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Register Now | 888 224 2480 | FCPAconference.com/Pharma
a C5 Group Company
Business Information in a Global Context
April 27–28, 2016 | Park Lane Hotel | New York, NY
American Conference Institute’s 10th
Advanced Forum on
FCPA & ANTI-CORRUPTION
FOR THE LIFE SCIENCES INDUSTRY
EARN CLE/CPE
CREDITS
This year marks 30 years since the inception of C5 Group.
It is time to match our brand with the dynamic strides we have made.
See inside for details…
ACIAmerican Conference Institute
Business Information in a Global Context
Q & A at the Inaugural FCPA “Town Hall”: The
Latest Compliance Standards and How to
OvercomeProgramImplementationChallenges
Patrick Stokes
Senior Deputy Chief,
Fraud Section, Criminal Division
U.S. Department of Justice
Charles E. Cain
Deputy Chief, FCPA Unit
U.S. Securities and Exchange Commission
Meet and Benchmark with Experts
from Pharmaceutical, Medical Device,
Biotechnology Companies, and CROs:
GE Healthcare
Bayer
Hill-Rom
Zimmer Biomet
INC Research
Pfizer
NuVasive
Capsugel
Parexel
Arthrex
Gilead Sciences
Sponsored by: Exhibitor: Media Partner:
Unlike other events, this program is uniquely tailored to the life sciences
context. New topics and practical, interactive panels include:
•	 DATA TRANSFER CASE STUDIES — EU & CHINA: Transferring Sensitive Data for R & D, FCPA
Compliance and Investigative Purposes
•	 The Latest Trends in LIFE SCIENCES FCPA DECLINATIONS AND SETTLEMENTS
•	 FOREIGN GOVERNMENT R & D FUNDING AND REGULATORY APPROVALS: How to Manage
Complex FCPA Risks in the Public Procurement and Post-Market Contexts
•	 EU SUNSHINE REPORTING Statistics and Best Practices
•	 CRO COMPLIANCE: The Latest Best Practices for Minimizing Pre- and Post-Market Corruption Risks
•	 THIRD PARTIES UNDER THE MICROSCOPE: Due Diligence and Monitoring Best Practices
NEW INTERNATIONAL ANTI-CORRUPTION PANELS:
•	 EASTERN EUROPE — How Life Sciences Companies are Tailoring Their Programs to the Risks
and Realities on the Ground
•	 INDIA — Managing New Regulatory Changes and Rising Whistleblower Allegations
•	 Business Development in CHINA, BRAZIL & MEXICO: Case Studies and Hypothetical Exercises
BENEFIT FROM PRACTICAL, IN-DEPTH WORKING GROUPS
TUESDAY, APRIL 26, 2016:
A	 A Complete Guide to EU Data Privacy Laws and
the Safe Harbor Program
B	Third Party Audits from A to Z
Join the Conversation @ACI_Pharma #ACIFCPA ACI Pharmaceuticals/Biotech/Life Sciences Experts
ACIAmerican Conference Institute
Business Information in a Global Context
This year marks 30 years since the inception of C5 Group.
It is time for a brand, logo and language in keeping with the
dynamic strides we have made as a company. It is time for a
brand that will take us forward for the next 30 years.
C5 Group, comprising American Conference Institute, The
Canadian Institute and C5 in Europe, will unite under one
central brand image, appropriately a globe. See how bringing
together the power of people and the power of information can
accelerate your growth and success.
Our new brand look and language will be fully revealed soon.
Stay tuned for more exciting changes.
30 years
expanding
across
the globe
30 years
building a
network of
industry leaders
30 years
hosting more
than 6,000
conferences
WHO YOU WILL MEET
Pharmaceutical, Biotech, CRO and Medical Device
Professionals Responsible for:
•	FCPA and Anti-Corruption
•	International Trade and Regulation
•	Global Compliance and Training
•	Legal & Regulatory Affairs and Enforcement
•	Internal Audits and Investigations
•	Ethics and Compliance
Law Firm Counsel Practicing in:
•	FCPA and Anti-Corruption
•	Government Investigations
•	White Collar Crime
•	International Trade and Regulation
•	Life Sciences
U.S. and international enforcement authorities have continued their vigorous pursuit of life sciences
companies for FCPA and anti-corruption violations, resulting in recent high profile investigations across
the globe and heightened government compliance expectations.
In response to this daunting climate, ACI’s 10th
Advanced Conference on FCPA & Anti-Corruption for the Life Sciences
Industry provides a forum for critical networking and benchmarking on how to combat the next wave of global
anti-corruption and related risk factors confronting the industry.
We are pleased to announce that the Government and industry faculty has been updated for 2016:
Government Keynote Faculty
Charles E. Cain
Deputy Chief, FCPA Unit, U.S. Securities and Exchange Commission
Patrick Stokes
Senior Deputy Chief, Fraud Section, Criminal Division, U.S. Department of Justice
Speaker Faculty from the U.S. and Abroad Includes:
Erik Sandstedt
VP & Assistant General Counsel, Global Investigations, Pfizer
Mihai G. Popa
Country Group Romania/Bulgaria/Moldova— Law,Patents and Compliance, Bayer (Romania)
Carrie Ann Ashcom
Director, Global Compliance Monitoring, Zimmer Biomet
Keir Strauss
Assistant General Counsel, Compliance & Ethics, INC Research
Kristina Ahern
Compliance Manager, Auditing & Monitoring, Hill-Rom
Rodrigo Grion
Global Head of Monitoring, GE Healthcare
Patricia Gatley
Director of Global Compliance, NuVasive
Stacey J. Hanna
Assistant General Counsel and Director of Global Compliance, CAPSUGEL
Dennis Barnes
VP and Chief Compliance Officer, PAREXEL
Shawn Lichaa
Legal Counsel, Gilead Sciences
Janice Avery
Foreign Corrupt Practices Act Manager, Arthrex
Zachary N. Coseglia
Assistant General Counsel, Global Investigations, China Lead, Pfizer
Due to popular demand, this event is expected to sell out. Register today by calling 888-224-2480
or register on line at FCPAconference.com/Pharma.
Register Now | 888 224 2480 | FCPAconference.com/Pharma
a C5 Group Company
Business Information in a Global Context
Working Group A
9:00 a.m. – 12:30 p.m. (Registration opens at 8:30 a.m.)
A Complete Guide to EU Data Privacy Laws and the Safe
Harbor Program
David J. Kessler
Partner, Co-Chair — E-Discovery and Information Governance Practice
Norton Rose Fulbright US LLP (New York, NY)
Emmanuel Ronco
Counsel
Cleary Gottlieb Steen & Hamilton LLP (Paris, France)
At this in-depth working group, data privacy experts will take you through the ins
and outs of how to interpret and apply highly complex data privacy restrictions
across EU member countries. Through a review of relevant legislation and cases,
you will be brought up-to-speed on the myriad of different requirements affecting
data protection, storage and transfers.
