1. EXCLUSIVE SESSIONS
gg EXAMINE THE AMARIN, PACIRA AND
CARONIA COURT CASES AND DISCUSS
THE IMPACT ON FIRST AMENDMENT SAFE
HARBORS IN THE OFF-LABEL MARKETING
ARENA
gg PRIORITIZE THE ESSENTIAL SKILL SETS
OF PROMOTIONAL REVIEW COMMITTEES
gg STEER CLEAR OF FDA WARNING LETTERS
gg CREATE COMPLIANT FIELD
REPRESENTATIVES
gg BUILD AN AIRTIGHT SOCIAL MEDIA
CAMPAIGN
2016
OFF-LABEL REGULATORY
COMPLIANCE CONGRESS
OFF-LABEL
COURT CASES
UPDATED
REGULATORY
GUIDELINES
PROMOTIONAL
REVIEW
COMMITTEESSCIENTIFIC
INFORMATION
EXCHANGE
COMPLIANT
OFF-LABEL
COMMUNICATION
SPONSORS:
Examine the FDA’s Revised Guidelines for Off-Label Promotion and Align Your Promotional
Practices to Remain Compliant in the Changing Regulatory Landscape
May 10-11, 2016 • Hilton Parsippany • Parsippany, NJ
Alan Bergstrom,
Executive Director,
Commercial Regulatory
Affairs, DAIICHI
SANKYO, INC.
Kevin Ryan,
Director, Compliance:
New Products,
NOVO NORDISK
Richard Liner,
Senior Counsel,
Compliance and
Investigations,
BAYER HEALTHCARE
Leslie Gladstone-
Restraino, General
Counsel/Lead Compliance
Counsel, VALIDUS
PHARMACEUTICALS
Sergio Alegre,
Executive Director of
Compliance,
PACIRA
PHARMACEUTICALS
Jeff New,
Associate Director,
Medical Affairs Business
Operations,
LUNDBECK
Conference Chair
To Register: Call 866-207-6528 or Visit www.exlevents.com/offlabel

2. DEAR COLLEAGUE,
In the wake of the recent Caronia, Amarin and Pacira cases, the industry anxiously awaits
the FDA’s official guidelines regarding the regulation of off-label promotional activities.
These verdicts may allow pharma companies to claim broader First Amendment rights,
which could be a huge win for the industry and patients. However, we must proceed with
caution. At ExL’s 2016 Off-Label Regulatory Compliance Congress, you will uncover the
challenges most likely to arise as your organization handles off-label promotion and walk
away with real-world solutions to implement at work.
Companies need to ready their business models for impending change. As we attempt to
navigate these uncharted waters, there is no better time to connect with your peers and
discuss tactics to create a culture of compliance at your organization. This must-attend
event will equip you with vital information and the guidance you need to maintain vigorous
compliance in your home office. Join us at this two-day event to:
• Get the most up-to-date information on the 2nd Circuit Court cases and their
potential impact on your compliance programs
• Identify best practices for training and monitoring compliant field representatives
• Learn how to build an airtight social media campaign and minimize the risks of
online activities
Together, industry experts will determine best practices to manage the risks of off-label
activities. We have packed the agenda with interactive sessions, panels and thought-
provoking discussions steered by industry thought leaders. You can’t afford to miss this
summit!
I look forward to seeing you this spring in New Jersey!
Sincerely,
Christy McCallion, M.S.
Christy McCallion, M.S.
Conference Production Director
ExL Events
WHO SHOULD ATTEND
This conference is designed for representatives
from pharmaceutical, medical device and
biotechnology companies with responsibilities
in the following areas:
gg Healthcare Compliance and Privacy
gg Compliance/Promotion Compliance
gg Regulatory Affairs/Regulatory Promotion/
Regulatory Advertising
gg Commercial Regulatory Affairs
gg Legal Affairs
gg MSL/Medical Affairs
gg Medical Information/Medical
Communications
gg Corporate Communications
gg Marketing/Marketing Operations/Marketing
Communications
gg Commercial Operations
gg Brand Management/Product Management/
Brand Marketing
gg Labeling
This event may also be of interest to:
gg Law Firms
gg Regulatory Consultants
gg Advertising/Marketing Agencies
gg CRM/Data Management Software Vendors
gg MLR Process Vendors and Facilitators
SPONSORSHIP AND
EXHIBITION OPPORTUNITIES
Do you want to spread the word about your
organization’s solutions and services to potential
clients who will be 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 Alexander Siegel,
Business Development Manager, at 917-242-3893 or
asiegel@exlevents.com.
