International Pharmaceutical Compliance Congress

1. R E G I S T E R B Y 1 2 S E P T E M B E R 2 0 1 4 A N D S AV E € 4 0 0 !
21-22 October 2014 • Renaissance Brussels Hotel • Brussels, Belgium
The Most Comprehensive and Strategic Event Dedicated to
Managing and Enhancing Your Global Compliance Programmes:
Customisable Content
Select sessions from the most pressing
legal and compliance challenges, including
R&D, monitoring, anti-bribery and corruption,
transparency reporting and more
Benchmark with Peers
Engage and interact with colleagues to gain a
thorough understanding of strategic solutions
and best practices to mitigate risk
Industry’s Leading Experts
More than 40 industry leaders round
out the esteemed speaking faculty,
set to deliver strategic insights and
applicable solutions
Code Update Spotlight
Interactive panel focused on current
reporting and code requirements
from EFPIA
Featured Faculty Members Include:
Michael Bartke, Ph.D.,
Director Compliance
Management,
Daiichi Sankyo
Europe GmbH
Brian Beeler,
Chief Compliance Officer,
Horizon Pharma
Richard Bergström,
Director General,
EFPIA (European
Federation of
Pharmaceutical
Industries and
Associations)
Garineh Dovletian,
Senior Vice President,
Chief Risk Officer
The Medicines Company
Marc-Olivier Lamaro,
Chief Compliance Officer,
Sanofi Pasteur MSD
Michael Parini,
Chief Litigation Officer,
Pfizer Inc
Jeffrey Rosenbaum,
Vice President,
Chief Compliance Officer,
Vertex
Kersten Schmahl,
Vice President,
Ethics and Compliance –
Europe and MEAPP,
Actavis
Media Partners:
CCO Summit Host:
Marc Christian Bauer,
Director, Senior Legal
Counsel/Rechtsanwalt,
Amgen International
Law Group
REGISTER AT WWW.CBINET.COM/INTERNATIONALCOMPLIANCE • +1-339-298-2100

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WE’VE GOT COMPLIANCE DOWN
Michael Bartke, Ph.D.,
Director Compliance
Management,
Daiichi Sankyo
Europe GmbH
TO A (GLOBAL) SCIENCE...
Global Transparency
Reporting Congress
THANK YOU TO OUR 2014 ADVISORY BOARD:
Garineh Dovletian,
Senior Vice President,
Chief Risk Officer,
The Medicines Company
Anja Verbeke,
Regional Compliance
Counsel – EMEA,
Baxter Healthcare
Joe Kent, BSC (HONS), MBA,
Chief Compliance Officer –
Europe & Canada,
Takeda Pharmaceuticals
International GmbH
CONFERENCE SPONSORS
A GREAT PLACE TO MEET YOUR 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 Taylor Biggers at +1-339-298-2108 | taylor.biggers@cbinet.com
or Jamie McHugh at +1-339-298-2106 | jamie.mchugh@cbinet.com.