Participants will also benefit from helpful resource materials and extended
Q & A. The expert speakers will also take you through case studies and concrete
examples affecting the life sciences industry. Topics to be discussed include:
•	 Contrasting UK, French, German and other member country data
privacy laws
•	 Trends in how EU regulators have interpreted data privacy
•	 Capturing and preserving electronic information
•	 Handling conflicting data privacy laws
•	 Key restrictions on transmitting data across borders
•	 The future of harmonized data protection in the EU
•	 Restrictions on screening potential candidates for internships, boards
and employment
•	 Navigating privacy law constraints on interviewing and hiring
•	 Limits on setting up databases to track ongoing investigations
and hotline calls
Working Group B
1:30 p.m. – 5:00 p.m. (Registration opens at 1:00 p.m.)
Third Party Audits from A to Z: How to Develop,
Implement and Measure the Success of Your Third Party
Audit Program in High Risk Markets
Janice Avery
Foreign Corrupt Practices Act Manager
Arthrex Inc. (Naples, FL)
Edward J. Fishman
Partner
K & L Gates (Washington, DC)
Whether you are new to the area of third party FCPA audits or a seasoned
professional, it is always worthwhile to stay up-to-speed on the latest best
practices for conducting an audit and overcoming real-life challenges affecting
the process. At this highly anticipated working group, you will gain legal and
compliance insights on how to develop, implement and strengthen your third
party audit program.
The Working Group Leaders will focus on jurisdictions that have presented
heightened obstacles to conducting successful third party audits-and how
life sciences companies have addressed these issues on the ground. Topics for
discussion will include:
•	 Incorporating contractual audit rights into your compliance structure
•	 How to perform audits on longstanding vs. new business partners
•	 When audits should be done a routine basis vs. only if there
is a potential issue
•	 Ensuring that the audit is an independent and documented process
•	 How to evaluate third party compliance with FCPA, and contractual terms
and conditions:
-	 examining compliance programs and codes of conduct
-	 books, records and accounts of the third party
-	 third party subsidiaries, joint ventures or affiliates
-	 testing for gifts, travel and entertainment
-	 reviewing expense reports for employees in high-risk positions or countries
-	 examining commission payments and petty cash activity
-	 analyzing the general ledger for high-risk transactions and cash advances
PRE-CONFERENCE WORKING GROUPS
Tuesday, April 26, 2016
Exclusive Room Rates!
American Conference Institute is pleased to offer our delegates a limited
number of hotel rooms at a preferential rate. Please contact the hotel directly
and mention the FCPA conference to receive this rate.
Continuing Professional Education Credits
American Conference Institute (ACI) will apply for Continuing
Professional Education credits for all conference attendees who
request credit. There are no pre-requisites and advance preparation is
not required to attend this conference.
Course objective: Update on the FCPA and applicable anticorruption
laws and procedures to prevent inappropriate payments. Prerequisite:
None. Level of knowledge: Beginner/Intermediate. Teaching Method:
Group-Live. Advanced Preparation: None. Delivery method: Group Live.
Please refer to the information in this brochure for outline, course
content and objectives. Final approval of a course for CPE credits belongs with
each states’ regulatory board. Recommended CPE Credit: 14.5 hours for the main
conference and an additional 4.0 hours for each workshop.
ACI is registered with the National Association of State Boards of Accountancy
(NASBA) as a sponsor of continuing professional education on the National Registry
of CPE Sponsors. State boards of accountancy have final authority on the acceptance
of individual courses for CPE credit. Complaints regarding registered sponsors may be
addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite
700, Nashville, TN, 37219-2417 or by visiting the web site: www.learningmarket.org
To request credit, please check the appropriate box on the Registration form.
Continuing Legal Education Credits
Accreditation will be sought in those jurisdictions requested by
the registrants which have continuing education requirements.
This course is identified as nontransitional for the purposes of
CLE accreditation.
ACI certifies that the activity has been approved for CLE credit by the New York State
Continuing Legal Education Board.
ACI certifies that this activity has been approved for CLE credit by the State Bar of
California.
You are required to bring your state bar number to complete the appropriate state forms
during the conference. CLE credits are processed in 4-8 weeks after a conference is
held.
ACI has a dedicated team which processes requests for state approval. Please note
that event accreditation varies by state and ACI will make every effort to process your
request.
Questions about CLE credits for your state? Visit our online CLE Help Center at www.
americanconference.com/CLE
EARN CLE
CREDITS
Join the Conversation @ACI_Pharma #ACIFCPA ACI Pharmaceuticals/Biotech/Life Sciences Experts
DAY ONE
Wednesday
April 27, 2016
8:30
Opening Remarks from the Co-Chairs
Erik Sandstedt
Vice President & Assistant General Counsel,
Global Investigations
Pfizer Inc. (New York, NY)
Bret Campbell
Partner	
Cadwalader, Wickersham, & Taft LLP
(Washington, DC)
8:45
FCPA COMPLIANCE TOWN HALL: The Latest FCPA
Compliance Standards and How to Overcome
Program Implementation Challenges
Patrick Stokes
Senior Deputy Chief,
Fraud Section, Criminal Division
U.S. Department of Justice (Washington, DC)
Charles E. Cain
Deputy Chief, FCPA Unit
U.S. Securities and Exchange Commission
(Washington, DC)
Nathaniel Edmonds
Partner
Paul Hastings LLP (Washington, D.C.)
New for 2016, participants will have an enhanced
opportunity to ask their questions and engage in
discussion with key Government decision-makers.