VENUE INFORMATION HILTON PARSIPPANY
1 Hilton Court
Parsippany, NJ 07054
To make reservations, please call 800-445-8667 and request the
negotiated rate for ExL’s 6th Traceability/Off-Label Meetings or click
this link: http://bit.ly/offlabelcongress. The group rate is available until
April 18, 2016. Please book your room early, as rooms available at this
rate are limited.
*ExL Events, Inc. is not affiliated with Exhibition Housing Management
(EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies,
housing bureaus, or travel and events companies. In the event that an outside
party contacts you for any type of hotel or travel arrangements, please
disregard these solicitations and kindly email us at info@exlevents.com.
ExL has not authorized these companies to contact you and we do not verify
the legitimacy of the services or rates offered. Please book your guest rooms
through ExL’s reserved guest room block using the details provided.
2016
OFF-LABEL REGULATORY
COMPLIANCE CONGRESS
To Register: Call 866-207-6528 or Visit www.exlevents.com/offlabel

3. 8:00 Registration and Continental Breakfast
9:00 Chairperson’s Opening Remarks
CASE REVIEW: OFF-LABEL ADVERTISING AND THE COURTS
9:15 Examine the Amarin, Pacira and Caronia Court Cases and
Discuss the Impact on First Amendment Safe Harbors in
the Off-Label Marketing Arena
After Amarin and Pacira, we know that, at least as far as the 2nd
Circuit Court is concerned, the Caronia decision was no fluke. We
will discuss which changes are most likely to arise as pharma
companies begin to gain broader First Amendment rights. It is
imperative to examine the potential to disseminate information that
is accurate and non-misleading, even if it is off-label.
gg Analyze lessons learned from the 2nd Circuit — reviewing the
Amarin, Pacira and Caronia cases
gg Identify other jurisdictions where the Amarin case may be
challenged and possibly reversed
gg Determine how these cases will affect the FDA’s ability to regulate
company communications
gg Differentiate between what is possible under Amarin, what is
considered “at risk,” and what are the likely scenarios where the
dissemination of information may be considered broadening your
label and constitute off-label claims
Peter Pitts, President and Co-Founder, CENTER FOR MEDICINE
IN THE PUBLIC INTEREST
Howard Dorfman, Former Senior Vice President and General
Counsel, TURING PHARMACEUTICALS
RULES, REGULATIONS AND ENFORCMENT AGENGIES
10:15 The Impact of Coronia and It’s Aftermath on
Pharmaceutical Compliance and Marketing Programs: A
Trial Lawyer’s and Issues Management Perspective
In today's rapidly evolving marketplace, it's important to have a
thorough understanding of the legal and regulatory statutes that
govern the advertising, marketing and promotion of prescription
drugs and medical devices.
gg A Historical legal perspective on what led up to Caronia and
where the Courts are likely to go next.
gg A Trial lawyer’s perspective on how the Government and the
Courts will interpret Caronia et al. and the impact on in-house
marketing and compliance programs
gg A look at the impact of material disclosures to investors related
to off-label marketing investigations and how to pro-actively deal
with these issues.
gg A discussion of Press/Public reactions to Government
investigations and prosecutions and methods to craft your story
effectively.
