3rd corporate compliance & transparency in pharma
DESCRIPTION
Corporate Compliance & Transparency in Pharma ZurichTRANSCRIPT
25th – 26th February 2015, Zurich, Switzerland
Who Will you meet?
Ethics and Compliance Officers General Counsel Vice Presidents and Directors of:
Corporate Responsibility
International Contracts
Corporate Compliance
Legal Affairs
Internal Audit
Business Conduct
Transparency Operations
Private practice lawyers specialising in:
Corporate Governance
International Regulation & Compliance
White Collar Crime
Investigations
Life Sciences
Pharmaceuticals
What Will you hear about?
EFPIA disclosure requirements
Change Management - How to prepare your team for transparency
Defining a transparency framework: Local vs. regional vs. global
The human side of compliance: communication, training and talent management
How to prevent corruption in your organisation
The challenges in emerging markets and their impact in Europe
Review tools and techniques for assessing risk posed by third parties
For further information please contact:
Cristina mendoza / Senior Conference ProducerPhone No.: + 421 257 272 193 email: [email protected]
www.flemingeurope.com
3rd AnnualCorporAte CompliAnCe
& trAnSpArenCy in the pharmaceutical industry
our SPeaker PaNel:
riChard bergStröm eFPia, Director General
katríN FjeldSted, CPme (Comité PermaNeNt deS médeCiNS euroPéeNS - StaNdiNg Committee oF euroPeaN doCtorS) President
kerSteN SChmahl aCtaviS, Vice President, Ethics & Compliance Europe and MEAAP
klauS geldSetzer, SaNteN Chief Compliance Officer Europe
ole WeNdler PederSeN Novo NordiSk, General Counsel Region Europe Director Legal, Compliance & Business Development
SWee kheNg khor, abbvie Associate Director Office of Ethics and Compliance Middle East and Pakistan
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 Compliance Officer
StePheN NguyeN-duC abbvie euroPe, Office of Ethics & Compliance Director TBC
www.flemingeurope.com
our exPert adviSory board:
klauS geldSetzer Chief Compliance Officer Europe Santen (germany)
milada brabCova Compliance Director eli lilly (Czech republic)
SWee kheNg khor Associate Director Office of ethics and Compliance middle east and Pakistan abbvie (united arab emirates)
giaN luCa triNei Chief Compliance Officer Pfizer (italy)
jörg voN maNger-koeNig, Executive Vice President Legal and Compliance & Group General Counsel, Nobel biocare (germany)
hal glaSSer Former Senior Director Chief Ethics & Compliance Officer Sanofi Pasteur mSd (France)
For further information please contact:
Cristina mendoza / Senior Conference ProducerPhone No.: + 421 257 272 193, Email: [email protected]
eveNt iNtroduCtioN
Transparency requirements are taking on global dimensions. There has been a push for public transparency over the past decade of interactions between the pharmaceutical and life sciences industries and healthcare professionals and organisations. Government authorities and voluntary self-regulatory industry groups assert that enhancing the transparency of these interactions will promote compliant behavior and thus mitigate potential conflicts of interest. Transparency and disclosure requirements have generally been country-specific, focusing primarily on payments and transfers of value to HCPs and HCOs licensed by or located within a specific country. However, the industry has begun to develop initiatives to harmonize transparency and disclosure requirements across geographic borders.
This conference will serve as a platform to discuss compliance and transparency areas of key concern. Discuss with leading speakers disclosure requirements, do‘s and don‘ts when defining a transparency framework, how to prevent corruption, the challenges in emerging markets, how to monitor third parties, etc. Do not hesitate, take this great networking opportunity and join us in Zürich!
