THE INDUSTRY’S PREMIER EVENT FOR STRATEGIES TO OPTIMIZE TRANSPARENCY REPORTING ACROSS GLOBAL

9TH

AGGREGATE SPEND AND OPEN PAYMENTS CONFERENCE

CHAIRPERSON

ISHITA ARORA Compliance Manager, HORIZON PHARMA PLC

ELIAS SHAMIYEH Global Head of Project Management Transparency, SANOFI

AMIE PHILLIPS PABLO Associate Director, Government Reporting, NOVO NORDISK

MICHAEL O’CONNOR Former Senior Director, Global Head Compliance and Ethics Operations, ALEXION PHARMACEUTICALS,

DEREK DEVGUN Legal Director, Restorative Therapies Group, MEDTRONIC

ANN N. JAMES, PH.D. , J.D. RMG Senior Compliance Contract Manager, OFFICE OF GENERAL COUNSEL, STANFORD UNIVERSITY

FRANK ORLOWSKI Senior Director, Finance Leader Emerging Markets and Transition Sites (Retired),PFIZER

June 11–12, 2018 | Sonesta Philadelphia, Hotel Rittenhouse Square, Philadelphia PA

LEARNING OBJECTIVES

Uncover ways to optimize your organization’s aggregate data

reporting processes

Avoid violations within high-risk areas by optimizing

internal monitoring

Drive compliance with tangible data analytics and

management processes

Harmonize compliance operations with new business

systems and evolving promotional activities

Use transparency data in innovative ways to support

cross-functional teams

SPONSORS

Interested in discussing your organization’s solutions and services with potential clients attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Chris Summa, Business Development Manager, at (917) 932-0432 or csumma@exlevents.com.

DO YOU WANT TO SPREAD THE WORD ABOUT

YOUR ORGANIZATION’S SOLUTIONS?

Dear Colleague,

Transparency reporting is an integral part of the life sciences industry. Aggregating reporting of compensation data is a complex process; the moving pieces involved require precise attention to avoid conflicts of interest that appear to blur the line between promotional activities and proper conduct of medical research, training, and practice. Fortunately, regulations put in place by the Physician Payments Sunshine Act have functioned a transparency platform for all payments across the industry.

Compliance leaders attempt to reduce discrepancies before the reporting deadline, but continually spend millions of dollars every year to manage reporting errors. In this highly regulated environment, industry leaders must come together and discuss strategies to minimize errors and optimize current processes.Tracking aggregate spend and maintaining transparency requires a companywide effort to keep organized, compliant, and ready for submission. 9th Aggregate Spend and Open Payments Conference is the industry’s premier event for strategies to optimize transparency reporting for compliance programs. This event will bring together professionals from across the compliance landscape to discuss past submissions and upcoming changes in order to better prepare their company’s system.

WHO SHOULD ATTEND This conference is designed for representatives from pharmaceutical, biotechnology, and medical device companies and advocacy groups with responsibilities in the following areas:

( Aggregate Spend

( Compliance

( Transparency

( Corporate/Regulatory/Risk Compliance and Ethics

( Government/Federal/State Reporting

( Transparency Spend Reporting

( Legal and Regulatory Affairs

( Business Analysis and Development

( Finance and Accounting

( Financial Management Analytics

( Data Management

( Professional Affairs

( Sales and Marketing

( Commercial Operations

( Clinical Operations/Disclosure

( Medical Affairs

( Contract Administrators

( Grant Writing

( Internal and External Training

( Engagement

This conference is also of interest to:

( Sunshine Reporting Solution Providers

( Data Management Solution Providers

( Complaisance Solution Providers

( Transparency Reporting Solution Providers

9TH

AGGREGATE SPEND AND OPEN PAYMENTS CONFERENCE

8:00 Registration Opens and Continental Breakfast

9:00 Opening Remarks

Frank Orlowski, Senior Director, Finance Leader Emerging Markets and Transition Sites (Retired), PFIZER