Take this opportunity to gain the latest updates on
FCPA compliance expectations and participate in
extended Q & A with the key agencies. You are also
welcome to submit your questions in advance to
FCPA@americanconference.com
10:00
Networking Coffee Break
10:15
DATA TRANSFERS — EU & CHINA
Case Studies & Hypothetical Exercises —
Determining When and How to Transfer
Sensitive Data for R & D, FCPA Compliance
and Investigative Purposes
Zachary N. Coseglia
Assistant General Counsel
Global Investigations, China Lead
Pfizer (New York, NY)
Yaniss Aiche
Counsel
SheppardMullin (Brussels, Belgium)
Kathleen Hamann
Partner
White & Case LLP (Washington, DC)
Through practical scenarios and concrete examples,
the esteemed panel will focus on how to manage
complex challenges in the EU and China affecting
cross-border data transfers. Themes will include:
•	 Meeting U.S. agencies’ expectations for
cooperation amid conflicting EU data privacy
restrictions
•	 How to properly investigate bribery without
committing a criminal act under foreign data
privacy laws
•	 Monitoring your compliance program and
investigations database to avoid privacy law
violations
•	 Special considerations affecting the R & D
process and how to address them
11:30
TRENDS IN LIFE SCIENCES FCPA DECLINATIONS
AND SETTLEMENTS: Taking Stock of Penalty
Trends, Corrective Actions and What Has
Triggered a US DOJ Declination
James Koukios
Partner
Morrison & Foerster LLP (Washington, DC)
Former Senior Deputy Chief, Fraud Section,
Criminal Division, US DOJ
Frederic D. Firestone
Partner
McDermott Will & Emery (Washington, DC)
Former Associate Director, Division of Enforcement,
SEC
•	 Contrasting US DOJ vs. SEC investigative
techniques
•	 What has led to a US DOJ declination vs. an
SEC settlement
•	 Recent key cases and what they reveal about
evolving government FCPA compliance
expectations
•	 New, emerging grounds for enforcement
•	 Increased enforcement of the books and records
provisions by the SEC, and priorities going
forward
•	 What is expected from your company if your
industry is under investigation
•	 How compliance efforts are rewarded
12:30
Networking Luncheon for Attendees
& Speakers
1:45
EASTERN EUROPE — How Life Sciences
Companies are Tailoring Their Anti-Corruption
Compliance Programs to Industry-Specific
Risks and Realities on the Ground
Mihai G. Popa
Country Head of Law, Patents and Compliance
Country Group Romania/Bulgaria/Moldova —
Law, Patents and Compliance
Bayer (Bucharest, Romania)
Livia Zamfiropol
Partner
DLA Piper (Bucharest, Romania)
Sandra Bjegovic
Regional Compliance Director – Investigations
Compliance Division
Pfizer Inc. (New York, NY)
Bret Campbell — Panel Moderator
Partner
Cadwalader, Wickersham, & Taft LLP
(Washington, DC)
•	 Updates on the legislative, regulatory and
enforcement landscapes in the region, including
Poland, Hungary, Romania and Bulgaria
•	 Status of the “industry sweep” in Romania
•	 New transparency rules and their impact
•	 Limitations on sponsorship and travel for
medical professionals
•	 How to respond to Romanian Government
requests for information about interactions
with doctors
•	 The varying public procurement processes in
each country and best practices for interacting
with procurement officials
•	 The realities on the ground: The most significant
corruption risk factors in the region and how to
minimize them
2:45
ROUNDTABLE DISCUSSION — Third Party FCPA
Audit “War Stories” and Lessons Learned:
Industry Experts Reveal What They Wish They
Knew Then That They Know Now
Kristina Ahern
Compliance Manager, Auditing & Monitoring
Global Compliance Office
Hill-Rom (Chicago, IL)
Rodrigo Grion
Global Head of Monitoring
GE Healthcare (Waukesha, WI)
At this interactive session, industry experts with
extensive third party audit experience will discuss
the biggest lessons learned when preparing for and
conducting a third party audit. Through anecdotal
insights, they will focus on the real-life challenges
that they have encountered and how they addressed
them.
This session is specifically designed to foster audience
participation, so please bring your questions!
3:30
Networking Coffee Break
3:45
THE NEW FACE OF ANTI-CORRUPTION
COMPLIANCE IN INDIA: Managing the Practical
Impact of New Local Regulatory Changes and
Rising Whistleblower Allegations
Anand Prasad
Partner
Trilegal (New Delhi, India)
Register Now | 888 224 2480 | FCPAconference.com/Pharma
a C5 Group Company
Business Information in a Global Context
Stacey J. Hanna
Assistant General Counsel and
Director of Global Compliance
CAPSUGEL (Morristown, NJ)
James W. Haldin
Counsel
Davis Polk & Wardwell LLP (Washington, DC)
•	 Practical review of Reports No. 254 & 258 of the
Law Commission of India
•	 How companies can transform their compliance
strategy and prepare for a new legislative
landscape
•	 Provisions under the new Companies Act, 2013
which focus on anti-bribery and how to update
your compliance programme accordingly
•	 The Lokpal & Lokayukta Act, 2013 and changes
made to the Prevention of Corruption Act, 1988
•	 India’s Whistleblower Protection Act: Best
practices for responding to the anonymous
whistleblower
•	 How to overcome local challenges to rolling out
your program: Balancing cultural norms with
global policies and requirements
4:45
FOREIGN GOVERNMENT R & D FUNDING AND
REGULATORY APPROVALS: How to Manage
Complex FCPA Risks in the Public
Procurement and Post-Market Contexts
Patricia Gatley
Director of Global Compliance
NuVasive (San Diego, CA)
Brian E. Kowalski
Partner
Latham & Watkins LLP (Washington, DC)
•	 Understanding which licenses, permits or
certifications are legally required in order to
identify fabricated requests for payment
•	 What role can/should third parties play to assist
in obtaining approvals and what is the liability
for third party actions
•	 How to handle requests for donations and
political contributions
•	 What role should your government affairs play in
vetting requests for political contributions
•	 Responding to and addressing competitor
allegations of bribery in the context of a large
government contract bidding process
•	 Resolving anti-corruption compliance challenges
in local community development projects
5:30
Conference Adjourns
DAY TWO
Thursday
April 28, 2016
8:45
Co-Chairs’ Opening Remarks
9:00
KEYNOTE ADDRESS: Debarment for FCPA and
Healthcare Regulatory Violations: Government
Speaks on Their Decision-Making Process
When Assessing Life Sciences Companies’
Compliance Efforts
Douglas Stearn
Director
Office of Enforcement and Import Operations
U.S. Food and Drug Administration (Washington, DC)
9:20
INTERACTING WITH HCPs: Big Picture, Strategic
Insights for Ethical Business Conduct,
Anti-Corruption and Healthcare Compliance
Dennis Barnes
Vice President and Chief Compliance Officer
PAREXEL International Corporation (Waltham, MA)
Gary DiBianco
Partner
Skadden, Arps, Slate, Meagher & Flom LLP
(Washington, DC)
At this opening session, the esteemed panelists
will provide high level insights on how to dovetail
your ethics policies, anti-corruption and regulatory
compliance programs for a fully integrated, global
strategy for HCP interactions. The discussions will,
in part, focus on tailoring your approach to the
unique contexts of high risks markets, and will offer
concrete examples and lessons learned.
10:15
Networking Coffee Break
10:30
THIRD PARTIES UNDER THE MICROSCOPE:
Due Diligence and Monitoring Best Practices
Carrie Ann Ashcom
Director, Global Compliance Monitoring
Zimmer Biomet (Warsaw, IN)
Shawn Lichaa
Legal Counsel
Gilead Sciences (San Francisco, CA)
Jacqueline C. Wolff - Panel Moderator
Partner
Manatt, Phelps & Phillips, LLP (New York, NY)
This practical panel will focus on how to manage the
evolving risks and approaches to onboarding and
monitoring the following types of third parties:
•	 Sales Representatives
•	Distributors
•	 Law firms and other outside advisors
•	Agents
•	 Customs Brokers
•	Lobbyists
11:45
UK BRIBERY ACT AND THE “ADEQUATE
PROCEDURES DEFENSE”: What the First
Corporate DPA and Recent Cases Reveal
about Cooperation and Internal Controls
Requirements
Matthew Howard Getz
International Counsel
Debevoise & Plimpton (London, UK)
•	 The ins and outs, and impact of the first
corporate DPA, and what it means for
enforcement in the UK going forward
•	 New, emerging enforcement risks affecting the
life sciences industry
•	 How the SFO has interpreted “cooperation”
•	 Best practices for applying the internal
controls, books and records provisions of the
UK Bribery Act
•	 What the SFO has required for the “adequate
procedures” defense
•	 Justifying your compliance efforts to the SFO:
Concrete examples
12:30
Networking Luncheon for Attendees
and Speakers
1:30
UPDATES ON CRO COMPLIANCE: The Latest Best
Practices for Minimizing Pre- and Post-
Market Corruption Risks
Keir Strauss
Assistant General Counsel, Compliance & Ethics
INC Research (Raleigh, NC)
Eric Kraeutler
Partner
Morgan, Lewis & Bockius LLP (Philadelphia, PA)
Gary Giampetruzzi
Partner
Paul Hastings LLP (New York, NY)
•	 Managing evolving bribery risks facing CROs
and others in the supply chain
•	 To what extent a sponsor can rely on the CRO’s
compliance program vs. conduct due diligence
and monitoring
•	 Update on what CROs are doing to prevent
improper payments, and reduce bribery risks
when interacting with government officials, and
seeking clinical trial and marketing approvals
•	 Concrete examples of effective CRO policies and
anti-corruption compliance programs
•	 Reducing the risk of sponsors’ derivative FCPA
liability due to CRO non-compliance
Join the Conversation @ACI_Pharma #ACIFCPA ACI Pharmaceuticals/Biotech/Life Sciences Experts
© American Conference Institute, 2016
2:30
HYPOTHETICAL EXERCISES — Growing Your
Business in China, Brazil and Mexico:
Practical Solutions for Managing High
Risk Scenarios Affecting Your Operations,
Transactions, Clinical Trials and Local
Reporting Obligations
Marcio Mello Silva Baptista
Partner
Tozzini Freire Advogados (New York, NY)
Tiana Zhang
Partner
Kirkland & Ellis International LLP (Shanghai, China)
David Resnicoff
Partner
Schiff Hardin LLP (Chicago, IL)
Through a review of common transactions that pose
significant corruption risks — the use of distributors
and promotional interactions with healthcare
professionals — the expert speakers will impart
best practices and practical tools for minimizing
FCPA and anti-corruption risks in China, Brazil and
Mexico. In addition, the panelists will highlight risks
that are unique to each of these important markets
and explain how best to tailor your compliance
strategies to each jurisdictional context.