DAy 1 | 25th FEBRuARy 2015
8:30 REGISTRATION COFFEE
9:00 WELCOMING NOTE FROM FLEMING EuROPE
9:05 OPENING REMARkS FROM THE CHAIR
9:10 eFPia – disclosure requirements
• AnalysingbestpracticetomaintaintheEFPIAcodeleading up to 2016
• Whathasthefeedbackbeensofar?• Enhancingcooperationtoachievetransparency• ExpectedimpactonfuturerelationshipswithHCPsand
on the industryRiChaRD BERGstRöm, eFPia, Director General
9:40 What the Pharma industry really had to do When getting ready for transparency
• Fromconcepttopractice–theactualimpactontheindustry
• Communicationapproachestoprofessionalsocietiesand/or public to explain transparency requirements
• Reportingobligationsforcompanies• ObtainingconsentfordisclosureofdatafromHCPs• Whattodoifconsentisnotobtained?OlE WEnDlER PEDERsEn, Novo NordiskGeneral Counsel Region Europe Director Legal, Compliance & Business Development
10:10 MORNING COFFEE & NETWORkING
10:40 the ‚Customer‘ Perspective and their Concerns - hCPs/hCos and the disclosure requirements
• Howdoesthemedicalcommunityperceivethecode?• WhatobligationsareimposedonHCPswithregardsto
reporting?• Whatistheimpactinthemedicalcommunity?KatRín FjElDstED, CPme (Comité Permanent des médecins européens - Standing Committee of european doctors)President
11:10 the legal Perspective – the Challenges of data Protection
The EFPIA Code has raised data protection issues as HCP names and affiliations are recognised as personal data, and, throughout Europe, data protection laws set out roughly the same conditions regarding the use of personal data. In this session we will take a closer look at the interaction of transparency and data protection rules in Europe and address what steps pharmaceutical companies need to take to ensure they remain compliant.
11:40 transparency driven by legislation
• DistinguishingbetweentheEFPIAtransparencycodeasa “voluntary scheme” and specific legal obligations
• Howbusinessmodelshavechangedjurisdictionsimpacted by transparency legislation
• WhatnewwaysofcooperationhaveemergedbetweenindustryandHCPs?
12:30 LuNCH
13:30 braiNStormiNg SeSSioN – defining your transparency vision: local vs. regional vs. global
To boost interactivity and networking, the audience will break into smaller groups. Each table will have the opportunity to discuss for 30 minutes the different approaches and weigh the do‘s and don‘ts when defining a strategy to address transparency.
• Whatarethedo‘sanddon‘tswhenimplementinglocal,regional,orglobalapproachestotransparency?
• Whatisrightlevelofgovernance,collaborationandvisibilityintermsofHCP/HCOspendacrosstheEU?
• Wichcountry-specificcompliancepoliciesandprivacylaws would influence tracking and reporting cross-borderspend?
14:30 Change management: establishing a Compliant and ethical Culture
Organisational change directly affects all departments from the entry level employee to senior management. The entire company needs to learn how to handle changes to the organisation. Research, surveys and experience have shown that much, if not most, of the resistance to a change can be eliminated through appropriate action:• Howtoimplementchangemanagementtoachieve
compliancesanGEEtha KaRPORE KumaR, DR.reddy‘s laboratories, associate directorCompliance Head Emerging Markets
15:00 Setting up an effective anti-Corruption and anti-bribery Programme
• Determiningwhetheryourprogrammeworksinpractice
• Establishingcohesivereportingmechanisms• Whichfunctionsintheorganisationshouldbeinvolved
tohelpmitigatecorruptionrisks?• Determiningthemostappropriatecompliance
structure: centralised vs. local/regional• Theroleofdatacollectioninidentifyingriskand
exposures
15:30 AFTERNOON TEA & NETWORkING
16:00 the rare but Far-reaching Whistleblower: a tool to detect Corruption
• Internalvs.thirdpartyalertlinesolutions• Privacyandwhistleblowerprogrammes• Whenshouldyourespondtothewhistlebeingblown
internally?• Establishinganadequateinvestigationmanualand
procedures• Cooperationwiththeauthorities
16:30 analysing best Practices to establish a Compliance road-map
• Strengtheningcommunicationfromtoptobottom• Optimisingcollaborationbetweencomplianceand
other departments• Whatarethetoolsavailabletomanageinternal
processes?• Howtoensurethatcomplianceisapowerfuland
respected partner for the business• Trainingbestpracticestocopewiththecurrent
environment
17:00 Compliance as a developing discipline in europe
• ComplianceasadevelopingdisciplineinEurope• Whatmakesagoodcomplianceofficer?Whatarethe
requirements?• Empoweringtheroleofthecomplianceofficer
to embed compliance effectively within business operations
• Howdoyoutrainyourowncomplianceofficers?tOmasz KRuK, mallinckrodt PharmaceuticalsDirector International Compliance
17:30 CLOSING REMARkS FROM THE CHAIR
Speakers and delegates are cordially invited to attend a Networking Cocktail Reception
booking line: tel: +36 1 411 1929, fax: +36 1 411 1841
email: [email protected], www.flemingeurope.com
DAy 2 | 26th FebruAry 2015
9:00 Welcoming note from the Chair
9:10 outside the box Presentation: lessons for the Pharmaceutical industry
What can the industry learn from other industries‘ complianceprogrammes?E.g.tobacco,mining,banking, etc.
