8th Advanced Forum on
FCPA & Anti-Corruption
for the Life
Sciences Industry
April 28-29, 2014 • DoubleTree Suites by Hilton Times Square • New York, NY
Network and Benchmark with Life Sciences
Experts from the U.S., China, Brazi, India,
Russia and the UK, Including:
John de Grandpre
Senior Vice President & General Counsel, Capsugel
Steven Sokolow
Vice President & General Counsel , Novartis Services
Richard Rew
SVP & General Counsel, ArthroCare Corporation
Eve Costopoulos
VP and Chief Ethics and Compliance Officer, Eisai
Sujata Dayal
Vice President Health Care Compliance and
Privacy, Pharmaceuticals, Johnson & Johnson
David Walters
Division Counsel, Abbott Laboratories
Brent White
Vice President, Internal Audit, Allergan
David King
Counsel, Merck
Dr. Dipti Amin
Senior Vice President & Chief Compliance Officer
Quintiles (UK)
Matthew L. Stennes
Senior Counsel, Global Investigations, Medtronic
Stephanie Meltzer
Vice President, Assistant General Counsel, Pfizer
Ela Bochenek
VP & Associate General Counsel International
NPS Pharmaceuticals
Daniel Garen
SVP & Chief Compliance Officer
Wright Medical Technology
Ilana Shulman
Associate General Counsel, Latin America,
Legal and Compliance, Astellas US
Louis Ramos
Lead Compliance Counsel for Latin America,
International R & D and Manufacturing, Pfizer
Be a part of the one annual anti-corruption event that consistently attracts the
“who’s who” of the Life Sciences industry—all in one room. New for 2014, the agenda
has been completely updated, including more focus on global anti-corruption
compliance and liability risks:
 SPECIAL FOCUS ON CHINA:
• Using Chinese Travel Agencies in the Wake of GSK: How to Tailor Your
Outsourcing, Selection and Monitoring Practices in Response to Heightened
Corruption and Bribery Enforcement Risks
• How to Update Your Corporate and Individual Risk Profile Amid the Explosion
of PSB and SAIC Commercial Bribery Investigations: How PSB and SAIC are
Enforcing Chinese Commercial Bribery Laws
• CHINA COMPLIANCE STRATEGY SESSION: How Life Sciences Companies Have
Adapted Their Management, Distribution, Sales, Marketing and Employee
Training Policies to the Chinese Context
 CASE STUDIES ON BRAZIL, RUSSIA AND INDIA: Practical Solutions for Managing
High Risk Scenarios Affecting Your Operations, Transactions, Clinical Trials and
Local Reporting Obligations
 Best Practices for Structuring and Monitoring Your Distributor and Sub-Distributor
Relationships in High Risk Markets
 LEGAL EXECUTIVE PANEL: How Recent Developments Have Impacted Life Sciences
Companies’ Legal Risk Appetites, Use of Outside Advisors and Approach to
Reputational Risk Management
 More Discussion on How to Leverage the Audit and Accounting Functions to Better
Identify Risk:
• How to Detect and Monitor Corruption in Your Operations: Ensuring Your
Internal Audit Function, Data Analytics and Metrics Are in Line with
Your Business Model and Risk Profile
Lee Lowder
Director, Global Compliance, K2M
• Do’s and Don’ts for Auditing CRO Anti-Corruption Compliance
Joshua Torok
Associate Director, Internal Audit, PPD
Lead Sponsor:
Earn
CLE/CPE
Credits
Supporting Sponsor:
Sue Seferian
Health Care Compliance Officer, Johnson & Johnson
Register Now • 888-224-2480 • www.FCPAConference.com/Pharma
Earn
TASA
Credits
Gsk executives detained in china. More fcpa penalties against life sciences
companies. With heightened anti-corruption enforcement in the U.S.,
China and across the globe, life sciences companies are facing
increasingly unique, big ticket compliance challenges.
be a part of the one annual anti-corruption event that is specifically tailored to your industry.
I
n response to the unique challenges facing biopharmaceutical and
medical device companies in this daunting enforcement climate,
the 8th National Conference on FCPA & Anti-Corruption for the Life
Sciences Industry provides a forum for the key players – preeminent
corporate counsel, and leading FCPA practitioners – to come together
for critical networking and benchmarking on how to combat the next
wave of FCPA allegations.