3:30
Networking Coffee Break
3:45
Lessons Learned from EU SUNSHINE REPORTING
Statistics and Best Practices
Katie C. Pawlitz
Partner
Reed Smith (Washington, DC)
•	 Update on the EU statistics specific to
anti-corruption and what they mean for
the life sciences industry
•	 Status of new, pending transparency laws and
other transparency mandates in the EU
•	 When will a violation or non-disclosure under
the French act result translate into an FCPA or
other U.S. legal violation?
•	 Managing the conflicts between Sunshine
reporting and data privacy laws
With more than 300 conferences in the United States,
Europe, Asia Pacific, and Latin America, American
Conference Institute (ACI) provides a diverse portfolio
devoted to providing business intelligence to senior
decision makers who need to respond to challenges
spanning various industries in the US and around
the world.
As a member of our sponsorship faculty, your
organization will be deemed as a partner. We will
work closely with your organization to create the
perfect business development solution catered
exclusively to the needs of your practice group,
business line or corporation.
For more information about this program or our
global portfolio of events, please contact:
Wendy Tyler
Director of Sales
American Conference Institute
Tel: 212-352-3220 x5242
w.tyler@AmericanConference.com
TURKEY
POLAND
IRELAND
CHINA
UNITED STATES
SFA 100
AUS 150
BAR 6
Pharma
Law Fir
Medical
CRO (C
Health C
14%
3%
7%
60%
16%
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TURKEY
POLAND
IRELAND
CHINA
UNITED STATES
USA 150
CAN 50 FRA 50
BRA 150
SFA 100
AUS 150
CHN 100
BAR 6
CIRCLE
Pharmaceutical Companies
Law Firm
Medical Devices
CRO (Contract Research Organizations
Health Care Networks/Systems
14%
3%
7%
60%
16%
H
Eas
Delec
90's
fund,
churc
proid
De
he
De
he
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OPTION FOUR
100%
100%
100%
100%
100%
100%
100%
100%
Global Sponsorship
Opportunities
4:30
FCPA AND ECONOMIC SANCTIONS:
Leveraging Internal Screening and Healthcare
Compliance Resources to Reduce US DOJ,
SEC and OFAC Penalty Risks
J. Patrick Rowan
Partner
McGuireWoods (Washington, DC)
Danish Hamid
Partner
Cooley LLP (Washington, DC)
•	 How economic sanctions compliance intersects
with healthcare and FCPA compliance
•	 Impact of recent developments in FCPA compliance
•	 Managing overlapping sanctions and FCPA
risks posed by distributor and other third party
relationships
•	 List management: How to leverage OFAC and
other lists for effective screening and re-screening
of existing and new business partners
•	 When an FCPA investigation can trigger
economic sanctions enforcement, and vice versa
5:15
Conference Concludes
Here’s who you can expect to network,
benchmark and learn from this April’s
FCPA & Anti-Corruption for the Life
Sciences Industry event:
AUDIENCE PROFILE
Meet with a Global Audience. Over the last 4 years, delegates from
5 countries have attended ACI’s FCPA & Anti-Corruption for the
Life Sciences Industry event:
a C5 Group Company
Business Information in a Global Context
o I would like to receive CLE accreditation for the following states:					. See CLE details inside.
o I would like to receive CPE accreditation for the following states:					. See CPE details inside.
Complete Payment Details4
Bringing a Team?
3 - 4 10% Conference Discount
5 - 6 15% Conference Discount
7 20% Conference Discount
7 or more Call 888-224-2480
Payment Policy
Payment must be received in full by the program date to ensure
admittance. All discounts will be applied to the Program Only fee
(excluding add-ons), cannot be combined with any other offer, and
must be paid in full at time of order. Group discounts available to 3 or
more individuals employed by the same organization, who register at
the same time.
Delegate Substitutions and Cancellations
Youmustnotifyusbyemailatleast48hrsinadvanceoftheconference
if you wish to send a substitute participant. If you are unable to find
a substitute, please notify us in writing no later than 10 days prior
to the conference date. All cancellations received will be subject to a
cancellation fee of $350. Delegates opting to receive a credit voucher
will receive a credit for the full amount paid, redeemable against
any other American Conference Institute conference in the next 12
months.
No credits or refunds will be given for cancellations received within 10
days of the conference start date. Delegates may not “share” a pass
between multiple attendees without prior authorization. No liability is
assumed by American Conference Institute for changes in program
date, content, speakers or venue. American Conference Institute
reserves the right to cancel any conference it deems necessary and
will,in such event,make a full refund of any registration fee,but will not
be responsible for airfare, hotel or other costs incurred by registrants.
Terms and Conditions
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Anti-Corruption Compliance
in High Risk Markets
July 2016
WASHINGTON,DC
MARK YOUR CALENDAR FOR THE FOLLOWING ACI ANTI-CORRUPTION EVENTS:
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Practices Act
May 16-17, 2016
NEWYORK
Brazil Summit on
Anti-Corruption
May 24-25, 2016
SAO PAULO
to register for these events and more, visit AntiCorruptionConferences.com
April 27–28, 2016 | Park Lane Hotel | New York, NY
April 27–28, 2016
Park Lane Hotel | New York, NY
American Conference Institute’s 10th
Advanced Forum on
FCPA & ANTI-CORRUPTION
FOR THE LIFE SCIENCES INDUSTRY
American Conference Institute’s 10th
Advanced Forum on
FCPA & ANTI-CORRUPTION
FOR THE LIFE SCIENCES INDUSTRY
895L16.E
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This year marks 30 years since the inception of C5 Group.