9:40 best Practices for managing and monitoring third Parties
• EvaluationandmonitoringactivitiestoconfirmThirdParties’ compliance with the required standards
•Determiningwhatinformationandduediligenceisrequired according to the type of third party
• Assessingourthirdparty‘sawarenessofcorruptionand other risks and company‘s compliance practices
naDER KhEDR, SandozHeadRegionalCompliance–MEA
10:10 handling third Parties‘ risk
•Whatarethestrategiesandtoolsavailabletoassessrisk?
•Whatarethehighriskthirdparties?
•Whatarethewarningsignsinthecooperationwiththirdparties?
KERstEn sChmahl, actavis Vice President, Ethics & Compliance - Europe and MEAAP
10:40 morning coffee & networking
11:10 enhancing Collaboration with third Parties
• Buildingpartnershipswiththirdpartiesthatareableto meet your requirements
• Supporteachotherthroughthedisseminationofknowledge, expertise, teaching and mentoring
11:40 the Cross-border effects of bribery and Corruption legislation
• ExtraterritorialapplicationofUSlawandUKAnti-Bribery law in other countries and regions
• Keyregionstargetedwheninvestigatingpharmacompanies
•Whatistheprofileofacompanyatrisk?
12:40 lunch
13:40 bridging regions: europe and emerging markets
•Overcomingculturalchallengesincross-borderimplementation of a compliance programme
• Keylegislativeprovisionsintheregionthatneedtobe considered
• Enhancingcooperationtoevaluateandmanageriskoperations
14:10 Spotlight Session: Compliance & transparency in emerging markets
an opportunity for experts to share their knowledge and experience with peers from different emerging regions and to discuss the challenges in managing corruption, risks and third parties.
•Overviewofpolitical,legalandregulatoryapproaches
•Understandingthelocalapproachwhenitcomestocorruption
•Howtohandlethekeychallengesintheregion
•Howtoshapetheexternalenvironmentintoanappropriate corruption-free climate for doing business
•Whatarethestrategiesfordealingwithunreliableandinaccessiblethirdpartiesinforeignjurisdictions?
•Howcanyouconducteffectiveduediligenceonthirdpartiesinemergingmarkets?
•Understandingandinvestigatingredflagsinordertoavoid improper payments
•Howcanyouensurethatyourmonitoringprogrammehaslocalrelevanceandefficacy?
sWEE KhEnG KhOR, abbvie,Associate Director Office of Ethics and Compliance Middle East and Pakistan
sanGEEtha KaRPORE KumaR, DR.reddy‘s laboratories, associate directorCompliance Head Emerging Markets
15:40 Q & a session
15:55 Closing remarks from the Chair
16:00 Farewell Coffee and Networking
I would like to thank everyone who provided assistance with the research and organisation of this event,
especially our expertadvisers and speakers.
Cristina Mendoza, Conference Producer
+ 421 257 272 193, [email protected]
booking line: tel: +36 1 411 1929, fax: +36 1 411 1841
email: [email protected], www.flemingeurope.com