West Coast
Compliance
Congress
Transparency
and Aggregate
Spend West
Device and
Diagnostics
Compliance
Congress
PCC –
The Pharmaceutical
Compliance Congress
Compliance
Monitoring
Congress
The International
Pharmaceutical
Compliance Congress
Transparency
and Aggregate
Spend East

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DAY ONE
Tuesday, 21 October 2014
7:15 Main Conference Registration and
Continental Breakfast
8:20 Chairman’s Welcome and Opening Remarks
Joe Kent, BSC (HONS), MBA,
Chief Compliance Officer – Europe & Canada,
Takeda Pharmaceuticals International GmbH
8:35 INDUSTRY PANEL
Compliance as a Means to Success —
Best Practices to Promote Cohesive
Global Compliance Practices
• Hear diverse examples of how to enhance compliance
internally across all offices
* foster trust and understanding of the
importance of compliance across all business
sectors and departments
• Review challenges associated with creating a culture of
compliance that adapts to a changing marketplace and
adjustment in codes and regulations
• Analyse how to improve communication between
business and compliance
• Assess strategies to improve internal controls to instill
values throughout an organisation
Moderator: Jeffrey Rosenbaum, Vice President, Chief Compliance Officer,
Vertex
Panelists: Edoardo Lazzarini, Ph.D., European Compliance Officer, Vice President,
Biomet Europe
Garineh Dovletian, Senior Vice President, Chief Risk Officer,
The Medicines Company
Kelly Hawson, UK Compliance Officer, Mundipharma
Sigrid Williame, Vice President, Compliance Officer,
GlaxoSmithKline Vaccines (Invited)
L. Kathleen Durousseau, Esq., Ethics and Compliance Officer,
Established Products, Abbott Products Operations AG
9:35 ETHICS KEYNOTE
Compliance Is OK, Applied Ethics Is Better
• Realise the importance of focusing on ethical attitudes
accross a global company and the total workforce
• Ascertain the reason for equal focus on ethics and
compliance within an organisation on a global level
• Discuss why an ethical employee base is essential in
every organisation doing business internationally
• Examine the results of lack of ethics within an
organisation and possible negative outcomes
Leo Neels, Ph.D., Chairman of the Advisory Board, Healthcare
Management Institute, Vlerick Business School;
Former CEO, pharma.be; Former Member of Ex Com, EFPIA;
Former Board Member, IFPMA
10:15 Networking and Refreshment Break
10:45 ENFORCEMENT KEYNOTE
Healthcare Enforcement —
Regional and National Law Updates,
Trends and Top Priorities
• Discuss findings regarding health insurance,
both public and private in terms of fraud,
abuse and waste
• Understand the role of government and
NHS in tackling corruption involving marketing,
procurement and bribery
• Analyse current findings and assess report
results surrounding enforcement initiatives
and recommendations
• Review response and mitigation activities of
pharmaceutical manufacturers to identify areas
of improvement
• Assess the difference between fraud and abuse
Paul Vincke, Managing Director,
European Healthcare Fraud and Corruption Network
Holger Diener, Managing Director, Association of Voluntary
Self-Regulation for the Pharmaceutical Industry
11:30 LEGAL ROUNDTABLE KEYNOTE
Patent Settlements and Anti-Competitive
Agreements — Impact on Compliance
and Legal
The number of patent settlements involving
pharmaceutical manufacturers has continued to rise
for six consecutive years. However, the type and scope
of these settlement agreements change year over year.
Therefore, it is crucial for legal and compliance teams to
understand the intricacies involved in these agreements
to better streamline existing compliance controls.
• Review recent patent settlements and anti-trust
law violations
• Understand the intersection between different
regulations and potential risk associated with patents
and innovation
• Assess emerging issues — General innovation and
corporate agreements
Ulf Grundmann, Parner, King & Spalding
Marcus Glader, Partner, Vinge
12:15 Networking Luncheon

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13:30 C H O O S E F R O M T H R E E B R E A K O U T S
BREAKOUT A
Cross-Border Activities
and HCP Interactions —
Local vs. Global Issues
Due to differing and often changing
laws, as well as a greater need for
transparency, increased oversight is
needed to ensure compliance over
HCP interactions, especially across
country lines. In this breakout, benefit
from diverse industry experiences and
learn how to mitigate risks associated
with tracking and managing HCP
interactions internationally.
• Understand the risks associated
with sponsorship of HCPs to attend
educational and speaker programmes
• Overcome challenges when engaging
HCPs in speaker programmes, symposia
and advisory boards across borders
• Discuss potential FCPA and FMV issues
caused by cross-border activities
Marc Christian Bauer, Director, Senior Legal Counsel,
Amgen International Law Group
Poul Madsen, Nordic Compliance Officer,
EUCAN Compliance, Takeda Pharma A/S
Michael Bartke, Ph.D., Director Compliance Management,
Daiichi Sankyo Europe GmbH
BREAKOUT B
Effective Third-Party
Intermediary Anti-Bribery
and Anti-Corruption
Programme Management
As supply chains continue to become more
complex, it is crucial for internal teams to
ensure proper monitoring and auditing
of third-party activities, especially in new
regions or with new partners. As more
and more responsibilities are outsourced,
such as sales, marketing and distribution,
it is the responsibility of the manufacturer
to manage external partners and identify
areas of possible concern. This session
reviews compliance risks by country, as
well as best practices to conduct thorough
anti-corruption programmes.
