3rd Reporting Aggregate Spend & Sunshine Act Compliance Conference

1. Presents
The 3rd Reporting Aggregate
Spend & Sunshine Act
Compliance Conference
Strategies for Data Collection and Disclosure that Comply with Federal
and State Requirements in an Era of Health Care Reform
June 7-8, 2012 • Hyatt at The Bellevue • Philadelphia, PA
Join us and share best Featured Sessions:
practices with these
organizations: ANALYZE THE NEW REGULATIONS RELEASED
IN THE SUNSHINE ACT
Luanna Saulino, Associate Director, Disclosure Law & Transparency Operation,
ACTELION BAYER PHARMACEUTICALS
LEARN BEST PRACTICES IN DATA TRACKING,
BAYER
COLLECTION, AND INTERNAL AUDITING
BIOGEN IDEC Bill Friedrich, Director of State Reporting / TIG, External Medical Communications,
PFIZER
CENTOCOR UNDERSTAND THE CHALLENGES PHYSICIANS FACE AS
A RESULT OF THE ADDITIONAL EXPOSURE
JANSSEN
Michael Varlotta, Senior Director Medical Education,
JANSSEN SERVICES
JOHNSON & JOHNSON
ADDRESS THE ISSUE OF WHO, WHAT, WHERE, WHEN
PFIZER AND HOW TO REPORT AGGREGATE SPEND
Elizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, Global Operations,
PhRMA JOHNSON & JOHNSON
Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency, Metrics,
PROMETHEUS LABORATORIES & Reporting, JOHNSON & JOHNSON
SANOFI US
THE SPECTRANETICS CORPORATION
Plus! Regulatory Panel Discussion
Updates from MN, VT and MD on Expectations for
AND MORE… Reporting Requirements under the Sunshine Act
SPONSORS &
EXHIBITORS
TO REGISTER CALL 866-207-6528 OR VISIT WWW.EXLPHARMA.COM/AGGSPEND

2. The 3rd Reporting Aggregate This conference is designed for
representatives from pharmaceutical,
Spend & Sunshine Act biotechnology, and medical device
companies with responsibilities in the
Compliance Conference following areas:
• Corporate Compliance
DEAR COLLEAGUE: • Regulatory Compliance
• State Reporting
The Physician Payments Sunshine provisions in the healthcare reform legislation require drug
and medical device manufacturers to publicly report gifts and payments made to physicians • Business Analysis and
and hospitals. Companies must ensure that all data across various company departments Development
is accurately captured, collected, and reported. If companies fail to do so, they could face a
penalty with fines ranging anywhere from $150,000 to $1,000,000 per submission. With CMS
• Finance
just releasing the proposed regulations, and final regulations on the horizon, now is the time for • Regulatory Affairs
companies to prepare themselves for the Sunshine Act and the impact it is likely to have on their
company and clients.
• Government Affairs
• Ethics
ExL Pharma’s 3rd Reporting Aggregate Spend & Sunshine Act Compliance Conference • Sales & Marketing
is the perfect place to continue your preparation! This is the only national conference that offers • Commercial Operations
professionals from pharmaceutical, medical device, and biotechnology companies a complete
understanding of the requirements for aggregate spend reporting under the Sunshine Act. After • Clinical Operations
attending this conference, attendees are able to walk away with a better understanding of: • IT
• Medical Affairs
• Proposed Regulations • Industry-Physician Relationships
• Preemption • System Integration
• Data Management • Accurate Reporting
• Communication & Training • Ancillary Value Sponsorship and Exhibit
Opportunities
We look forward to greeting you in June for what is sure to be the most valuable event of its kind! Do you want to spread the word about
your organization’s solutions and services
to potential clients who attend this event?