David S. Stone, Esq., Senior Managing Partner, STONE &
MAGNANINI LLP
Thomas J. Rozycki, Jr., Managing Director, PROSEK
PARTNERS
11:15 Networking Break
11:45 A Guiding Overview: Compliance and Enforcement Risks of
Off-Label Promotion
Clarify which promotional practices will land your organization
in hot water and build compliance protocols into your advertising
campaign.
gg Navigate FDA guidance documents and the narrowness of off-
label safe harbor
gg Generate advertising and promotion materials with a complete
compliance guarantee
gg Hear about Return on Review (ROR), an audit metric on
unsolicited requests Williams © 2014
Jennifer Williams, Medical Director, Regulatory Affairs, MSL
Services, CR BARD
12:45 Luncheon
1:45 Mitigating Off-Label Compliance Risks in an Uncertain
Environment
It is essential to protect your organization from off-label promotional
violations. Developing compliant interdepartmental communication
practices is in your best interest.
gg Establish compliant coordination between commercial and
medical functions
gg Discuss limitations on the dissemination of pipeline and clinical
development information
gg Separate branded and unbranded messaging by disease state
gg Explore strategies for delivering health economic information
Richard Liner, Senior Counsel, Compliance and Investigations,
BAYER HEALTHCARE
2:45 Networking Break
3:30 Steer Clear of FDA Warning Letters
Learn the most common violations that receive warning letters
and how to avoid them at all costs. Protect your company from the
heightened scrutiny and consequences of an FDA warning letter.
gg Identify the risks and potential consequences of noncompliance
with regulatory requirements for promotional and advertising
materials and campaigns
gg Review examples of warning letters by performing a step-by-step
examination of each section
gg Prepare your response: establish tactics to address violations and
get your company back to business as usual
Alan Bergstrom, Executive Director, Commercial Regulatory Affairs,
DAIICHI SANKYO, INC.
4:15 Understand the FDA’s Draft Guidance on Reprints of
Scientific and Medical Publications
A comprehensive walkthrough of the FDA’s “Guidance for Industry
Distributing Scientific and Medical Publications on Risk Information
for Approved Prescription Drugs and Biological Products—
Recommended Practices.”
gg Discuss the types of permissible scientific exchange, including
what information manufacturers must disclose
gg Learn how to use scientific journals and professional conferences
to disseminate off-label uses
gg Uncover the policies and procedures applicable to your company
regarding the distribution of reprints
Gretchen Fritz, Associate General Counsel, Commercial Brands,
DAIICHI SANKYO
Niteesha Gupte, Assistant Professor, SETON HALL SCHOOL OF
LAW
5:00 Day One Concludes
MAIN CONFERENCE DAY ONE TUESDAY, MAY 10, 2016
"Great presentations and dynamics.
Comprehensive, valuable, extremely
relevant information."
—Project Manager, Regulatory Affairs, ABBVIE
To Register: Call 866-207-6528 or Visit www.exlevents.com/offlabel

4. 8:00 Continental Breakfast
9:00 Chairperson’s Recap of Day One
IN-HOUSE COMPLIANCE COMMUNICATION
9:15 PANEL: Create Compliant Field Representatives
As the face of your company, it is crucial for field representatives to
undergo compliance training. You must learn the best techniques to
ensure all communication regarding off-label information follows
regulatory guidelines.
gg Guide sales reps and promotional speakers to help them
understand the types of prohibited speech when promoting
products to HCPs
gg Learn how to respond to unsolicited requests for off-label
information about drugs and medical devices
Moderator:
Alan Bergstrom, Executive Director, Commercial Regulatory Affairs,
DAIICHI SANKYO, INC.
Sergio Alegre, Executive Director of Compliance, PACIRA
PHARMACEUTICALS
Tim Grimes, Healthcare Compliance Officer, JOHNSON &
JOHNSON
10:15 Predict And Respond To Off-Label Activity With A Proactive
Social Media Strategy
Controlling your company’s social media presence can be
overwhelming, especially now that regulatory scrutiny has focused
on off-label activities on Facebook, Twitter, Instagram, and other
platforms. The industry has been largely reactive in dealing with
these risks, but with effective processes, tools, and analytics,
companies can proactively monitor social media and the web for off-
label and other unlawful promotions.