• Customise compliance programmes
to appropriately allocate resources to
high- risk areas
• Revise business processes based upon
anti-corruption and third-party oversight
compliance practices
• Train employees and third parties to assess
and prevent common ABAC concerns
• Conduct thorough investigations
according to standardised best practices
Tamara Tubin, Director, Corporate Compliance,
Biogen Idec International GmbH
Invitation-Only
CCO Summit
12:15 Lunch
13:30 Summit Host Welcome and
Anti-Trust Guideline Reminders
This Summit is designed to encourage
an open exchange of ideas and
strategies surrounding some of the most
critical issues facing Chief Compliance
Officers across the life sciences industry.
Facilitators lead discussions surrounding
key questions, challenges and issues
facing CCOs today. Participants benefit
from exclusive networking with peers
in similar positions, share challenges
and pose questions of their colleagues
to come away with valuable insight into
current and future compliance initiatives.
An antitrust attorney is present
throughout the Summit to ensure
appropriate and compliant discussion
among participants.
*Invited participants hold the title of Chief
Compliance Officer, Vice President of Compliance,
General Counsel or an equivalent compliance
leadership position at a life sciences company
(at the time of the conference). Final eligibility
approval is at the discretion of CBI.
15:00 Networking and Refreshment Break
15:30 C H O O S E F R O M T H R E E B R E A K O U T S
BREAKOUT C
Compliance Challenges
for Small to Mid-Size
Pharmaceutical Companies
During this unique and collaborative
breakout featuring insights from
compliance experts from small to
mid-size companies, attendees have the
opportunity to contribute to conversation
related to compliance challenges specific
to their needs, resources and bandwidth.
• Analyse specific challenges to adherence
with local anti-bribery regulations
• Assess the organisational structures of
compliance programmes
• Discuss the impact of regional and
national law updates
• Review the compliance challenges
associated with R&D innovation and
trial processes
Peter Herrmann, Corporate Compliance Officer,
Actelion
Timothy S. Ayers, Vice President, Porzio Life Sciences;
Principal, Porzio, Bromberg & Newman
Robert McKague, Senior Vice President,
Chief Compliance Officer, Jazz Pharmaceuticals
BREAKOUT D
Strategies to Implement
Cross-Border Compliance,
Transparency and
Regulatory Specifications
• Evaluate and review the complete
pre-approval process and transparency
of HCP/HCO payments
• Receive a thorough overview of
end-to-end disclosure process for
transfers of value
• Manage interactions between
European, USA and Asia Pacific (AP) rules
of disclosure within the same process
• Benefit from real world examples of
EFPIA code implementations within
over 30 countries
Francis Geysermans, Chief Technology Officer (CTO),
BMI SYSTEM
Laurent Clerc, Regulatory Affairs Expert,
BMI SYSTEM
Invitation-Only
CCO Summit (Cont’d)
Topics for Discussion:
I. FCPA and Due Diligence
II. Transparency of HCP Data
III. Role of CCO in HCP Cross
Border Relationships
IV. Risk Assessments,
Auditing and Monitoring
V. Data Privacy
Summit Leaders:
Marc-Olivier Lamaro, Chief Compliance Officer,
Sanofi Pasteur MSD
Kersten Schmahl, Vice President,
Ethics and Compliance – Europe and MEAPP, Actavis
Sigrid Williame, Vice President, Compliance Officer,
GlaxoSmithKline Vaccines
17:00 Close of Day One
NETWORKING WINE AND CHEESE COMMENCES AT THE CLOSE OF DAY ONE

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DAY TWO
Wednesday, 22 October 2014
7:00 Main Conference Registration and
Continental Breakfast
8:10 Chairman’s Welcome and Opening Remarks
Joe Kent, BSc(HONS), MBA,
Chief Compliance Officer – Europe & Canada,
Takeda Pharmaceuticals International GmbH
8:20 EFPIA KEYNOTE
Analyse Best Practices to Maintain and Uphold
EFPIA Code Leading up to 2015 Reporting