Sincerely,
Take advantage of the opportunity to
exhibit, present an educational session,
host a networking event, or distribute
promotional items to attendees. ExL works
closely with you to customize a package
Kathryn Collins Matt Millman that suits all of your needs. To learn more
Conference Director Team Leader, Production about these opportunities, contact Mark
kcollins@exlpharma.com ExL Pharma Coulter, Senior Business Development
Manager, by calling 917-258-5140 or by
emailing mcoulter@exlpharma.com
HOTEL INFO
HYATT AT THE BELLEVUE, PHILADELPHIA
200 South Broad Street, Philadelphia, Pennsylvania, 19102 USA
Phone: 1(888) 421-1442
The city is yours to discover from Hyatt at The Bellevue. From the historic Liberty Bell and Independence Hall to the Museum of Art and
Eagles games at Lincoln Financial Field, you’ll find a wealth of attractions close to our Center City Philadelphia hotel.
If you require overnight accommodations, please contact the Hyatt at the Bellevue at 1-888-421-1442 to book your room. ExL has reserved
a block of rooms at a discounted rate for conference participants. Please mention “ExL June Meeting” to take advantage of the discount. You
must book your room by May 16, 2012 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate
are limited.

3. Day One – Thursday, June 7, 2012
8:00 Registration and Continental Breakfast Opens for Workshop Participants
PRE-CONFERENCE WORKSHOP
9:00 PRE-CONFERENCE WORKSHOP
Implementation Basics and Beyond: An Aggregate Spend Solution for Sunshine Act Compliance
• Living with Aggregate Spend: understanding the basics and making it manageable
• Evaluating reporting solutions to effectively identify what work will work for your company
• Identifying, classifying, and integrating spend sources, and adapting internal disparate systems
• What is an Aggregate Spend Master File? Why does it matter? How is it central to compliant and accurate reporting?
• Effective procedures and training to ensure consistency and continuity across the enterprise
• Reporting strategies for smaller companies
• Supplement: Summary of state and federal spend and disclosure requirements
Kim Life, Esq., Principal, LIFE COMPLIANCE SOLUTIONS
Dean Rossi, President, ALANDA SOFTWARE
*There will be a 30-minute networking and refreshment break during the workshop session
12:00 Luncheon for Workshop Attendees and Registration Opens for Main Conference
Main Conference Begins
3:30 Ensuring Spend is Accurately Accounted for Using
1:00 CHAIRPERSON’S WELCOME & OPENING REMARKS Data Tracking, Data Collection, and Internal Auditing
Katherine Cartwright Norris, Director, Corporate Compliance, Best Practices
THE SPECTRANETICS CORPORATION
• Understand the scale of your business
• Learn about the data format in your feeder system
1:15 OPENING PANEL DISCUSSION • Uncover your “data funnel” and how it needs to accept all data sources
How will the New Sunshine Act Regulations Affect Aggregate
Spend Reporting? Bill Friedrich, Director of State Reporting/TIG, External Medical Communications, PFIZER
Erik Hennings, Director, Compliance, AVANIR PHARMACEUTICALS
• Review the status of the recently released regulations
• Analysis of the necessary data that must be collected and reported
• Implementation strategies including integration of stake-holders 4:15 Managing Aggregate Spend Reporting Through
• Discuss the impact of the Sunshine Act as it relates to the future of Mergers and Acquisitions
pharmaceutical relationships with healthcare providers
• Analysis of Sunshine Act reporting requirements as it pertains to all parties
Moderator: involved in M&A
Yavuz Silay, MD, MBA, Vice President, Medical Affairs, IPSEN • Discussion of common questions — Who is required to report? Are reports filed
separately for different groups/teams/organizations?
Panelists: • Analysis of standing State guidelines that outline specific reporting requirements
Kendra A. Martello, Assistant General Counsel, PhRMA • Predictions for future reporting requirements based on pending legislation
Luanna Saulino, Associate Director, Disclosure Law & Transparency Operation, BAYER • Case studies: real-world examples of companies based in the U.S. but operated or
acquired by international companies, often with multiple subsidiaries — how is
Konstantinos Papandrikos, Director, Transparency Operations, US Medical Affairs, reporting handled?
SANOFI US
Eric Saharig, Project Manager, QPHARMA, INC.
