Global Transparency Reporting Congress

1. CBI, a division of
UBM Life Sciences
REGISTER AT WWW.CBINET.COM/GLOBALTRANSPARENCY • +1 339-298-2100
MEDIA PARTNERS:
Global Transparency
Reporting Congress
6th Annual
Evolving Guidelines for Disclosing HCP Spend Across the Globe
7-8 April 2016 • Hilton Frankfurt • Frankfurt, Germany
R EG I S T E R B Y 5 F E B R U A RY 2 01 6 A N D S AV E € 2 5 0 !
Bruno Borde,
R&DTransparency Officer,
Sanofi (France)
Progressive Insights from ExperiencedTransparency
Reporting Professionals
Andrew Powrie-Smith,
Director of Communications,
European Federation of
Pharmaceutical Industries and
Associations (EFPIA) (Belgium)
Silke Ryan,
Senior Business Consultant,
GlobalTransparency,
Lilly Deutschland GmbH
(Germany)
Edyta Banach,
Regional Head of
Ethics & Compliance,
Abbvie (Poland)
Ekaterina S. Walloe,
Competency Development Manager,
HCP Compliance, Medical Anchor,
Global Development,
Novo Nordisk A/S (Denmark)
Rajesh Chavan,
Global Xpend –
US Cross Border Lead,
Novartis Pharma AG
(Switzerland)
Peter Herrmann,
Group Compliance Officer,
Head Corporate Affairs
and Compliance,
Actelion Pharmaceuticals Ltd.
(Switzerland)
Dr. Marcel Koerting, LL.M.,
Senior Legal and Compliance
Counsel, Strategic Operations
Europe, Novo Nordisk
Health Care AG (Switzerland)
Andriy Kirmach,
EAME Compliance &
Ethics Manager,
Allergan Holdings Limited
(United Kingdom)
Dr. Holger Diener,
Managing Director,
Association ofVoluntary
Self-Regulation for the Pharmaceutical
Industry “FSA” (Germany)
Karen Borrer,
Head of Reputation,
The Association of the British
Pharmaceutical Industry (ABPI)
(United Kingdom)
Jeroen Van Impe,
Senior Manager External
Reporting &Transparency EMEAC,
Health Care Compliance & Privacy,
Johnson & Johnson EMEA
(Germany)

2. REGISTER AT WWW.CBINET.COM/GLOBALTRANSPARENCY • +1 339-298-2100
Conference Sponsors:
A Great Place to MeetYour Market!
Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating
thought leadership and sharing expertise. For more information on how to position your company as a sponsor or
exhibitor, contact Alexa Moore at +1 339-298-2107 or email alexa.moore@cbinet.com.
With the June 2016 deadline for publishing transfers of value to HCPs and HCOs
approaching, there is not a better time to convene and discuss the current EFPIA
Disclosure Code implementation progress and the challenges yet to overcome.
CBI’s 6th Annual GlobalTransparency Reporting Congress is the gold standard
to gain key insights from EFPIA, ABPI, FSA, INFARMA, compelling case studies, expert
panels and interactive discussions dedicated to progress in transparency reporting.
WHO SHOULD ATTEND:
You will benefit from attending this event if you are working in life sciences and have responsibilities or
involvement in the following areas:
Compliance/ Legal/Ethics • Transparency/Reporting • Commercial/Business Operations
Medical/Regulatory/Clinical Affairs • Systems/IS/IT
HCP Engagement/Relations • Project/Program Management
This conference will also benefit consultants, technology vendors and companies providing
services to the above audience.
• Identify the best process and system
configurations for collecting and
maintaining master data, as well as ensuring
completeness of payment registrations
• Discuss the outlook for the
June 2016 publishing date and post
disclosure issue management
• Learn about the differing applicability of
the EFPIA code within countries depending
on diverse factors (law vs. code, culture,
tools, type of organisations and challenges)
• Discover the most common problems
at this stage of implementation
including reporting cross-border
activities and payments
• Assess and reduce compliance risks
involved with managing HCP payments
• Applicable lessons from German
companies who have already disclosed
their data
• Examine levels of consent across
Europe in countries where consent is
applicable. What does the trend look like?