gg Identify regulatory risk areas stemming from social media
engagement
gg Reveal potentially unlawful promotions through technology-
driven monitoring and analytics
gg Discover the benefits of a social media listening strategy to better
manage risk and engage with patients
Aditi Taylor, Advisory Principal, DELOITTE & TOUCHE LLP
Kirk Petrie, Advisory Principal, DELOITTE TRANSACTIONS AND
BUSINESS ANALYTICS LLP
Becca Ramble, Studio Senior Manager, DELOITTE CONSULTING
LLP
11:00 Networking Break
THE FUTURE OF COMPLIANT OFF-LABEL PROMOTIONS
11:30 Prioritize the Essential Skill Sets of Promotional Review
Committees
With off-label promotional activities in the spotlight, the importance
of a strong interdisciplinary team is crucial. Learn how to get the
most out of your Promotional Review Committee (PRC).
gg Foster greater collaboration between promotional regulatory/
legal professionals and marketing/product management teams
gg Assign dedicated roles to each team member to save time and
optimize PRC meetings
gg Incorporate novel strategies into your PRC’s standard operating
procedures
Lois Jessen, Director, Commercial Regulatory Affairs, EISAI
12:15 Luncheon
1:15 CASE STUDY: Innovations to Communicate Scientific
Information to Decision-Makers
Organizations are addressing the need for retooling communication
approaches for MSL interactions with healthcare decision-makers.
Hear about a pioneer program currently being implemented in
order to best prepare MSLs and teach them how to efficiently and
effectively respond to inquiries.
gg Learn about an “MSL Warm Transfer” pilot project to provide
more timely responses to spontaneous inquiries
gg Discuss the challenges MSLs and account managers face when
responding to scientific inquiries
gg Develop tools and techniques to aid MSLs in scientific
communication and ethical interactions
Jeff New, Associate Director, Medical Affairs Business Operations,
LUNDBECK
2:45 Risk Assessment Program Development and
Implementation
This session is an open discussion focused on Risk Assessment and
Mitigation Programs (RAMP).
gg Sell the idea of a RAMP to senior management
gg Explore the importance of Line of Business participation in your
RAMP
gg Consider why a RAMP makes good business sense
gg Discuss RAMP and the Yates Memo
gg Quantify the four most important inputs for your RAMP
gg Address RAMP and government obligations
Kevin Ryan, Corporate Counsel, NOVO NORDISK
PHARMACEUTICALS
2:45 PANEL: Compliance Tools for Implementation,
Maintenance and Troubleshooting
During this session, you will hear a panel of compliance
professionals address ways to:
gg Establish training programs, including online tools and tips for
rollout and documentation
gg Identify compliance department systems and databases to
help with program maintenance and tracking changes in laws,
regulations and industry guidances
gg Implement policies, processes and personnel for monitoring and
auditing programs
gg Create metrics and detect “red flags” for further review and
investigation
Leslie Gladstone-Restraino, General Counsel/Lead Compliance
Counsel, VALIDUS PHARMACEUTICALS
Jennifer A. Romanski, Esq. PORZIO, BROMBERG &
NEWMAN, P.C.
3:30 Chairperson’s Closing Remarks
3:45 Conference Concludes
MAIN CONFERENCE DAY TWO WEDNESDAY, MAY 11, 2016
"This is an excellent venue to have conversations that
otherwise would not be possible, from people who would
never meet. Even at other scientific meetings you don't have
this sort of conversation. This has been a very useful venue
for learning."
—Associate Director, AdProm Medical Affairs, Advertising and
Promotion, BAXTER
To Register: Call 866-207-6528 or Visit www.exlevents.com/offlabel

5. REGISTRATION INFORMATION
GROUP DISCOUNT PROGRAMS
*Offers may not be combined. Early Bird rates do not apply. To find out more about how
you can take advantage of these group discounts, please call 212-400-6240.*
Save 25%
For every three simultaneous registrations from your company, you will receive a fourth
complimentary registration to the program (must register four at one time).
Save 15%
Can only send three? You can still save 15% off of each registration.
