corporate compliance & transparency in the pharmaceutical industry
TRANSCRIPT
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 HeadofComplianceðicsCentraland 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
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
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
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
CONFeReNCeDaY1|24thFeBRUaRY2016
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
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
CONFeReNCeDaY2|25thFeBRUaRY2016
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
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
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
CONFeReNCeDaY2|25thFeBRUaRY2016
applicationeNSURetHatYOURtIMeattHeCONFERENCE IS eFFeCtIVeaSWeLLaSFUN,WItHOURNeWONLINeEASILY ACCESSIBLE NetWORKINGaPP.
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Forfurtherinformationpleasecontact:
dasa janosikova
ProductionManagerLifeSciences
PhoneNo.:+421257272104 email:[email protected]
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
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.
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
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.
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events
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”.
Booking line: tel:+421257272155,fax:421255644490
email:[email protected],www.fleming.events