• Review expectations placed on the industry by EFPIA
for global transparency
• Streamline processes to adhere to global regulations in
addition to EFPIA code
• Analyse how to prepare organisationally to
begin reporting
• Understand the subtle difference between countries in
regards to reporting
Richard Bergström, Director General, EFPIA (European Federation of
Pharmaceutical Industries and Associations)
9:00 KEYNOTE PANEL
Global Transparency of HCP Data —
The Current Environment and Future
Direction of Disclosure Code
• Analyse how different countries are approaching
HCP spend reporting
• Obtain guidance based on important components of
local requirements
• Identify key tactics for your company to embrace new
code provisions and updates
• Gain varying regional and local insights into
transparency of HCP data
Moderator:
John Patrick Oroho, Executive Vice President and Chief Strategy Officer,
Porzio Life Sciences; Principal, Porzio, Bromberg & Newman
Panelists:
Michael Bartke, Director Compliance Management,
Daiichi Sankyo Europe GmbH
Leo Neels, Ph.D., Chairman of the Advisory Board, Healthcare
Management Institute, Vlerick Business School; Former CEO,
pharma.be; Former Member of Ex Com, EFPIA; Board Member, IFPMA
Richard Bergström, Director General, EFPIA (European Federation of
Pharmaceutical Industries and Associations)
9:40 Networking and Refreshment Break
10:10 C H O O S E F R O M T H R E E C O M P R E H E N S I V E T O P I C I N T E N S I V E S ( 1 - 3 )
TOPIC 1
Advanced Compliance
Issues in Commercial
Activities
10:10 Topic Intensive Chair’s
Opening Remarks
Kevin Espinoza, Vice President,
Ethics and Compliance Officer,
BTG International Inc.
10:15 Align Internal Teams
Through a Centralised
Compliance Language
• Develop a compliance
programme that adheres to
UK Anti-Bribery and FCPA
without excluding local laws
• Strategise how to effectively
monitor HCP data to
decrease risk
• Benefit from a case study
surrounding a due diligence
programme that united
compliance teams globally
to mitigate anti-kickback and
corruption risks
Kelly Hawson,
UK Compliance Officer,
Mundipharma
TOPIC 2
Global Auditing and
Monitoring — Data Analysis
and Risk Assessment
10:10 Topic Intensive Chair’s
Opening Remarks
10:15 Compliance Programme
in BI Italy — Re-Thinking
Compliance as a Way to
Ensure Business Continuity
and Sustainability
• Assess challenges associated with
bribery and anti-corruption risk
assessments in Italy
• Address ways to identify risk
throughout a specific governance
and organisation model
• Monitoring and auditing specific
approaches for different compliance
matters in order to improve
awareness and commitment to
compliance programmes
• Understand the cost of
non-compliance, both financially
and in terms of reputation
Giuseppe Palmieri, Head of Risk and
Compliance Management and Audit,
Chairman of Supervisory Body,
Boehringer Ingelheim
TOPIC 3
Global Anti-Bribery
and Corruption
Compliance
10:10 Topic Intensive Chair’s
Opening Remarks
Jeff Rosenbaum, Vice President,
Chief Compliance Officer, Vertex
10:15 Controls and Mitigation
Plans for Clinical
Trial FCPA and
Anti-Bribery Risks
• Assess emerging risks
associated with local and
global clinical trials
• Gain insight from a CRO in
terms of how to apply best
practices for risk mitigation
plans in clinical trials
• Understand transparency
requirements surrounding
clinical trials
• Analyse anti-kickback risks in
clinical trials
Case
Study
Case
Study

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11:00 The Evolving Role of
the Medical Science
Liaison (MSL)
• Discuss emerging risks
and uncertainties
surrounding MSLs
• Understand the realities
and misperceptions as
seen by medical and
commercial teams
• Discuss role enhancements
that mitigate risk and increase
value to the organisation
• Identify useful measures of
effectiveness and performance
of MSL teams
Kevin Espinoza, Vice President,
Ethics and Compliance Officer,
BTG International Inc.