9:15 Manage Risks Through Metrics and Data Aggregation ( Improve processes and systems for collecting complete and accurate

data ( Ensure the correct HCP is associated with the proper spend ( Build a framework for data remediation that can be tailored across

departments ( Optimize methods to identify data outliers and areas of incompleteness

more quicklyMichael O’Connor, Former Senior Director, Global Head Compliance and Ethics Operations, ALEXION PHARMACEUTICALS

10:00 Develop Innovative Strategies to Capture Complete and Accurate HCP Spend

( Highlight key considerations when looking for an automated spend management solution that supports global transparency regulations

( Assess the value of centralizing expense and invoice HCP spend in one solution

( Innovate procedures for tracking HCP spend and complying with the different global transparency regulations

( Discuss what automated spend management solutions save in terms of resources — efficiencies and data integrity

Michael Pace, Director of Life Sciences, CONCUR

10:45 NetworkingBreak

11:15 Optimize Your Aggregate Spend Data to Enhance Compliance Analytics

( Strengthen communication and the management of data across departments

( Explore methods for leveraging your risk assessment when building analytics dashboards

( Define best practices for efficient and effective transparency reporting Ishita Arora, Compliance Manager, HORIZON PHARMA PLC

12:00 Use Data Analytics to Drive Compliance ( Hold data sources accountable for completeness and proper submission ( Work closely with risk evaluation teams to ensure the collection of quality

data ( Define roles and objectives of internal teams to avoid submission errors

and optimize reportingAmie Phillips Pablo, Associate Director, Government Reporting, NOVO NORDISK

12:45 NetworkingLuncheon

1:45 LeverageTransparencyDatatoEnsureComplianceinHigh-RiskAreas

( Implement a cloud-based aggregate spend platform to improve auditing/benchmarking capabilities

( Consider the impact of built-in analytics for real time monitoring & risk detection

( Build sustainable analytic programs that can be digested and utilized by other areas within the company

Panelists: Charlene E. Davis, Esq., Healthcare Compliance North America, SUN PHARMACEUTICAL INDUSTRIES, INC

Natalia Morozkina, Compliance Manager, OTSUKA PHARMACEUTICAL COMPANIES

Michael O’Connor, Former Senior Director, Global Head Compliance and Ethics Operations, ALEXION PHARMACEUTICALS, INC.

Ishita Arora, Compliance Manager, HORIZON PHARMA PLC

2:45 NetworkingBreak

3:30 Meet Business Goals and Maintain Compliancy With InterdepartmentalCollaborations 

( Harmonize compliance strategies with new business system and evolving promotional activities 

( Mitigate risks and avoid potential rework by partnering with compliance leadership present during strategic planning meetings

Richard Eschle, Executive Director, Corporate Ethics and Compliance, EISAI INC.

4:15 EnsureSpeakerProgramCompliancyThroughCross-FunctionalTeams

( Collaborate with compliance teams to develop data collection protocols that ensure transparency data is aggregated fully and properly

( Discuss how cross-functional teams can prep speaker programs for an audit

( Consider technologies that improve the ease of aggregate data without sacrificing the speaker program content

Jenny Shire, Associate Director, Professional Programs, DAIICHI SANKYO

4:45 ChairpersonClosingRemarks

Frank Orlowski, Senior Director, Finance Leader Emerging Markets and Transition Sites (Retired), PFIZER

5:00 Day One Concludes

AGENDA DAY ONE | MONDAY, JUNE 11, 2018

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8:00 Continental Breakfast

9:00 Chairperson Recap of Day One

Frank Orlowski, Senior Director, Finance Leader Emerging Markets and Transition Sites (Retired), PFIZER

9:15 DiscoverCreative,FullyFCPA-CompliantMethodstoBuildPartnerships With Governments, Hospitals, and Key Decision Makers in Emerging Markets

( Hear best practices to maintain anti-corruption and compliance from a large company perspective, when entering developing markets including participation in case study workshops

( Learn firsthand how to implement training programs for all levels of the organization to ensure that collaboration with government and customs agencies are held to FCA Standards