 The agenda provides more focus on foreign anti-corruption
U.S. and foreign prosecutors are using all the tools at their disposal
to ensure that FCPA and anti-corruption violations by medical
device, biotech and pharmaceutical companies are brought to
light and punished. Do not miss your chance to be part of the most
comprehensive, industry-tailored forum on innovative solutions for
protecting your company before, during, and after the government
comes knocking.
specific sessions on vetting and monitoring third parties,
including distributors, travel agencies, and lower tier supply
chain parties
New for 2014, the program has evolved to include an enhanced focus
on how to overcome global risk management challenges, and how to
tailor your anti-corruption compliance to the unique context of each
foreign jurisdiction. New features for the 2014 program include:
 As the GSK matter continues to unfold, the program includes
a more practical discussion of how to re-assess China-specific
risk areas, including requirements under local commercial
bribery laws, how to reduce unique risk factors impacting
your local operations and employees, manage a local
government investigation, and minimize both individual
and corporate liability risks
laws and regulations, including case studies on high risk
scenarios in Brazil, India and Russia. There will also be an
enhanced focus on how to incorporate both FCPA and foreign
requirements into your compliance program, and tailor your
approach to the particularities of a given jurisdiction
 In response to many requests, the agenda will feature more
 Benefit from a new case study on “Controlling Bribery Risks
When Interacting with Influential Local Decision-Makers:
Risk Management Strategies for Obtaining Market Access
Rights, Pricing and Other Regulatory Approvals”
 More practical discussions on leveraging the audit and
accounting function to better identify risk:
• INTERNAL AUDITS – How to Detect Corruption in Your
Operations: Ensuring Your Internal Audit Function, Data
Analytics and Metrics Are in Line with Your Business
Model and Risk Profile
• CRO AUDIT CASE STUDY – How to Audit Anti-Corruption
Compliance for CROs: Best Practices for Maximizing Your
Audit Function to Better Detect Risk
Do not miss your chance to be part of the most comprehensive, industry-tailored forum on global anti-corruption compliance and enforcement.
Register today by calling 888-224-2480, fax your registration form to 877-927-1563, or online at FCPAConference.com/Pharma.
Continuing Legal Education Credits
CLE
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 in the amount of 16.5 hours. An
additional 4.0 credit hours will apply to Workshop A/B participation.
ACI certifies that this activity has been approved for CLE credit by the State
Bar of California in the amount of 13.75 hours. An additional 3.5 credit hours
will apply to Workshop A/B participation.
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
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 anti-corruption
laws and procedures to prevent inappropriate payments. Recommended CPE Credit:
16.5 hours. An additional 4.0 credit hours will apply to Workshop A/B participation.
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.nasba.org
To request credit, please check the appropriate box on the Registration form.
TASA Approved Training
ACI certifies that this activity has been approved for TASA course credit in the
amount of 6.0 credit hours (3 per day). An additional 2.0 credits will apply to
working group A and B participation.
TASA candidates are required to complete the appropriate TASA forms during the conference.
TASA credits are processed in 1-3 weeks after a conference is held.
TRACE Anti-Bribery Specialist Accreditation (TASA) is a comprehensive training and
certification program focused on anti-bribery compliance. To learn more about accreditation,
please visit www.thetasa.org or contact Virna Di Palma at dipalma@traceinternational.org.
Register now: 888-224-2480 • Fax: 877-927-1563 • www.FCPAConference.com/Pharma
Day 1
8:30
Opening Remarks from the Conference Co-Chairs
Monday, April 28, 2014
David Walters
Division Counsel
Abbott Laboratories (Abbott Park, IL)
SPECIAL FOCUS ON CHINA
10:15
Amy L. Sommers
Partner
K & L Gates LLP (Shanghai, China)
Asheesh Goel
Partner
Ropes & Gray LLP (Chicago, IL)
8:45
Jay Holtmeier
Partner
WilmerHale (Washington, DC)
DOJ AND SEC ALUMNI ROUNDTABLE
DISCUSSION: Former FCPA Prosecutors Discuss
the Life Sciences Sweep, USDOJ and SEC Compliance
and Internal Controls Expectations, and the Potential
for Commercial Bribery Enforcement
Nathaniel Edmonds
Partner
Paul Hastings LLP (Washington, DC)
Former Assistant Chief, FCPA Unit, Fraud Section,
Criminal Division, USDOJ
Steven E. Fagell
Partner
Covington & Burling LLP (Washington, DC)
Former Deputy Chief of Staff and Counselor,
Criminal Division, USDOJ
Frederic D. Firestone
Partner
McDermott Will & Emery (Washington, DC)
Former Associate Director, Division of Enforcement, SEC
Hank Bond Walther
Partner
Jones Day LLP (Washington, DC)
Former Deputy Chief, FCPA Unit, Fraud Section, Criminal
Division, USDOJ
William Stuckwisch – Panel Moderator
Partner
Kirkland & Ellis LLP (Washington, DC)
Former Assistant Chief, Fraud Section, FCPA Unit, USDOJ
At this in-depth session, learn how to meet unique, new risks
factors posed by travel agencies in China. The discussion will