REGISTRATION FEES
EARLY BIRD PRICING
Register by April 1, 2016 $1,895
STANDARD PRICING
Register After April 1, 2016 $2,095
ONSITE PRICING $2,195
MEDIA PARTNERS
QUESTIONS? COMMENTS?
Do you have a question or comment that you would like to be
addressed at this event? Would you like to get involved as a speaker
or discussion leader? Please email Conference Production Director
Christy McCallion, M.S., at cmccallion@exlevents.com.
TERMS AND CONDITIONS: By registering for an ExL Events, Inc. (“ExL”) event, you agree to the
following set of terms and conditions listed below:
REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated
continental breakfasts‚ lunches and refreshments.
PAYMENT: Make checks payable to ExL Events, Inc. and write C830 on your check. You may also
use Visa, MasterCard, Discover or American Express. Payments must be received in full by the
conference date. Any discount applied cannot be combined with any other offer and must
be paid in full at the time of order. Parties must be employed by the same organization and
register simultaneously to realize group discount pricing options.
**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or
replace attendance badges with a colleague within five business days of any ExL conference.**
CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL
event, the following policies apply, derived from the Start Date of the event:
• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another
ExL event valid for 12 months from the voucher issue date.
• Less than four weeks: A voucher to another ExL event valid for 12 months from the
voucher issue date.
• Five days or less: A voucher (minus a $395 processing and documentation fee) to another
ExL event valid for 12 months from the voucher issue date.
To receive a refund or voucher, please email cancel@exlevents.com or fax your request to
888-221-6750.
CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers
are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is
not used at time of registration, any remaining balance is not applicable now or in the future.
Once a credit voucher has been applied toward a future event, changes cannot be made. In
the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.
ExL Events, Inc. does not and is not obligated to provide a credit voucher to registered
attendee(s) who do not attend the event they registered for unless written notice of intent to
cancel is received and confirmed prior to the commencement of the event.
SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute,
exchange and/or replace attendee badges with a colleague occurring within five business
days of the conference.
ExL Events reserves the right to cancel any conference it deems necessary and will not be
responsible for airfare‚ hotel or any other expenses incurred by registrants.
ExL Events’ liability is limited to the conference registration fee in the event of a cancellation
and does not include changes in program date‚ content‚ speakers and/or venue.
*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies
they represent, nor ExL Events, Inc.
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, INC.
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.
WAYS TO REGISTER
Phone: 866-207-6528
Online: www.exlevents.com/offlabel
Email: registration@exlevents.com
Mail: ExL Events, Inc.
494 8th Ave, Fourth Floor
New York, NY 10001

6. EXCLUSIVE SESSIONS
gg Examine the Amarin, Pacira and Caronia Court Cases and
Discuss the Impact on First Amendment Safe Harbors in the
Off-Label Marketing Arena
gg Prioritize the Essential Skill Sets of Promotional Review
Committees
gg Steer Clear of FDA Warning Letters
gg Create Compliant Field Representatives
gg Build an Airtight Social Media Campaign
2016
OFF-LABEL REGULATORY
COMPLIANCE CONGRESS
Examine the FDA's Revised Guidelines for Off-Label Promotion and Align Your
Promotional Practices to Remain Compliant in the Changing Regulatory Landscape
May 10-11, 2016 • Hilton Parsippany • Parsippany, NJ
Conference Code: C830
Please contact me:
 I'm interested in marketing opportunities at this event.
 I wish to receive email updates on ExL Pharma's upcoming events.
Method of Payment:  Check  Credit Card
Make checks payable to ExL Events, Inc.
Card Type:  MasterCard Visa  Discover  AMEX
Card Number: Exp. Date:
Name on Card: CVV:
Signature:
 Yes! Register me for the conference.
Name: Title:
Company:
Dept.:
Address:
City: State: Zip:
Email:
Phone: Fax:
WAYS TO REGISTER
Phone: 866-207-6528
Online: www.exlevents.com/offlabel
Email: registration@exlevents.com
Mail: ExL Events, Inc.
494 8th Ave, Fourth Floor
New York, NY 10001
To Register: Call 866-207-6528 or Visit www.exlevents.com/offlabel