( Understand how to develop in-country reporting mechanisms and other compliance validation practices to affirm compliance and controls policies are adhered to in each global market

Frank Orlowski, Senior Director, Finance Leader Emerging Markets and Transition Sites (Retired), PFIZER

10:00 Key Considerations for Managing Mergers and Acquisitions for Transparency Reporting

( Discuss compliance program integration strategy with change management considerations

( Develop remediation steps, if necessary, to credibly fill any gaps or strengthen any weaknesses post-acquisition

( Consider the overlap between system optimization and handling areas of integrations

Derek Devgun, Legal Director, Restorative Therapies Group, MEDTRONIC

10:45 NetworkingBreak

11:15 Risk Assessment Strategies to Achieve Global Business Goals WhileAvoidingRisks 

( Develop reporting mechanisms and other compliance validation practices to ensure compliance across global partnerships

( Discuss trends in global compliance regulations with a focus on drug communication restrictions and reimbursement considerations 

( Compare U.S. compliance policies to those across the global compliance landscape

Department of Corporate Ethics and Compliance, EISAI INC.

12:00 PrioritizingRisksandAvoidingViolationsWithinHigh-RiskAreas

( Identify strategies to avoid violations in high-risk areas like speaker programs

( Tracking allocated funds to ensure payment was delivered to the reported party

( Best practices for eliminating human error from aggregate spend data in high-risk programs

( Update systems to optimize submission operations and handle areas of integrations

Avi Spira, Chief Compliance, Risk and Privacy Officer, FUJIFILM HOLDINGS AMERICA CORPORATION

12:45 NetworkingLuncheon

1:45 UnderstandtheImpactofNewStateRegulationsonReportingProcesses

( Discuss strategies to implement internal reporting processes to give varied state requirements

( Consider the state aggregate spend requirement that are not be preempted by the Federal Sunshine Act

( Optimize strategies to drive compliance given a larger set of reportable activities by some states

( Examine recent federal- and state-level trends in enforcement targets ( Understand cross-departmental impact of reported data on both a federal

and state levelAnn N. James, Ph.D., J.D., RMG Senior Compliance Contract Manager, OFFICE OF GENERAL COUNSEL, STANFORD UNIVERSITY

2:30 Compliant Collaborations With Healthcare Professionals Across Global Transparency Landscapes

( Promote productive and transparent relationships between your organization and HCPs

( Understand global regulatory authorization strategies and how to best utilize regulatory mapping

( Build productive transparent relationships given engagement restrictions in emerging markets

( Utilize digital platforms as a healthy method of engagement Elias Shamiyeh, Global Head of Project Management Transparency, SANOFILinda Sarnecki, Director, Business Partner Transparency and Compliance, SANOFIEkaterina S. WallØe, R&D Business Ethics Compliance Specialist, NOVO NORDISK

3:30 Chairperson Closing Remarks

Frank Orlowski, Senior Director, Finance Leader Emerging

AGENDA DAY TWO | TUESDAY, JUNE 12, 2018

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Sonesta Philadelphia Hotel Rittenhouse Square1800 Market St. Philadelphia, PA 19103

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Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

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9TH

AGGREGATE SPEND AND OPEN PAYMENTS CONFERENCE

CHAIRPERSON

ISHITA ARORA HORIZON PHARMA PLC

ELIAS SHAMIYEH SANOFI

AMIE PHILLIPS PABLO NOVO NORDISK

MICHAEL O’CONNOR ALEXION PHARMACEUTICALS, INC.

DEREK DEVGUN MEDTRONIC

ANN N. JAMES, PH.D. , J.D. OFFICE OF GENERAL COUNSEL, STANFORD UNIVERSITY

FRANK ORLOWSKI PFIZER INCORPORATED

THE INDUSTRY’S PREMIER EVENT FOR STRATEGIES TO OPTIMIZE TRANSPARENCY REPORTING ACROSS GLOBAL

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June 11–12, 2018 | Sonesta Philadelphia, Hotel Rittenhouse Square, Philadelphia PA

Please make checks payable to: “PMA"