• Hear about HCP concerns regarding
publication of the spend data and consider
what may happen when consent is recalled
• Establish a “transparent” method for
determining Fair Market Value
• Gain an update on the design,
development and delivery of the
UK disclosure project
• Understand critical EFPIA-US
cross-border reporting concerns

3. 12:00 Main Conference Registration
13:15 Chairman’s Welcome and Opening Remarks
PeterHerrmann,GroupComplianceOfficer,HeadCorporateAffairsand
Compliance,Actelion Pharmaceuticals Ltd. (Switzerland)
Regulatory and Industry Update on
Implementation of the EFPIA Disclosure Code
13:30 EFPIA KEYNOTE
Insight into the Implementation of EFPIA
Disclosure Code and Plans for Publication
Gain an update on the implementation of the
EFPIA Disclosure Code on Transfers of Value from
pharmaceutical companies to HCP/HCOs.
• Challenges uncovered, to date, on implementing the
disclosure code
• Progress and outlook for the June 2016 publishing date
• Recommended best practices for implementing
EFPIA’s code
• Frequently asked questions regarding EFPIA templates
and other issues
• Suggestions for post disclosure issue management
AndrewPowrie-Smith,DirectorofCommunications,
European Federation of Pharmaceutical Industries
and Associations (EFPIA) (Belgium)
14:15 Real-life Implementation of the EFPIA
Disclosure Code
Hear results of a survey on the practical implementation
of transparency processes according to the EFPIA code.
• Collect information, by survey, regarding what
companies consider as best practices for disclosure
REGISTER AT WWW.CBINET.COM/GLOBALTRANSPARENCY • +1 339-298-2100
Workshop Objective:
The success of your transparency reporting initiatives and
overall compliance program depend on the effectiveness
of your process and systems for collecting and managing
complete and accurate data. This workshop provides key
takeaways and best practices for successfully managing the
customer master, as well as, ensuring the quality of data
collection and systems for all related HCP payment transactions.
Key Questions to Be Addressed:
• How much should you invest in consolidating and perfecting
customer master data?
• What are the best processes and system configurations for
collecting and maintaining master data?
• What are the recommendations for how to ensure the
completeness of payment registrations?
Workshop Outline:
I. Key Learnings on Various Approaches to
Successfully Managing Master Data
• Tips for consolidating master data
• Levels of investment in master data and related ROI
• Strategies for collecting and maintaining complete
and accurate data
II. Ensuring Completeness of
Payment Registrations
• Understand EFPIA categories for reporting and
how others are splitting payments into EFPIA
categories to ensure payment for the correct entity
• Flagging data that flowed through without being
captured and setting up controls to prevent from
happening in the future
• Payment documentation — Ways to link payment
details for the HCP to the invoice
III. Safeguarding Accuracy at Local and
Global Levels
• Identifying opportunities to streamline capture
procedures across borders and affiliated organisations
• Implementing processes and systems to handle
data management and reporting locally, regionally
and globally
• Strategies for data remediation, potential
standardisation and validation
There will be a 30-minute networking and refreshment break at 10:00 a.m.
12:00 Close of Pre-Conference Workshop
Workshop Leaders:
EkaterinaS.Walloe,CompetencyDevelopmentManager,HCPCompliance,
MedicalAnchor,GlobalDevelopment,Novo Nordisk A/S (Denmark)
Ms.WalloehasbeenwithNovoNordisksince2007.Mrs.WalloestartedinIT&Corporate
DevelopmentandmovedtoProductSupplyandthentoClinicalDevelopmentwithHCP
ComplianceCoordinatorresponsibilitiessinceMarch2012.ShehasbeentheCompetency
DevelopmentManagersinceSeptember2014withHCPComplianceresponsibilitiesforGlobal
DevelopmentandsinceSeptember2015withHCPComplianceresponsibilitiesforR&D.
JonasWellendorph,TeamLeaderHCPOffice,BusinessEthicsCompliance,
Novo Nordisk A/S (Denmark)
Mr.WellendorphisheadinguptheHCPofficeatNovoNordiskHeadquarterinDenmark.
TheHCPOfficewasestablishedin2010responsibleforensureglobaltransparencywithin
theglobalorganisationandensuringstandardisedprocessesandtoolsforcrossborder
engagements.Throughoutthelastfiveyears,hehasbeeninvolvedinallmajorcompliance
implementationsatNovoNordisk,U.S.Sunshineact,FranceBertrandLawandtheEFPIAcode.
AnnikaVallaBroman,SeniorCorporateCounsel,Novo Nordisk A/S (Denmark)
Ms.BromanisworkingasSeniorCorporateCounselinNovoNordiskA/S'PharmaLawTeam.
