, joined theeuropean Generic and Biosimilarmedicinesassociation(eGa)asaDirectorGeneralinSeptember2013.Hisprioritiesat theeGaare to stimulatecompetitioninoff-patentmedicinemarkets,tofostermarketaccess forgenericandbiosimilarmedicines, to support policy measuresfor sustainablepricing, topromotehighregulatorystandardswhileensuringthatthe associated costs can be integratedintomarket dynamics and to develop acoherenteUindustrialstrategytosupportthe long-term viability of the genericand biosimilar medicines industry. Priorto joining the eGa, adrian van denHoven was Deputy-Director Generalof BUSINeSSeUROPe where he wasresponsiblefortheInternationalRelationsdepartment,coveringtradenegotiationsand bilateral relations, and the Industrydepartment, covering industrial, energy,environmental and research policy. Hepreviously worked as an InternationalRelations researcher and an adjunctprofessor in Italy (eUI), France (Nice)andCanada (Windsor). He obtained hisdoctorate in Political Science from theUniversityofNice,Francein2000.

DOMINIqUeOLIVeRaHNSeHLBayer healthcare, GermanyCompliance Counsel

Dominique Oliver ahnsehl is currently acting as

Compliance Counsel for BayerheadquartersinGermany.Heisresponsiblefor different compliance projects andacting as legal and compliance supportfor the transparency solution of Bayer.additionally, he is the business partnerfor theeFPIa regionand the regionasiaPacific.

CaRINSMaNDeuropean hematology association - eha, the netherlandsManaging Director

SinceJanuary1,2008CarinSmandhasbeentheManagingDirectoroftheeuropeanHematologyassociation(eHa)whichhasitsexecutiveOfficeintheHague,theNetherlands.eHa,anonprofit

organizationfoundedin1992,promotesexcellence in clinical practice, researchandeducation in europeanhematology.Since shehasworked for eHahermainfocushasbeento furtherprofessionalizethe organization by working towardsthe development and implementationof the association’s strategy and policy,especially in the areas of continuousmedical education, the relationshipwith pharmaceutical industry, lobbyingactivities,andinternationalcollaboration.

after a 10 year career in accountancyandtaxsheworked for11years for theDutch Health Care Insurance Board aspolicy maker and Secretary of variousmedical specialty committees, advisingthe Minister of Health on the publichealth care insurance system. after thatsheworkedasanationalcoordinatorfororganandtissuedonationfortheDutchtransplantFoundation.

Carin Smand studied Health Sciences(policyandstrategy)attheUniversityofMaastricht and Business economics attheHogeschoolamsterdam(amsterdamUniversityofappliedSciences).

DETLEF GEIGESastraZeneca, Germany Head of Corporate governance/area Compliance Lead DE, at, CH

Detlef currently holdsa position of Compliance area LeadGe, at, CH and is responsible for thecompliance leadership in the respectiveareaandcontributiontoeCLtandseveralregional/global projects. Since 2011, hebecameHeadofCorporateGovernance,member of SMt at astrazeneca, wherehe gained extensive experience incompliance business partnering andassurance,includingcompliancesupportand advice,maintenanceof governance& assurance framework of monitoring,auditing,incidentmanagement,training,aswellasinfinancialcontrolsframeworkandrisk&crisismanagement.

Detlef started his professional career atClinserve Clinical trial Services in 1996andjoinedastrazenecaGermanyMedicalDepartment in 1998. Between 1998and 2011, Detlef went through variouspositions with increasing responsibilitiesinclinicalresearch&operations.

Detlef studied Biology at the Universityof Freiburg and completed his PhD incellular biology/signal transductionat German Cancer Research Center,Heidelberin1995.

RICHaRDBeRGStROMeuropean Federation of Pharmaceutical industries and associations - eFPia, BelgiumDirector general

RichardBergströmhasbeentheDirectorGeneral of the european Federationof Pharmaceutical Industries andassociations (eFPIa) since april 2011.Previously he served for nine years asthe Director-GeneralofLIF,theSwedishassociationofthePharmaceuticalIndustry,following positions in Switzerland inregulatory affairs at the pharmaceuticalcompanies Roche and Novartis. MrBergström was also appointed by theSwedishGovernmenttotheBoardoftheKarolinskaInstitute.Heisapharmacistbytraining,receivinghisMScPharmdegreefrom theUniversity of Uppsala, Swedenin1988.

RICHaRDWaLteRS

Glaxosmithkline, ukHead of Ethics & Compliance, Pharma Europe

DrRichardWalters isHeadof ethics & Compliance

for Pharma europe & Canada atGlaxoSmithKline, based in London. Inhis role Richard leads a team of over70 compliance professionals and isa member of GSK’s Global ethics &Compliance Leadership team. Richardjoined GSK in 2005, following thecompletion of his DPhil studies inPharmacology at Oxford University,where he has held roles of increasingresponsibility within R&D, Regulatoryaffairs, Scientific Communications,Medical affairs, Corporate Strategywithin theCeO’sofficeandCommercialOperations;duringthistimehehasbeenlocated in the UK, France, India andSpain. Richard is a current member ofeFPIa’sethics&ComplianceCommittee,a certified Leading Professional in ethicsandCompliance(LPeC)andhasanMBafromWarwickUniversityBusinessSchool.



