21-22 October 2014 • Renaissance Brussels Hotel • Brussels, Belgium

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

The Most Comprehensive and Strategic Event Dedicated to Managing and Enhancing Your Global Compliance Programmes:

Michael Bartke, Ph.D., Director Compliance Management, Daiichi Sankyo Europe GmbH

Featured Faculty Members Include:

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:

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 A V E € 4 0 0 !

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CCO Summit Host:

Marc Christian Bauer, Director, Senior Legal Counsel/Rechtsanwalt, Amgen International Law Group

Michael Bartke, Ph.D., Director Compliance

Management, Daiichi Sankyo Europe GmbH

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

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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.

CONFERENCE SPONSORS

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

Global Transparency Reporting Congress

WE’VE GOT COMPLIANCE DOWN TO A (GLOBAL) SCIENCE...

Transparency and Aggregate Spend East

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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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

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 IssuesDue 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 BEffective Third-Party Intermediary Anti-Bribery and Anti-Corruption Programme ManagementAs 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 Summit12:15 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

BREAKOUT CCompliance Challenges for Small to Mid-Size Pharmaceutical CompaniesDuring 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, ActelionTimothy S. Ayers, Vice President, Porzio Life Sciences; Principal, Porzio, Bromberg & Newman

Robert McKague, Senior Vice President, Chief Compliance Officer, Jazz Pharmaceuticals

BREAKOUT DStrategies 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 SYSTEMLaurent 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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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 )

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 GmbHLeo 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, IFPMARichard Bergström, Director General, EFPIA (European Federation of Pharmaceutical Industries and Associations)

9:40 Networking and Refreshment Break

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 RemarksJeff 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

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Case Study

Case Study

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 )

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

TOPIC 4

Global Transparency and Reporting of HCP Payments 13:20 Topic Intensive Chair’s

Opening RemarksJohn 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 RemarksGarineh 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 RemarksBrian 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

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12:40 FDA KEYNOTEThe 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

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

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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.

SCAN HERE

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International Pharmaceutical Compliance Congress PC14084

VENUE: Renaissance Brussels Hotel Rue du Parnasse 19 1050 Brussels, Belgium Toll free: 32-0800-18-222 Hotel direct line: 32-2-505-2500

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Book Now! The Renaissance Brussels Hotel 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: REGISTER BY 1 AUGUST 2014

REGISTER BY 7 SEPTEMBER 2014

REGISTER BY 21 OCTOBER 2014

2-Day Conference €1399 + 21% VAT €1599 + 21% VAT €1799 + 21% VAT

Register by 12 September 2014 and SAVE €400. 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 final, Standard Rate.

TEAM DISCOUNT: Attend this conference FREE if you bring 3 registered colleagues from your organisation or external to your organisation (enables cross-company teams). All team registrations must be made at the same time to qualify. Please contact +1-339-298-2100 for further information.

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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 €221 administrative charge. No refunds will be made after this date; however, 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 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.

21-22 October 2014 • Renaissance Brussels Hotel • Brussels, Belgium

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