11:00 Strategies to Build an
Effective Risk-Based
Compliance Monitoring
Programme
• Identify the areas of highest risk
to isolate areas of importance
to address
* disseminate proper information
to employees based upon
high risk areas in their regions
• Understand who the
stakeholders are throughout
the risk assessment process
• Determine how to assess the
impact of risk-based compliance
processes on financial,
reputational or business
• Pinpoint challenges associated
with cultural perceptions
of corruption
Nicolai Ellehuus, Head of Legal and Compliance,
Nordics, Mundipharma
11:00 Establish an Effective
Anti-Corruption
Programme to
Mitigate Risk
• Create an operational structure
that effectively values and
manages risks
• Gain insight on processes to
enhance oversight on areas
of high concern and
understand the scope of
local anti-corruption laws
• Work with in-country
leadership to ensure internal
development of compliance
programmes to review policies
and procedures
Andriy Kirmach, Compliance and Ethics
Manager, EAME and CIS Direct Markets,
Allergan Holdings Limited
11:40 Networking Luncheon
1 3 : 2 0 C H O O S E F R O M T H R E E C O M P R E H E N S I V E T O P I C I N T E N S I V E S ( 4 - 6 )
TOPIC 4
Global Transparency
and Reporting of
HCP Payments
13:20 Topic Intensive Chair’s
Opening Remarks
John Patrick Oroho, Executive Vice President
and Chief Strategy Officer,
Porzio Life Sciences; Principal,
Porzio, Bromberg & Newman
13:25 Improve Systems to
Enhance Aggregate
Spend, Disclosure and
Transparency Processes
and Implementation
• Review the expectations
placed on the industry by
EFPIA for global transparency
• Assess how to streamline
processes to adhere to
global regulations in addition
to EFPIA code
• Analyse how to prepare
organisationally to evolve
systems to your needs to
improve reporting
• Implement a system that is
right for your organisation
David Eves,
Director of Medical Affairs & Compliance,
Chugai Pharma UK
TOPIC 5
Compliance Programme
Structure and
Operational Excellence
13:20 Topic Intensive Chair’s
Opening Remarks
Garineh Dovletian,
Senior Vice President, Chief Risk Officer,
The Medicines Company
13:25 Emerging Compliance
Risks and the Impact on
Compliance Team Structure
• Assess what a compliance
programme should look like in
light of increased government
funding and contracting
• Understand the impact of rising
costs and emergence of generics
• Discuss the relationship
between compliance and
legal to improve efficiencies
• Analyse the shift of commercial
and R&D processes from local
to multi-national programmes
• Ensure proper dissemination
of compliance protocols to all
new employees
Garineh Dovletian,
Senior Vice President, Chief Risk Officer,
The Medicines Company
TOPIC 6
Emerging Nations —
Trends and Risk Analysis
13:20 Topic Intensive Chair’s
Opening Remarks
Brian Beeler, Chief Compliance Officer,
Horizon Pharma
13:25 Cultural Considerations
and Current Challenges
in Emerging Markets
• Understand the challenges of
working with certain cultures
to effectively create an
environment for anti-bribery
and FCPA enforcement
• Discuss obstacles for
mitigating and monitoring
risks in emerging nations
• Assess cultural norms
and mentalities to
prevent corruption
Eileen Radford,
Director of Advisory Services,
TRACE
12:40 FDA KEYNOTE
The Role of the FDA in Global
Inspections and Investigations
• Why is the FDA devoting a team
to advance a mutual reliance
agreement with the EU?
• How can the US and EU overcome
the obstacles to sharing public
health information contained
in inspection reports?
• Are there different standards and
approaches to enforcement in the
US and EU?
Dara Corrigan, Associate Commissioner,
Regulatory Affairs, Director, Europe Office, FDA

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14:05 Put it All Together — Implement
a Truly Global HCP/O Contracting
and Transparency Solution
• Discuss the impact of EFPIA
Transparency Guidance going live
in 2015
• Review the need for true global
HCP compliance solutions due to
US Sunshine, global transparency
requirements and EFPIA Guidance
• Explore the process, technology and
implementation challenges
• Analyze the impact on change
management, cross-border
transactions, HCP contracting,
FMV and enrichment data
Marc Eigner, Partner,
Polaris Manaement
14:45 Transparency Initiative vs.