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ACIAmerican Conference Institute
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American Conference Institute’s 10th Advanced Forum on FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY

  • 1. Register Now | 888 224 2480 | FCPAconference.com/Pharma a C5 Group Company Business Information in a Global Context April 27–28, 2016 | Park Lane Hotel | New York, NY American Conference Institute’s 10th Advanced Forum on FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY EARN CLE/CPE CREDITS This year marks 30 years since the inception of C5 Group. It is time to match our brand with the dynamic strides we have made. See inside for details… ACIAmerican Conference Institute Business Information in a Global Context Q & A at the Inaugural FCPA “Town Hall”: The Latest Compliance Standards and How to OvercomeProgramImplementationChallenges Patrick Stokes Senior Deputy Chief, Fraud Section, Criminal Division U.S. Department of Justice Charles E. Cain Deputy Chief, FCPA Unit U.S. Securities and Exchange Commission Meet and Benchmark with Experts from Pharmaceutical, Medical Device, Biotechnology Companies, and CROs: GE Healthcare Bayer Hill-Rom Zimmer Biomet INC Research Pfizer NuVasive Capsugel Parexel Arthrex Gilead Sciences Sponsored by: Exhibitor: Media Partner: Unlike other events, this program is uniquely tailored to the life sciences context. New topics and practical, interactive panels include: • DATA TRANSFER CASE STUDIES — EU & CHINA: Transferring Sensitive Data for R & D, FCPA Compliance and Investigative Purposes • The Latest Trends in LIFE SCIENCES FCPA DECLINATIONS AND SETTLEMENTS • FOREIGN GOVERNMENT R & D FUNDING AND REGULATORY APPROVALS: How to Manage Complex FCPA Risks in the Public Procurement and Post-Market Contexts • EU SUNSHINE REPORTING Statistics and Best Practices • CRO COMPLIANCE: The Latest Best Practices for Minimizing Pre- and Post-Market Corruption Risks • THIRD PARTIES UNDER THE MICROSCOPE: Due Diligence and Monitoring Best Practices NEW INTERNATIONAL ANTI-CORRUPTION PANELS: • EASTERN EUROPE — How Life Sciences Companies are Tailoring Their Programs to the Risks and Realities on the Ground • INDIA — Managing New Regulatory Changes and Rising Whistleblower Allegations • Business Development in CHINA, BRAZIL & MEXICO: Case Studies and Hypothetical Exercises BENEFIT FROM PRACTICAL, IN-DEPTH WORKING GROUPS TUESDAY, APRIL 26, 2016: A A Complete Guide to EU Data Privacy Laws and the Safe Harbor Program B Third Party Audits from A to Z
  • 2. Join the Conversation @ACI_Pharma #ACIFCPA ACI Pharmaceuticals/Biotech/Life Sciences Experts ACIAmerican Conference Institute Business Information in a Global Context This year marks 30 years since the inception of C5 Group. It is time for a brand, logo and language in keeping with the dynamic strides we have made as a company. It is time for a brand that will take us forward for the next 30 years. C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, will unite under one central brand image, appropriately a globe. See how bringing together the power of people and the power of information can accelerate your growth and success. Our new brand look and language will be fully revealed soon. Stay tuned for more exciting changes. 30 years expanding across the globe 30 years building a network of industry leaders 30 years hosting more than 6,000 conferences WHO YOU WILL MEET Pharmaceutical, Biotech, CRO and Medical Device Professionals Responsible for: • FCPA and Anti-Corruption • International Trade and Regulation • Global Compliance and Training • Legal & Regulatory Affairs and Enforcement • Internal Audits and Investigations • Ethics and Compliance Law Firm Counsel Practicing in: • FCPA and Anti-Corruption • Government Investigations • White Collar Crime • International Trade and Regulation • Life Sciences U.S. and international enforcement authorities have continued their vigorous pursuit of life sciences companies for FCPA and anti-corruption violations, resulting in recent high profile investigations across the globe and heightened government compliance expectations. In response to this daunting climate, ACI’s 10th Advanced Conference on FCPA & Anti-Corruption for the Life Sciences Industry provides a forum for critical networking and benchmarking on how to combat the next wave of global anti-corruption and related risk factors confronting the industry. We are pleased to announce that the Government and industry faculty has been updated for 2016: Government Keynote Faculty Charles E. Cain Deputy Chief, FCPA Unit, U.S. Securities and Exchange Commission Patrick Stokes Senior Deputy Chief, Fraud Section, Criminal Division, U.S. Department of Justice Speaker Faculty from the U.S. and Abroad Includes: Erik Sandstedt VP & Assistant General Counsel, Global Investigations, Pfizer Mihai G. Popa Country Group Romania/Bulgaria/Moldova— Law,Patents and Compliance, Bayer (Romania) Carrie Ann Ashcom Director, Global Compliance Monitoring, Zimmer Biomet Keir Strauss Assistant General Counsel, Compliance & Ethics, INC Research Kristina Ahern Compliance Manager, Auditing & Monitoring, Hill-Rom Rodrigo Grion Global Head of Monitoring, GE Healthcare Patricia Gatley Director of Global Compliance, NuVasive Stacey J. Hanna Assistant General Counsel and Director of Global Compliance, CAPSUGEL Dennis Barnes VP and Chief Compliance Officer, PAREXEL Shawn Lichaa Legal Counsel, Gilead Sciences Janice Avery Foreign Corrupt Practices Act Manager, Arthrex Zachary N. Coseglia Assistant General Counsel, Global Investigations, China Lead, Pfizer Due to popular demand, this event is expected to sell out. Register today by calling 888-224-2480 or register on line at FCPAconference.com/Pharma.