2:15 Tracking and Disclosing Aggregate Spend 5:00 Current Impact of the Sunshine Act at the
Reporting 101: Addressing the Issue of Who, What, Global Level
Where, When and How to Report Aggregate Spend
• How Sunshine Act has been perceived in countries outside the US
• Train and communicate efforts around data integrity and aggregate spend • Discuss the other countries who have implemented similar transparency measures
• Address transaction management system needs and reporting requirements
• Understand and overcome the challenges around customer data Yavuz Silay, MD, MBA, Vice President, Medical Affairs, IPSEN
• Integrate business process improvements for effective data capture
Elizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, 5:45 Day One Concludes
Global Operations, JOHNSON & JOHNSON
Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency,
Metrics, & Reporting, JOHNSON & JOHNSON
3:00 Networking & Refreshment Break

4. Day Two – Friday, June 8, 2012
8:00 Continental Breakfast 11:15 Physician - Industry Relationships
8:50 CHAIRPERSON’S RECAP OF DAY ONE Internal Preparation and External Communication
with Physicians Facing Additional Exposure from
Katherine Cartwright Norris, Director, Corporate Compliance, the Sunshine Act
THE SPECTRANETICS CORPORATION
• Understanding the reaction and response to public payment information
• Preparing internal company personnel for how to respond to healthcare practitioner
9:00 REGULATOR PANEL DISCUSSION questions and concerns about disclosure
Updates from the Key States and Regulators on • Effectively communicating transparency initiatives to help raise awareness of
Expectations for Reporting Requirements Under forthcoming disclosure requirements
the Sunshine Act Michael Varlotta, Senior Director Medical Education,
• Examine what modifications have been made by each state as a result of the JANSSEN PHARMACEUTICALS
released regulations
• Hear from the states on their predictions of how regulations effect the industries
involved in 2013 and beyond
12:00 Implement Proactive Strategies to Manage
Physician Inquires Regarding Forthcoming
REGULATOR PERSPECTIVES
Reporting Transparency
Moderator:
Katherine Cartwright Norris, Director, Corporate Compliance, • Educate physicians effectively to ensure they receive accurate information about
THE SPECTRANETICS CORPORATION reporting regulations
• Successfully maintain industry-physician relationships through proper
Panelists:
communication efforts
MINNESOTA: Cody Wilberg, Pharm.D., M.S., R.Ph., Executive Director,
• Examples of best practices for preparation to the physician response
MINNESOTA BOARD OF PHARMACY
VERMONT: Kate Whelley McCabe, Assistant Attorney General, Public Protection Division, Konstantinos Papandrikos, Director, Transparency Operations, US Medical Affairs, SANOFI
VERMONT OFFICE OF THE ATTORNEY GENERAL
MARYLAND: Delegate Dan Morhaim, MD, Deputy Majority Leader, 12:45 Luncheon
MARYLAND HOUSE OF DELEGATES
1:45 The Health Care Transparency Ecosystem:
Understanding Physician Attitudes and Opinions
10:00 Managing Customer Expectations on Notification and Dispute Resolution
Developing the Right HCP Disclosure & Transparency • Review of CMS Proposed Rules as they relate to physician notification/dispute
Communication Plan for Your Organization resolution
Although the final requirements from CMS may be unknown at this time, we do know a • Review of AMA survey results on physician awareness and attitudes related to
significant number of physicians are still unaware of the disclosure requirements that may the notification/dispute resolution process
put their financial interactions with prescribed product manufacturers in the spotlight. • Overview of Case Study/Pilot Program
The impact of public disclosure on physician behavior and relationships with sales and • Sunshine Act Aggregate Spend Awareness: Educating physicians in this new
clinical is of growing concern to the industry. Many organizations have struggled with age of transparency
how to approach this communication problem, the message they want to deliver and how
to cost effectively and efficiently communicate a message of corporate responsibility. This Michaeline Daboul, President, MMIS, INC.
session focuses on the critical steps in developing a communication plan, key questions to
ask yourself as an organization, and various methods of communication that can be used 2:30 Assess the Ancillary Value of Aggregate Spend Data
to effectively deliver your message to healthcare professionals. as an Internal Business Wide Monitoring Tool
Wanda Toro Turini, PharmD, President, BULL’S EYE INNOVATIONS • Understand perception, identification, and management strategy
Developers of The Aggregate Spend RoadMap® • Evaluation of current business practices and associated expenditures
• Learn accurate compliance, auditing, and monitoring technique
• Benchmark corporate policies and procedures
10:45 Networking & Refreshment Break
Katherine Cartwright Norris, Director, Corporate Compliance,
THE SPECTRANETICS CORPORATION
3:15 Conference Concludes
“Good tactical information supported by helpful examples!”