KAROLINA CzeRNICKa-KUHLnovo nordisk, PolandHead of Legal and Compliance Europe East

Karolina Czernicka-Kuhl,is heading the Novo Nordisk Legal& Compliance function in europe east,covering 17 countries. Prior to joiningNovo Nordisk, Karolina worked for over12 years at Linklaters (a leading globallawfirm)inWarsawandLondonfocusingmainly on mergers and acquisitions, aswell as investment funds management.SheholdsamasterdegreeinlawfromtheUniversity of Warsaw, Poland and L.LMfrom University of Münster, Germany.Karolina is an attorney-at-law for PolandandasolicitorforenglandandWales.

LeONaRDOSILVa

acino Pharma aG, switzerlandHead of Compliance

LeonardoSilvaheadsacino’sCompliance department

globally, based out of the company’sglobal Hq in Basel, Switzerland. Priorto that, Leonardo worked for takedaPharmaceuticals in both Brazil and inSwitzerland’s International hub, coveringthe development, implementation& training on Policies and SOPs in 40+emergingMarkets.

Prior to takeda, Leonardo worked forMerck,Sharp&Dohme(MSD)(formerlySchering-Plough/Organon) in Brazil andselect LataMoperations such asCentralamerica,andnorthSouthamerica,aswellasmultiplesecondmentstothegloballawdepartmentinNJ,USa.

HeholdsamasterdegreeinlawfromtheLondonSchoolofeconomicsandPoliticalScience – LSe - University of Londonand is a licensed attorney-at-law for thejurisdictionofBrazil.

MeLteMOzKeRGUNDUznovo nordisk, turkeyLegal affairs & Compliance Director business area near East (banE)

Meltem Ozker Gunduz, born in turkey,based in Istanbul. Graduated fromGalatasaray University Law Faculty. HerLL.M studies are ongoing in IstanbulUniversity with focus on employmentLaw. Worked in Istanbul and LondonOfficesofHergunerBilgenOzekeattorneyPartnership until 2010, after then joinedNovoNordiskBusinessareaNeareast in

2010 with responsibility for managinglegal and compliance issues in turkey,Iran, Iraq, Israel, Jordan, Lebanon, Syria,Pakistan, afghanistan, Ukraine andMoldova. She is currently Legal affairs&ComplianceDirector inNovoNordiskBusiness area Near east and she speaksturkish,englishandFrench.

milada BraBcova eli lilly Compliance Director

MiladaBrabcovahasbeenaComplianceDirectorfortheCzechRepublicandSlovakiain eli Lilly since 2007. In

her role she leads an implementation ofthe compliance programme with themain focus on ethical interactions, anti-corruption and privacy. as a memberof Compliance and transparencyWorkingGroupsintheCzechandSlovakIndustryassociations(aIFP)shehasbeeninvolved in a local implementation ofeFPIa transparency disclosures. Miladahas 18 years of experience working inthe pharmaceutical industry in severalpositionsincludingsalesandmarketingasaNational SalesManager, eli LillyCzechRepublic.MiladagraduatedasaMasterinBiologyandChemistryandsubsequentlyobtained a Doctoral Degree in NaturalScience at Charles University in Prague.She holds a Master Degree in Businessadministration (MBa) from the OpenUniversity Business School in the UnitedKingdom(MiltonKeynes).

MaRCeLaKIRBeRGeR

sandoz, Germany global Head of Compliance

Marcela was appointedGlobalHeadofCompliancereporting operationally to

ShannonthymeKlingerand functionallyto ericCornut,Chief ethics,ComplianceandPolicyOfficerinJulyof2014.MarcelaisbasedinHolzkirchen,Germanyandisamemberof the Sandoz Legal Leadershipteam (SLLt) and the ComplianceLeadership team (CLt). In this position,Marcela is responsible formanagingandcoordinatingallintegrityandcompliancemattersforSandozglobally.

Marcela joinedNovartis in2006andhasworked for different Novartis divisionssince, assuming positions of increasingresponsibility. In 2012, she assumed theposition of Lead Counsel to the PrimaryCare and establishedMedicines BusinessUnit at NPC (Novartis PharmaceuticalsCorporation) where she provided legaladvice forallBUmatters. Before joining

Novartis,MarcelawasaSecuritieslitigatoratLowensteinSandler inNewJerseyandprior to that shehelda judicialclerkshipfor the New Jersey appellate Division. Marcela was born in Buenos aires,argentinaandreceivedalawdegreefromtheCatholic University of argentina andlateralawdegreefromtheRutgersSchoolofLawinNewark,NewJersey.

MILeNaYaKIMOVaactavis, BulgariaDirector Ethics & Compliance – Central Eastern & South Eastern Europe

Milenaholds a lawdegree fromLondonSchool of economics, StrasbourgUniversityandapost–graduatedegreeinlawfromCollegeofeurope,Bruges.