  • 3. Register Now | 888 224 2480 | FCPAconference.com/Pharma a C5 Group Company Business Information in a Global Context Working Group A 9:00 a.m. – 12:30 p.m. (Registration opens at 8:30 a.m.) A Complete Guide to EU Data Privacy Laws and the Safe Harbor Program David J. Kessler Partner, Co-Chair — E-Discovery and Information Governance Practice Norton Rose Fulbright US LLP (New York, NY) Emmanuel Ronco Counsel Cleary Gottlieb Steen & Hamilton LLP (Paris, France) At this in-depth working group, data privacy experts will take you through the ins and outs of how to interpret and apply highly complex data privacy restrictions across EU member countries. Through a review of relevant legislation and cases, you will be brought up-to-speed on the myriad of different requirements affecting data protection, storage and transfers. Participants will also benefit from helpful resource materials and extended Q & A. The expert speakers will also take you through case studies and concrete examples affecting the life sciences industry. Topics to be discussed include: • Contrasting UK, French, German and other member country data privacy laws • Trends in how EU regulators have interpreted data privacy • Capturing and preserving electronic information • Handling conflicting data privacy laws • Key restrictions on transmitting data across borders • The future of harmonized data protection in the EU • Restrictions on screening potential candidates for internships, boards and employment • Navigating privacy law constraints on interviewing and hiring • Limits on setting up databases to track ongoing investigations and hotline calls Working Group B 1:30 p.m. – 5:00 p.m. (Registration opens at 1:00 p.m.) Third Party Audits from A to Z: How to Develop, Implement and Measure the Success of Your Third Party Audit Program in High Risk Markets Janice Avery Foreign Corrupt Practices Act Manager Arthrex Inc. (Naples, FL) Edward J. Fishman Partner K & L Gates (Washington, DC) Whether you are new to the area of third party FCPA audits or a seasoned professional, it is always worthwhile to stay up-to-speed on the latest best practices for conducting an audit and overcoming real-life challenges affecting the process. At this highly anticipated working group, you will gain legal and compliance insights on how to develop, implement and strengthen your third party audit program. The Working Group Leaders will focus on jurisdictions that have presented heightened obstacles to conducting successful third party audits-and how life sciences companies have addressed these issues on the ground. Topics for discussion will include: • Incorporating contractual audit rights into your compliance structure • How to perform audits on longstanding vs. new business partners • When audits should be done a routine basis vs. only if there is a potential issue • Ensuring that the audit is an independent and documented process • How to evaluate third party compliance with FCPA, and contractual terms and conditions: - examining compliance programs and codes of conduct - books, records and accounts of the third party - third party subsidiaries, joint ventures or affiliates - testing for gifts, travel and entertainment - reviewing expense reports for employees in high-risk positions or countries - examining commission payments and petty cash activity - analyzing the general ledger for high-risk transactions and cash advances PRE-CONFERENCE WORKING GROUPS Tuesday, April 26, 2016 Exclusive Room Rates! American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention the FCPA conference to receive this rate. Continuing Professional Education Credits American Conference Institute (ACI) will apply for Continuing Professional Education credits for all conference attendees who request credit. There are no pre-requisites and advance preparation is not required to attend this conference. Course objective: Update on the FCPA and applicable anticorruption laws and procedures to prevent inappropriate payments. Prerequisite: None. Level of knowledge: Beginner/Intermediate. Teaching Method: Group-Live. Advanced Preparation: None. Delivery method: Group Live. Please refer to the information in this brochure for outline, course content and objectives. Final approval of a course for CPE credits belongs with each states’ regulatory board. Recommended CPE Credit: 14.5 hours for the main conference and an additional 4.0 hours for each workshop. ACI is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN, 37219-2417 or by visiting the web site: www.learningmarket.org To request credit, please check the appropriate box on the Registration form. Continuing Legal Education Credits Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation. ACI certifies that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board. ACI certifies that this activity has been approved for CLE credit by the State Bar of California. You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks after a conference is held. ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request. Questions about CLE credits for your state? Visit our online CLE Help Center at www. americanconference.com/CLE EARN CLE CREDITS
  • 4. Join the Conversation @ACI_Pharma #ACIFCPA ACI Pharmaceuticals/Biotech/Life Sciences Experts DAY ONE Wednesday April 27, 2016 8:30 Opening Remarks from the Co-Chairs Erik Sandstedt Vice President & Assistant General Counsel, Global Investigations Pfizer Inc. (New York, NY) Bret Campbell Partner Cadwalader, Wickersham, & Taft LLP (Washington, DC) 8:45 FCPA COMPLIANCE TOWN HALL: The Latest FCPA Compliance Standards and How to Overcome Program Implementation Challenges Patrick Stokes Senior Deputy Chief, Fraud Section, Criminal Division U.S. Department of Justice (Washington, DC) Charles E. Cain Deputy Chief, FCPA Unit U.S. Securities and Exchange Commission (Washington, DC) Nathaniel Edmonds Partner Paul Hastings LLP (Washington, D.C.) New for 2016, participants will have an enhanced opportunity to ask their questions and engage in discussion with key Government decision-makers. Take this opportunity to gain the latest updates on FCPA compliance expectations and participate in extended Q & A with the key agencies. You are also welcome to submit your questions in advance to FCPA@americanconference.com 10:00 Networking Coffee Break 10:15 DATA TRANSFERS — EU & CHINA Case Studies & Hypothetical Exercises — Determining When and How to Transfer Sensitive Data for R & D, FCPA Compliance and Investigative Purposes Zachary N. Coseglia Assistant General Counsel Global Investigations, China Lead Pfizer (New York, NY) Yaniss Aiche Counsel SheppardMullin (Brussels, Belgium) Kathleen Hamann Partner White & Case LLP (Washington, DC) Through practical scenarios and concrete examples, the esteemed panel will focus on how to manage complex challenges in the EU and China affecting cross-border data transfers. Themes will include: • Meeting U.S. agencies’ expectations for cooperation amid conflicting EU data privacy restrictions • How to properly investigate bribery without committing a criminal act under foreign data privacy laws • Monitoring your compliance program and investigations database to avoid privacy law violations • Special considerations affecting the R & D process and how to address them 11:30 TRENDS IN LIFE SCIENCES FCPA DECLINATIONS AND SETTLEMENTS: Taking Stock of Penalty Trends, Corrective Actions and What Has Triggered a US DOJ Declination James Koukios Partner Morrison & Foerster LLP (Washington, DC) Former Senior Deputy Chief, Fraud Section, Criminal Division, US DOJ Frederic D. Firestone Partner McDermott Will & Emery (Washington, DC) Former Associate Director, Division of Enforcement, SEC • Contrasting US DOJ vs. SEC investigative techniques • What has led to a US DOJ declination vs. an SEC settlement • Recent key cases and what they reveal about evolving government FCPA compliance expectations • New, emerging grounds for enforcement • Increased enforcement of the books and records provisions by the SEC, and priorities going forward • What is expected from your company if your industry is under investigation • How compliance efforts are rewarded 12:30 Networking Luncheon for Attendees & Speakers 1:45 EASTERN EUROPE — How Life Sciences Companies are Tailoring Their Anti-Corruption Compliance Programs to