– Senior Manager, Regulatory Compliance, PamLab Pharmaceuticals
“Thoughtful, articulate, and interesting commentary!”
– Corporate Compliance, Medtronic
“Excellent speakers providing relevant examples and tips!”
– Compliance Manager, Biotronik

5. Registration Fees for Attending ExL’s
The 3rd Reporting
Aggregate Spend
& Sunshine Act
Compliance
Conference
EARLY BIRD PRICING
Register by April 13, 2012
to Take Advantage of Early-Bird Pricing: Five Ways to Register
FAX: 888-221-6750
Conference + Workshop $1995
Conference Only $1695 MAIL: ExL Events, Inc.
555 8th Ave, Ste 310
STANDARD PRICING New York, NY 10018
Register after April 13, 2012
PHONE: 866-207-6528
Conference + Workshop $2195 EMAIL: registration@exlpharma.com
Conference Only $1895 ONLINE: www.exlpharma.com/aggspend
ONSITE PRICING
Media Partners
Conference + Workshop $2295
Conference Only $1995
GROUP DISCOUNT PROGRAM:
Save 25% Per Person when Registering
Four
For every three simultaneous registrations from your company, you will receive a
fourth complimentary registration to the program (must register 4 at one time).
This is a savings of 25% per person.
Save 15% Per Person when
Registering Three
Can only send three? You can still save 15% off of every registration.
To find out more on how you can take advantage of these group discounts,
please call 866-207-6528.
IMPORTANT! Offers may not be combined. Discount only applies to standard rate. Make checks
payable to ExL Events, Inc. and write code P1133 on your check. You may also use Visa, MasterCard,
Discover or American Express. Payments must be received in full, two weeks prior to the commencement Questions? Comments?
of the conference. Do you have a question or comments that you would like to be addressed at
Conference registrations may be transferred to other colleagues in the event you are unable to attend. this event? Would you like to get involved as a speaker or discussion leader?
Please notify ExL Pharma, info@exlpharma.com, prior to the event with the name and contact information
of the replacement attendee. There will be an administrative charge of $300 to substitute, exchange, and/ Please email Conference Director, Kathryn Collins at kcollins@exlpharma.com
or replace attendance badge with a colleague occurring within five business days of the conference.

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REGISTER TODAY . . .
Presents
The 3rd Reporting Aggregate
Spend & Sunshine Act
Compliance Conference
Strategies for Data Collection and Disclosure that Comply with Federal
and State Requirements in an Era of Health Care Reform
June 7-8, 2012 • Hyatt at The Bellevue • Philadelphia, PA
Featured Sessions:
ANALYZE THE NEW REGULATIONS ADDRESS THE ISSUE OF WHO, WHAT, WHERE, WHEN
RELEASED IN THE SUNSHINE ACT AND HOW TO REPORT AGGREGATE SPEND
Luanna Saulino, Associate Director, Disclosure Law & Transparency Operation,, BAYER Elizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, Global Operations,
JOHNSON & JOHNSON
LEARN BEST PRACTICES IN DATA TRACKING, Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency, Metrics,
COLLECTION, AND INTERNAL AUDITING & Reporting, JOHNSON & JOHNSON
Bill Friedrich, Director of State Reporting / TIG, External Medical Communications, PFIZER
Plus! Regulatory Panel Discussion
UNDERSTAND THE CHALLENGES PHYSICIANS FACE AS Updates from MN, VT and MD on Expectations for
A RESULT OF THE ADDITIONAL EXPOSURE Reporting Requirements under the Sunshine Act
Michael Varlotta, Senior Director Medical Education, JANSSEN SERVICES
TO REGISTER CALL 866-207-6528 OR VISIT WWW.EXLPHARMA.COM/AGGSPEND