SheisresponsibleforsupportingGlobalDevelopmentwherehermainfocusisclinicaltrials
andHCP-relatedtasks,includingtransparencywork.BeforejoiningNovoNordiskA/S,shehas
workedinDanishprivatelawfirmwhereshewasalegaladvisorfortoptierpharmacompanies.
Ms.BromanhasalsoworkedasaLegalConsultantintheDanishAssociationofthePharmaceutical
IndustryandwithpublicadministrationattheDanishMinistryofHealth.
7:30 Workshop Registration and Continental Breakfast • 8:30 Workshop Leaders’ Welcome and Opening Remarks
DAY ONE THURSDAY, 7 APRIL 2016
PRE-CONFERENCE WORKSHOP
Ensuring the Accuracy and Completeness of Customer Master
andTransaction Data
M A I N C O N F E R E N C E

4. • Learn about the differing applicability of the
EFPIA code within countries depending on
diverse factors (law vs. code, culture, tools, type of
organisations and challenges)
• Identify the most common problems at this state of
implementation including reporting cross-border
activities and payments
MODERATOR:
BrunoBorde,R&DTransparencyOfficer,Sanofi (France)
PANELISTS:
EkaterinaS.Walloe,CompetencyDevelopmentManager,HCPCompliance,
MedicalAnchor,GlobalDevelopment,Novo Nordisk A/S (Denmark)
HelenGevrey,Director,EFPIAImplementationTeamLeader,
GlobalCommercialOperations,Pfizer (France)
KrzysztofKaluzny,ProjectManager,INFARMA (Poland)
15:00 The Latest Transparency Disclosure
Guidelines Around the World
Benefit from an excellent summary of the latest
developments in transparency reporting around the world.
• Europe
• Asia Pacific
• Latin America
• Updates from medical device and generic industries
BrianSharkey,VicePresident,
Porzio Life Sciences (United States)
ChristineBradshaw,VicePresident,
Porzio Life Sciences, LLC (United States)
15:45 Networking and Refreshment Break
16:15 EFPIA Reporting — Getting Ready for
Disclosure through a Global Approach
The importance of building integrated business process
and systems to enable a global framework for managing
transparency data has never been greater.
• Understanding current local business processes,
systems being utilised and current state business
activities leading to disclosable transactions
• Identification of key data fields needed for proper data
collection and potential existing gaps
• Assessing the feasibility of, and developing a global
strategy, to move from varying business processes and
systems to an integrated approach
• Obstacles and successes in implementing consistent
business processes and systems to enable accurate
data capture and reporting — Meeting management,
as an example
• Translating requirements into business processes while
enhancing customer experience
SilkeRyan,SeniorBusinessConsultant,GlobalTransparency,
Lilly Deutschland GmbH (Germany)
17:00 Enhance Data Monitoring, Auditing and Risk
Assessment to Improve Compliance Programs
• Assess and reduce compliance risks involved with
managing HCP payments
• Understand how data monitoring and auditing feed
successful transparency programs
• Discover ways to structure the process for documenting
HCP payments and ensuring that documentation is
easily accessible
EdytaBanach,RegionalHeadofEthics&Compliance, Abbvie (Poland)
17:45 Close of Day One
Networking, Wine and Cheese Reception
immediately following the final session on day one
DAY TWO
FRIDAY, 8 APRIL 2016
7:30 Continental Breakfast
8:00 Chairman’s Review of Day One
PeterHerrmann,GroupComplianceOfficer,HeadCorporateAffairsand
Compliance,Actelion Pharmaceuticals Ltd. (Switzerland)
Develop and Implement Strategies for
HCP Relationship Management
8:15 Understand the Transparency Reporting
Experience in Germany
Gain an update on transparency reporting in Germany
two months before the end of the first publication period.
• Applicable lessons from German companies who have
already disclosed their data
• Examine the figures and the press reactions
Dr.HolgerDiener,ManagingDirector,
Association of Voluntary Self-Regulation for
the Pharmaceutical Industry “FSA” (Germany)
9:00 Examine Varying Approaches to Attaining
HCP Consent Management
Managing the relationship with HCPs regarding consent to
disclose is one of the most critical aspects to your successful
transparency compliance programme. Participate in a
debriefing on 2015 consent management efforts.
• How has the consent management process worked
so far?
• Who has received more consent? How did you go
about it?
• Understanding simple solutions (low cost) versus
complete consent solutions (high cost)
• What initiatives are companies taking to get HCPs
on board?