Personal Data Protection
Law — Key Challenges for Russia
• Address challenges associated with
collecting HCP data for different regions
• Analyse considerations
for regional vs. global,
culture and currency
• Describe legal framework for
transparency initiative in Russia
• Present Association of International
Pharmaceutical Manufacturers (AIPM)
role in support of
transparency initiative
• Discuss best practices to streamline
transparency implementation
Alexey Kolotvin, Compliance Manager,
Takeda – Russia
14:05 Establish Effective
Multi-National
Compliance Programmes
— Standardise Processes
across Local and Global
Offices
• Discuss the challenges
of diverse cultures on
compliance organisations
and structures
• Find the point of contact
between requirements of
global programme and actual
implementation in
the country
• Encourage proper oversight
and audit participation both
locally and globally
• Assess challenges for local
offices in establishing
processes away from the
global headquarters
• Analyse the potential risks
associated with building
multi-national programmes
Edoardo Lazzarini, Ph.D., European
Compliance Officer, Vice President,
Biomet Europe
14:05 Third-Party Oversight
and Due Diligence —
Strategies to Identify
High Risk Areas
• Identify possible embargos
and high risk areas
through thorough
third-party investigations
• Assess the importance
of third-party audits across
the supply chain
• Analyse the heightened
risks associated with
emerging markets
Brian Beeler,
Chief Compliance Officer,
Horizon Pharma
15:15 Close of Congress
About Our CCO Summit Host:
Porzio Life Sciences, LLC (PorzioLS) provides the life science industry with Internet-based products
enabling companies to comply with marketing and sales federal and state laws and regulations,
as well as, distribution licensing, sampling and a growing body of state life science compliance
requirements. PorzioLS provides compliance tools and customized services, related to the PDMA,
anti-kickback statutes, aggregate spend reporting, OIG and CMS guidances, OPDP promotional
violations, False Claims Act and FDA regulations, such as the Porzio Compliance Digest and Porzio
AggregateSpendID, a best in class aggregate spend system capable of handling state and federal
transparency reporting and dispute resolutions, in addition to sample transparency reporting.
Porzio AggregateSpendID streamlines state and federal marketing disclosures by automating the collection and accurate
reporting of expenses directed to healthcare practitioners and organizations. The searchable databases of the Porzio
Compliance Digest cover drug and device distribution licensing, transparency legislation, sample and trade product distribution,
and trends in government investigations.
Through our Distribution Licensing Services, we identify and attain all required licenses based on a
company’s unique distribution model. Finally, our formula-based approach to sample accountability,
Significant Loss Threshold Assurance, ensures that customers neither over or under report sample
losses. These compliance tools and customized services facilitate companies’ compliance with
federal and state marketing and sales regulations, which has propelled PorzioLS into an industry
leader in life science marketing and sales compliance.
The International Life Sciences Transparency Database provides guidance on non-US disclosure
requirements pertaining to interactions with HCPs and HCOs and provides easy-to-read excerpts
and summaries (in English) on crucial global information including, non-US reporting requirements
concerning HCP/HCO transfers of value, anti-bribery and anti-corruption, prohibitions and financial
limitations on HCP/HCO interactions and data privacy. The International Database also contains
EFPIA, Eucomed, IFPMA and Mecomed international industry and member association codes.
Strengthen your compliance program today by visiting www.porziolifesciences.com or contacting us 877-477-7411.

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21-22 October 2014 • Renaissance Brussels Hotel • Brussels, Belgium
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internationalcompliance
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ANY QUESTIONS OR TO REGISTER
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International Pharmaceutical Compliance Congress PC14084
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Your registration may be transferred to a member of your organisation up to 24 hours in advance of the
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the registration fee less the €221 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
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Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation,
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REGISTER AT WWW.CBINET.COM/INTERNATIONALCOMPLIANCE • +1-339-298-2100