Industry-Specific Risks and Realities on the Ground Mihai G. Popa Country Head of Law, Patents and Compliance Country Group Romania/Bulgaria/Moldova — Law, Patents and Compliance Bayer (Bucharest, Romania) Livia Zamfiropol Partner DLA Piper (Bucharest, Romania) Sandra Bjegovic Regional Compliance Director – Investigations Compliance Division Pfizer Inc. (New York, NY) Bret Campbell — Panel Moderator Partner Cadwalader, Wickersham, & Taft LLP (Washington, DC) • Updates on the legislative, regulatory and enforcement landscapes in the region, including Poland, Hungary, Romania and Bulgaria • Status of the “industry sweep” in Romania • New transparency rules and their impact • Limitations on sponsorship and travel for medical professionals • How to respond to Romanian Government requests for information about interactions with doctors • The varying public procurement processes in each country and best practices for interacting with procurement officials • The realities on the ground: The most significant corruption risk factors in the region and how to minimize them 2:45 ROUNDTABLE DISCUSSION — Third Party FCPA Audit “War Stories” and Lessons Learned: Industry Experts Reveal What They Wish They Knew Then That They Know Now Kristina Ahern Compliance Manager, Auditing & Monitoring Global Compliance Office Hill-Rom (Chicago, IL) Rodrigo Grion Global Head of Monitoring GE Healthcare (Waukesha, WI) At this interactive session, industry experts with extensive third party audit experience will discuss the biggest lessons learned when preparing for and conducting a third party audit. Through anecdotal insights, they will focus on the real-life challenges that they have encountered and how they addressed them. This session is specifically designed to foster audience participation, so please bring your questions! 3:30 Networking Coffee Break 3:45 THE NEW FACE OF ANTI-CORRUPTION COMPLIANCE IN INDIA: Managing the Practical Impact of New Local Regulatory Changes and Rising Whistleblower Allegations Anand Prasad Partner Trilegal (New Delhi, India)
  • 5. Register Now | 888 224 2480 | FCPAconference.com/Pharma a C5 Group Company Business Information in a Global Context Stacey J. Hanna Assistant General Counsel and Director of Global Compliance CAPSUGEL (Morristown, NJ) James W. Haldin Counsel Davis Polk & Wardwell LLP (Washington, DC) • Practical review of Reports No. 254 & 258 of the Law Commission of India • How companies can transform their compliance strategy and prepare for a new legislative landscape • Provisions under the new Companies Act, 2013 which focus on anti-bribery and how to update your compliance programme accordingly • The Lokpal & Lokayukta Act, 2013 and changes made to the Prevention of Corruption Act, 1988 • India’s Whistleblower Protection Act: Best practices for responding to the anonymous whistleblower • How to overcome local challenges to rolling out your program: Balancing cultural norms with global policies and requirements 4:45 FOREIGN GOVERNMENT R & D FUNDING AND REGULATORY APPROVALS: How to Manage Complex FCPA Risks in the Public Procurement and Post-Market Contexts Patricia Gatley Director of Global Compliance NuVasive (San Diego, CA) Brian E. Kowalski Partner Latham & Watkins LLP (Washington, DC) • Understanding which licenses, permits or certifications are legally required in order to identify fabricated requests for payment • What role can/should third parties play to assist in obtaining approvals and what is the liability for third party actions • How to handle requests for donations and political contributions • What role should your government affairs play in vetting requests for political contributions • Responding to and addressing competitor allegations of bribery in the context of a large government contract bidding process • Resolving anti-corruption compliance challenges in local community development projects 5:30 Conference Adjourns DAY TWO Thursday April 28, 2016 8:45 Co-Chairs’ Opening Remarks 9:00 KEYNOTE ADDRESS: Debarment for FCPA and Healthcare Regulatory Violations: Government Speaks on Their Decision-Making Process When Assessing Life Sciences Companies’ Compliance Efforts Douglas Stearn Director Office of Enforcement and Import Operations U.S. Food and Drug Administration (Washington, DC) 9:20 INTERACTING WITH HCPs: Big Picture, Strategic Insights for Ethical Business Conduct, Anti-Corruption and Healthcare Compliance Dennis Barnes Vice President and Chief Compliance Officer PAREXEL International Corporation (Waltham, MA) Gary DiBianco Partner Skadden, Arps, Slate, Meagher & Flom LLP (Washington, DC) At this opening session, the esteemed panelists will provide high level insights on how to dovetail your ethics policies, anti-corruption and regulatory compliance programs for a fully integrated, global strategy for HCP interactions. The discussions will, in part, focus on tailoring your approach to the unique contexts of high risks markets, and will offer concrete examples and lessons learned. 10:15 Networking Coffee Break 10:30 THIRD PARTIES UNDER THE MICROSCOPE: Due Diligence and Monitoring Best Practices Carrie Ann Ashcom Director, Global Compliance Monitoring Zimmer Biomet (Warsaw, IN) Shawn Lichaa Legal Counsel Gilead Sciences (San Francisco, CA) Jacqueline C. Wolff - Panel Moderator Partner Manatt, Phelps & Phillips, LLP (New York, NY) This practical panel will focus on how to manage the evolving risks and approaches to onboarding and monitoring the following types of third parties: • Sales Representatives • Distributors • Law firms and other outside advisors • Agents • Customs Brokers • Lobbyists 11:45 UK BRIBERY ACT AND THE “ADEQUATE PROCEDURES DEFENSE”: What the First Corporate DPA and Recent Cases Reveal about Cooperation and Internal Controls Requirements Matthew Howard Getz International Counsel Debevoise & Plimpton (London, UK) • The ins and outs, and impact of the first corporate DPA, and what it means for enforcement in the UK going forward • New, emerging enforcement risks affecting the life sciences industry • How the SFO has interpreted “cooperation” • Best practices for applying the internal controls, books and records provisions of the UK Bribery Act • What the SFO has required for the “adequate procedures” defense • Justifying your compliance efforts to the SFO: Concrete examples 12:30 Networking Luncheon for Attendees and Speakers 1:30 UPDATES ON CRO COMPLIANCE: The Latest Best Practices for Minimizing Pre- and Post- Market Corruption Risks Keir Strauss Assistant General Counsel, Compliance & Ethics INC Research (Raleigh, NC) Eric Kraeutler Partner Morgan, Lewis & Bockius LLP (Philadelphia, PA) Gary Giampetruzzi Partner Paul Hastings LLP (New York, NY) • Managing evolving bribery risks facing CROs and others in the supply chain • To what extent a sponsor can rely on the CRO’s compliance program vs. conduct due diligence and monitoring • Update on what CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and seeking clinical trial and marketing approvals • Concrete examples of effective CRO policies and anti-corruption compliance programs • Reducing the risk of sponsors’ derivative FCPA liability due to CRO non-compliance