• Where does EFPIA stand on this issue?
• How is consent being collected and documented?
• Looking at levels of consent across Europe in countries
where consent is applicable
> what does the trend look like?
> what is the expected impact of low consent levels?
> what are local industry associations doing about it?
PANELISTS:
Dr.MarcelKoerting,LL.M.,SeniorLegalandComplianceCounsel,
Strategic Operations Europe, Novo Nordisk
Health Care AG (Switzerland)
SilkeRyan,Consultant,GlobalTransparency,
Lilly Deutschland GmbH (Germany)
JeroenVanImpe,SeniorManagerExternalReporting&Transparency
EMEAC,HealthCareCompliance&Privacy,
Johnson & Johnson EMEA (Germany)
9:45 Informing HCPs Prior to Disclosure and
Planning for Error Remediation
This panel is an opportunity to debate the benefits of
pre-disclosing spend data to HCPs prior to publication.
• Establish communication strategies for HCP
relationship management
• Consider approaches for managing questions from
HCPs about the data both pre and post disclosure
REGISTER AT WWW.CBINET.COM/GLOBALTRANSPARENCY • +1 339-298-2100
P
A
N
E
L
P
A
N
E
L
P
A
N
E
L

5. • Hear about HCP concerns regarding publication
of HCP spend data and the process of obtaining
consent management
• What happens when consent is recalled?
• Approach to pre-disclosure — Are companies
generally requesting validation/acknowledgement
of transactions by recipients prior to disclosure in line
with EFPIA best practice guidance? If so, how? Are they
including the ability to update consent status in this
communication with the recipient?
MODERATOR:
JohnPatrickOroho,ExecutiveVicePresident&ChiefStrategyOfficer,
Porzio Life Sciences, LLC (United States)
PANELISTS:
AoifeDelmas,HeadoftheESCIndustryRelationsDepartment,
ESC-European Society of Cardiology (France)
MichelBallieu,CEO,European CanCer Organisation (Belgium)
JonasWellendorph,TeamLeaderHCPOffice,BusinessEthicsCompliance,
Novo Nordisk A/S (Denmark)
10:30 Networking and Refreshment Break
Operationalise Methods for Successful
Transparency Programs
11:00 Choose From Two Concurrent
Working Groups (A & B)
A Establish a “Transparent” Method for
Determining Fair Market Value
Consider the criteria for setting your process for
establishing a global FMV policy to remain consistent
with national and international reporting regulations.
• Communicate a transparent methodology for how
HCPs are paid
• How to use submitted transparency data to evaluate
and improve FMV
• Integrate global considerations into your FMV
calculations
UlfGrundmann,Partner,King & Spalding (Germany)
B What to Expect When Disclosure Goes “Live”
Gain insight from colleagues on plans for managing the
reaction to the data when it is disclosed in 2016.
• How ready are we for the June 2016 EFPIA publication
of HCP payment data?
• Evaluation of level of readiness on the following:
> systems
> resources
> processes
• How well is the transparency programme integrated
with local and headquarter offices?
• What to expect when disclosure goes live?
• What course to follow in the event of false disclosure?
AndriyKirmach,EAMECompliance&EthicsManager,
Allergan Holdings Limited (United Kingdom)
11:45 Choose From Two Concurrent
Working Groups (C & D)
C Managing Cross Border Activities and
HCP Interactions
• Discuss potential FCPA stemming from
cross border activities
• Implement compliance initiatives to safeguard
against anti-corruption
RajeshChavan,GlobalXpend–USCrossBorderLead,
Novartis Pharma AG (Switzerland)
D Overcome the Pitfalls Involved in
Working with Third-Parties
Learn more about how to manage
third-parties successfully.
• Conducting due diligence with third-parties and
managing the inherent risks of the relationship
• How to qualify and train third-parties, ensuring that
they are on board with your processes
• Ways to ensure completeness of third-party spend,
including auditing spend data and underlying
processes/systems
AlexandraGray,Transparency&Monitoring,AssociateDirectorEMEABusiness
Conduct,Gilead Sciences Europe Ltd. (United Kingdom)
12:30 Luncheon
13:45 ABPI Featured Address — Remote Presentation
An update on the design, development and delivery of
the UK disclosure project as the pharmaceutical industry
across Europe prepares to make public transfers of value
to individual healthcare professionals and healthcare
organisations in June 2016.