CurrentlyMilena isaDirectorethicsandcompliance at actaviswith responsibilityfor managing the compliance programwithin the european region. She has anexperience as a lawyer with the whitecollar defense and antitrust practices ofUSlawfirms,basedinBrussels.MilenahasextensivelyadvisedontheapplicationofeUcompetitionandregulatorylawtothepharmaceutical sector, on the interplaybetween antitrust and intellectualpropertylawandonhowtocomplywiththeDataProtectionactwhentransferringdata overseas. She has also served as alegalofficerattheBulgariancompetitionauthority.

NeLINeDKOVa

Boehringer-ingelheim, austriaHead of Compliance & Ethics Central and Eastern Europe

Dr. Neli Nedkova iscurrently Head of

Compliance & ethics Central andeasterneurope.SheisresponsiblefortheimplementationoftheGroup’scorporatecompliance program and development,implementation and monitoring of theregional compliance program for theCee Region (19 countries): includingestablishing respective governancestructures, performing risk assessmentand due diligence, developing policiesand procedures, performing trainingand creating awareness, conductingprogram monitoring and internalinvestigations. She also coordinates thenetwork of subject-matter experts andlocal compliance officers in the regionand provides guidance and advice tothe management and all functions. Sheis a Member of the Global ComplianceLeadership team and Global SubjectMatterexpertforanti-corruption.



NINA STOECKEL merck kGaa, GermanyDirector, Head of group Compliance Programs LE-CP

Nina is currently DirectorGlobal Compliance

Program, where she is responsible forstrategicdevelopmentandimplementationof the effective Compliance programand organization for all business sectorsof the Merck companies, as well as forthe maintenance of the Complianceframework and conducting complexCompliance projects. Between 2009and 2014, she held variety of positionswiththe increasingresponsibilities intheethicsandcomplianceareaatBoehringerIngelheim. Ninastartedherprofessionalcareer in 2000 as an In-house lawyerand project manager at Media-GroupSuddeutscherVerlag,whereshebecameamemberofthecomplianceteamin2007.

Nina completed her Law studies atRuprecht-Karls-Universitat Heidelberg,Germany in 1998. In 2008, she gainedher Master of Laws, completing herpostgraduate studies “InternationalBusinessLaw”attheUniversityofappliedSciencesMainz.

NICOLAS GIANNAKOPOULOSGlobal risk Profile, switzerlandFounding Partner

Nicolas Giannakopoulos isan internationally recognized expert incrime-related issues, including criminalrisks inherent to the public and privatesectors.

after completing a Ma in PoliticalScience from University of Geneva, Mr.Giannakopouloshascarriedoutnumerousresearch projects on behalf of largeinstitutions.

Hewasnotablyinchargeofathree-yearresearch program on corruption andorganizedcrime inSwitzerland,financedbytheSwissConfederation.

In2010,Mr.GiannakopouloscofoundedGlobal Risk Profile – a Swiss companyprovidingDuediligenceservices.

Lecturer at the University of Geneva, heis regularly called upon to intervene invariousconferences,someataministeriallevel.

PaULMeLLINGBaker & mckenziePartner

Paul Melling is an englishsolicitor and the foundingpartner of Baker &

McKenzie’s Moscow office (he is alsofounding partner of the Firm’s almatyoffice).HefirstjoinedBaker&McKenzie’sLondon office in February 1980, asa member of the Firm’s east-Westtrade Department, specializing in theCOMeCON countries of eastern europeand particularly the USSR. He took upresidenceinMoscowinJanuary,1989andhasspentover27yearsasapartnerintheCIS.

Mr.Melling is the founder of and leadsthe pharmaceuticals and healthcareindustry practice in Russia/CIS and isa Steering Committee member of theFirm’sGlobalandeMeaPharmaceuticals/HealthcarePracticeGroups.For22yearshe has been Honorary Legal adviser inRussia to theassociationof InternationalPharmaceuticals Manufacturers (aIPM).He has also been the Honorary Legaladviser to the British ambassador inMoscow since1990.and is amemberoftheadvisoryCouncilof theRusso-BritishChamberofCommerce.

Mr. Melling also leads the compliancepractice intheFirm’sCISofficesand isaSteeringCommitteememberoftheFirm’seuropeanCompliancePracticeGroup.HeisamemberoftheInternationalBusinessLeaders Forum’s International advisoryCouncil for Russia and amember of theLeadershipGroup for IBLF’s “ImprovingBusiness Standards in Russia Initiative”.In 2013 he was appointed to Russia’s B20taskForceontransparencyandanti-Corruption.

In 2009 Mr. Melling received theDistinguished Service award fromaIPM for “Outstanding Contributionto the Development of the RussianPharmaceuticalsMarket”.



Corporate Compliance & Transparency in the Pharmaceutical Industry

Health & Medicine

Transcript of Corporate Compliance & Transparency in the Pharmaceutical Industry