3rd corporate compliance & transparency in pharma

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Corporate Compliance & Transparency in Pharma Zurich

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Page 1: 3rd corporate compliance & transparency in pharma

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

Page 2: 3rd corporate compliance & transparency in pharma

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!

Page 3: 3rd corporate compliance & transparency in pharma

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

Page 4: 3rd corporate compliance & transparency in pharma

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