KarenBorrer,HeadofReputation,
The Association of the British Pharmaceutical
Industry (ABPI) (United Kingdom)
14:30 EFPIA-US Cross-Border Reporting Concerns
EFPIA and the United States are one of the most common
cross-border reporting concerns. Compare and contrast
the EFPIA-US reporting expectations.
• Examine cross border engagements involving HCPs
• Identify areas of high risk
• Compare and contrast main areas of reporting
requirements
• Benefit from an explanation for exactly where
EFPIA requirements are most different to U.S. Open
Payments Reporting requirements
RajeshChavan,GlobalXpend–USCrossBorderLead,
Novartis Pharma AG (Switzerland)
15:15 Close of Conference
REGISTER AT WWW.CBINET.COM/GLOBALTRANSPARENCY • +1 339-298-2100

6. WEBSITE
www.cbinet.com/
globaltransparency
EMAIL
cbireg@cbinet.com
PHONE
800-817-8601
339-298-2100 outside the U.S.
LIVE CHAT
www.cbinet.com/
globaltransparency
WAYS TO REGISTER NOW!
SCAN HERE
CBI
70 Blanchard Road
Burlington, MA 01803
6th Annual GlobalTransparency Reporting Congress PC16105
VENUE:
Hilton Frankfurt
Hochstrasse 4
60313, Frankfurt am Main, Germany
Phone Reservations: 00800 888 44 888
Hotel Direct Line: +49 69 133800
For U.S. Residents: 1-800-445-8667
PLEASE NOTE: All hotel reservations for this conference should be booked
directly with the hotel. CBI does not use Housing Bureaus and none are
authorised to call on our behalf.
Hotel Cancellation Information: To avoid penalty, you may cancel your
room reservation up to 28 days prior to the arrival date. After that date rooms
are non-refundable.
ACCOMMODATIONS:
To receive CBI’s special discounted hotel rate online or by phone, please go to:
• Online: www.cbinet.com/globaltransparency
• Phone reservations: 00800 888 44 888 and mention CBI’s Global Transparency
For U.S. Residents: 1-800-445-8667
Book Now! The Hilton Frankfurt is accepting reservations on a space and rate availability basis.
Rooms are limited, so please book early. All travel arrangements subject to availability.
REGISTRATION FEE:
ADVANTAGE PRICING Standard Onsite
Conference + Workshop €1950 + 19% VAT tax €2200 + 19% VAT tax €2300 + 19% VAT tax
Conference Only €1650 + 19% VAT tax €1900 + 19% VAT tax €2000 + 19% VAT tax
Register by 5 February 2016 and SAVE €250. Fee includes continental breakfast, lunch,
wine and cheese reception, refreshments and conference documentation. Please make checks
(in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)
PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.
GROUP RATE:
Looking to bring your team? Contact customer service to learn out about potential group savings.
Call +1 339-298-2100 or email cbireg@cbinet.com.
* Advantage pricing rates do apply when applicable. Offer may not be combined with any other
special pricing promotions. Offer may be used at CBI co-located events.
SATISFACTION GUARANTEED:
CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference,
a credit will be awarded towards a comparable CBI conference of your choice. Please contact
+1 339-298-2100 for further information. Advanced preparation for CBI conferences is not required.
SUBSTITUTION AND CANCELLATION:
Your registration may be transferred to a member of your organisation up to 24 hours in advance of the
conference. Cancellations received in writing on or before 14 days prior to the start date of the event
will be refunded, less a $399 administrative charge. No refunds will be made after this date; however,
the registration fee less the $399 administrative charge can be credited to another CBI conference if
you register within 30 days from the date of this conference to an alternative CBI conference scheduled
within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the
conference registration fee only. CBI reserves the right to alter this program without prior notice. Please
Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort
to find a suitable replacement will be made without notice. The opinions of the conference faculty do
not necessarily reflect those of the companies they represent or CBI.
R EG I S T E R B Y 5 F E B R U A RY 2 01 6 A N D S AV E € 2 5 0 !
REGISTER AT WWW.CBINET.COM/GLOBALTRANSPARENCY • +1 339-298-2100
CBI, a division of
UBM Life Sciences
Global Transparency
Reporting Congress
6th Annual
Evolving Guidelines for Disclosing HCP Spend Across the Globe
7-8 April 2016 • Hilton Frankfurt • Frankfurt, Germany
ANY QUESTIONS OR TO REGISTER
CONTACT: Juliet Nelson
phone 339-298-2140
fax to my attention 781-939-2694
email juliet.nelson@cbinet.com