  • 6. Join the Conversation @ACI_Pharma #ACIFCPA ACI Pharmaceuticals/Biotech/Life Sciences Experts © American Conference Institute, 2016 2:30 HYPOTHETICAL EXERCISES — Growing Your Business in China, Brazil and Mexico: Practical Solutions for Managing High Risk Scenarios Affecting Your Operations, Transactions, Clinical Trials and Local Reporting Obligations Marcio Mello Silva Baptista Partner Tozzini Freire Advogados (New York, NY) Tiana Zhang Partner Kirkland & Ellis International LLP (Shanghai, China) David Resnicoff Partner Schiff Hardin LLP (Chicago, IL) Through a review of common transactions that pose significant corruption risks — the use of distributors and promotional interactions with healthcare professionals — the expert speakers will impart best practices and practical tools for minimizing FCPA and anti-corruption risks in China, Brazil and Mexico. In addition, the panelists will highlight risks that are unique to each of these important markets and explain how best to tailor your compliance strategies to each jurisdictional context. 3:30 Networking Coffee Break 3:45 Lessons Learned from EU SUNSHINE REPORTING Statistics and Best Practices Katie C. Pawlitz Partner Reed Smith (Washington, DC) • Update on the EU statistics specific to anti-corruption and what they mean for the life sciences industry • Status of new, pending transparency laws and other transparency mandates in the EU • When will a violation or non-disclosure under the French act result translate into an FCPA or other U.S. legal violation? • Managing the conflicts between Sunshine reporting and data privacy laws With more than 300 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world. As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation. For more information about this program or our global portfolio of events, please contact: Wendy Tyler Director of Sales American Conference Institute Tel: 212-352-3220 x5242 w.tyler@AmericanConference.com TURKEY POLAND IRELAND CHINA UNITED STATES SFA 100 AUS 150 BAR 6 Pharma Law Fir Medical CRO (C Health C 14% 3% 7% 60% 16% Lorem ipsum dolor sit amet, consectetur OPTION ONE Lorem ipsum dolor sit amet, consectetur OPTION TWO Lorem ipsum dolor sit amet, consectetur OPTION THREE TURKEY POLAND IRELAND CHINA UNITED STATES USA 150 CAN 50 FRA 50 BRA 150 SFA 100 AUS 150 CHN 100 BAR 6 CIRCLE Pharmaceutical Companies Law Firm Medical Devices CRO (Contract Research Organizations Health Care Networks/Systems 14% 3% 7% 60% 16% H Eas Delec 90's fund, churc proid De he De he Lorem ipsum dolor sit amet, consectetur OPTION ONE Lorem ipsum dolor sit amet, consectetur OPTION TWO Lorem ipsum dolor sit amet, consectetur OPTION THREE Lorem ipsum dolor sit amet, consectetur OPTION FOUR 100% 100% 100% 100% 100% 100% 100% 100% Global Sponsorship Opportunities 4:30 FCPA AND ECONOMIC SANCTIONS: Leveraging Internal Screening and Healthcare Compliance Resources to Reduce US DOJ, SEC and OFAC Penalty Risks J. Patrick Rowan Partner McGuireWoods (Washington, DC) Danish Hamid Partner Cooley LLP (Washington, DC) • How economic sanctions compliance intersects with healthcare and FCPA compliance • Impact of recent developments in FCPA compliance • Managing overlapping sanctions and FCPA risks posed by distributor and other third party relationships • List management: How to leverage OFAC and other lists for effective screening and re-screening of existing and new business partners • When an FCPA investigation can trigger economic sanctions enforcement, and vice versa 5:15 Conference Concludes Here’s who you can expect to network, benchmark and learn from this April’s FCPA & Anti-Corruption for the Life Sciences Industry event: AUDIENCE PROFILE Meet with a Global Audience. Over the last 4 years, delegates from 5 countries have attended ACI’s FCPA & Anti-Corruption for the Life Sciences Industry event:
  • 7. a C5 Group Company Business Information in a Global Context o I would like to receive CLE accreditation for the following states: . See CLE details inside. o I would like to receive CPE accreditation for the following states: . See CPE details inside. Complete Payment Details4 Bringing a Team? 3 - 4 10% Conference Discount 5 - 6 15% Conference Discount 7 20% Conference Discount 7 or more Call 888-224-2480 Payment Policy Payment must be received in full by the program date to ensure admittance. All discounts will be applied to the Program Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to 3 or more individuals employed by the same organization, who register at the same time. Delegate Substitutions and Cancellations Youmustnotifyusbyemailatleast48hrsinadvanceoftheconference if you wish to send a substitute participant. If you are unable to find a substitute, please notify us in writing no later than 10 days prior to the conference date. All cancellations received will be subject to a cancellation fee of $350. Delegates opting to receive a credit voucher will receive a credit for the full amount paid, redeemable against any other American Conference Institute conference in the next 12 months. No credits or refunds will be given for cancellations received within 10 days of the conference start date. Delegates may not “share” a pass between multiple attendees without prior authorization. No liability is assumed by American Conference Institute for changes in program date, content, speakers or venue. American Conference Institute reserves the right to cancel any conference it deems necessary and will,in such event,make a full refund of any registration fee,but will not be responsible for airfare, hotel or other costs incurred by registrants. Terms and Conditions Fill in your Profile SALUTATION NAME JOB TITLE ORGANIZATION ADDRESS CITY STATE/PROVINCE ZIP CODE COUNTRY TEL. FAX EMAIL TYPE OF BUSINESS NO. OF EMPLOYEES APPROVING MANAGER JOB TITLE 3 Select your Level of Engagement SAVE $100 Register & Pay by March 25, 2016 Register & Pay after March 25, 2016 o Conference $2095 $2195 o Conference + 1 Workshop o A or o B $2695 $2795 o ELITEPASS*: Conference + Both Workshops $3195 $3295 All program participants will receive an online link to access the conference materials as part of their registration fee. o Please reserve ___ additional copies of the Conference Materials at $199 per copy. 2 *ELITEPASS is recommended for maximum learning and networking value. 5 Accept the Terms and Conditions to Register I confirm I have read and understood the terms and conditions of registering for this event 895L16-NYCConference Code 1 PHONE: 1-888-224-2480 EMAIL: CustomerService@AmericanConference.com   MAIL: American Conference Institute 45 West 25th Street, 11th Floor New York, NY 10010 ONLINE: FCPAconference.com/Pharma FAX: 1-877-927-1563   Choose your Registration Method Fee Includes The program, all program materials, refreshment breaks and lunches. Please charge my o VISA o MasterCard o AMEX o Discover Card o Please invoice me NUMBER EXP. DATE CARDHOLDER o I have enclosed my cheque for $_______________ _including applicable taxes made payable to American Conference Institute (T.I.N.—98-0116207) o ACH PAYMENT ($USD) Please quote the name of the attendee(s) and the event code 895L16 as a reference. For US registrants: Bank Name: HSBC USA Address: 800 6th Avenue, New York, NY 10001 Account Name: American Conference Institute UPIC Routing and Transit Number: 021-05205-3 UPIC Account Number: 74952405 Non-US residents please contact Customer Service for Wire Payment information Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. Venue Information at a Glance Venue: Park Lane Hotel Address: 36 Central Park South, New York, NY 10036 TEL.: 800-221-4982 Online: tinyurl.com/FCPAPharma16 Book your Accommodation American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention the “ACI’s FCPA Life Sciences” conference to receive this rate. If you missed the chance to attend an ACI event, you can still benefit from the conference presentation materials. To order the Conference Materials, please call +1-888-224-2480 or visit: www.americanconference.com/ conference_papers MISSED A CONFERENCE? ORDER THE CONFERENCE MATERIALS NOW! Anti-Corruption Compliance in High Risk Markets July 2016 WASHINGTON,DC MARK YOUR CALENDAR FOR THE FOLLOWING ACI ANTI-CORRUPTION EVENTS: Annual Conference on the Foreign Corrupt Practices Act May 16-17, 2016 NEWYORK Brazil Summit on Anti-Corruption May 24-25, 2016 SAO PAULO to register for these events and more, visit AntiCorruptionConferences.com
  • 8. April 27–28, 2016 | Park Lane Hotel | New York, NY April 27–28, 2016 Park Lane Hotel | New York, NY American Conference Institute’s 10th Advanced Forum on FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY American Conference Institute’s 10th Advanced Forum on FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY 895L16.E REGISTRATION CODE  Attention Mailroom If undeliverable to addressee, please forward to: Partner, Senior Counsel, Corporate Counsel , Director, Compliance Officer, Director of Ethics and Compliance, Director Internal Audit Incorrect Mailing Information If you would like us to change any of your details, please email data@americanconference.com or fax the label on this brochure to 1-877-927-1563. American Conference Institute 45 West 25th Street, 11th Floor New York, NY 10010 This year marks 30 years since the inception of C5 Group. It is time to match our brand with the dynamic strides we have made. See inside for details… ACIAmerican Conference Institute Business Information in a Global Context EARN CLE/CPE CREDITS