focus on:
• Real-life approaches to reducing individual and corporate
exposure post-GSK
• What life sciences companies have recently done to minimize
both FCPA and Chinese Government enforcement risks
• When to refrain from outsourcing travel services in China
• Pros and cons of managing employee travel internally
11:15 Yuet Ming Tham
Partner
Sidley Austin LLP (Hong Kong)
• Understanding how the PRC’s commercial bribery laws are
being enforced, and how local prosecutors are investigating
foreign companies and their executives
• What to do in the event of employee detentions
• Managing a Chinese Government inquiry/investigation
• Knowing the definitions of “foreign official” and
“instrumentality” in the Chinese landscape
• What documents and evidence you should prepare when SAIC
or Chinese Police visit your company
• How to brief senior company officials before interviews
with SAIC officials
• How to decrease the fine and show your commitment
to compliance: Restructuring, training, company policy
adjustment, monitoring solutions
• The role of outside lawyers and advisors
• What does it mean to “cooperate” in the Chinese landscape
• What is the best strategy for negotiation with China Authority
• How much to disclose on the investigation findings to
shareholders and the public
•Stryker
• Eli Lilly
• Pfizer
• Biomet
• Orthofix
• Smith & Nephew
• Johnson & Johnson
Networking Coffee Break
Updating Your Corporate and Individual Risk Profile
Amid the Explosion of PSB and SAIC Commercial
Bribery Investigations: Practical Review of Chinese
Anti-Bribery Laws, and New Local Enforcement
Risks for CROs, Pharmaceutical, Medical Device and
Biotechnology Companies
Richard Rew
Senior Vice President & General Counsel
ArthroCare Corporation (Austin, TX)
This unique panel will bring together former USDoJ and SEC
officials, who have worked on some of the most recent, high
profile FCPA cases during their tenure in government. The expert
panel will provide you with a practical discussion of recent key
cases and what they reveal about evolving government FCPA
compliance expectations. The esteemed panelists will also
explore new, emerging grounds for enforcement, including the
possibility of commercial bribery enforcement by the SEC. Topics
will include lessons learned from key, recent noteworthy life
sciences cases, including:
10:00
Using Chinese Travel Agencies in the Wake of GSK:
Tailoring Your Outsourcing, Selection and Monitoring
Practices in Response to Heightened Enforcement Risks
12:15
Networking Luncheon
Register now: 888-224-2480 • Fax: 877-927-1563 • www.FCPAConference.com/Pharma
1:30
CHINA COMPLIANCE STRATEGY SESSION –
Refining Your Anti-Corruption Compliance and
Operational Strategy for China: How Life Sciences
Companies Have Adapted Their Management,
Distribution, Sales, Marketing and Employee Training
Policies to the Local Context
Brent White
Vice President, Internal Audit
Allergan (Irvine, CA)
Joshua Torok
Associate Director, Internal Audit
PPD, LLC (Wilmington, NC)
Cathy LeBlanc
Senior Manager
Deloitte Financial Advisory Services LLP (Boston, MA)
Sujata Dayal
Vice President Health Care Compliance and Privacy,
Pharmaceuticals
Johnson & Johnson (Chicago, IL)
Michael Li-Ming Wong
Partner
Gibson Dunn (San Francisco, CA)
• How to closely align compliance programs with Chinese
cultures, languages, business practices and regulations
• How to select and screen local parties – principal investigators,
HCPs, CROs, doctors
• Conducting an effective risk assessment – which departments
should be included/exclude
• Reviewing local industry codes, interactions with HCPs, gifts,
charitable contributions, sponsorships, grants, meals and
entertainment and fee-for-service arrangements in China
• Assessing the level of interaction with public officials, and the
extent of business with government affiliated entities
• Re-evaluating the use of third party intermediaries
• Types of documentation to review/create during the risk
assessment process
• What can you reasonably do to mitigate risks that are unique
to China?
- criteria for selection of international business representatives
- procedures for vetting, monitoring and re-qualifying
- training of company sales and marketing personnel
- establishing review thresholds as the size and/or percentage
of proposed commissions grows
2:30
• Selecting an independent corporate compliance monitor
• How to interact and work effectively with independent
corporate compliance monitors: Structuring the relationship,
establishing the work plan and projected costs
• How a third party monitor assesses a company’s compliance status
• Establishing a framework and approach within your Internal
Audit Department
- Assessing the risk of each operating unit to decide where
audit efforts should be focused
- Understanding the common vehicles and schemes used in
the life sciences context
- Building audit steps within the confines and contexts of the
life sciences industry to appropriately mitigate the risk of
the most common schemes
- Interviewing vs. testing of transactions
- In-person and paper audits
• Analytics:
- How analytics for detecting bribery and corruption schemes
differ from those used to identify traditional financial and
accounting fraud
- Incorporating targeted, model-based mining and visual
analytics tools to identify unusual patterns
4:45
LEGAL EXECUTIVE PANEL – The Increase in
Global Anti-Corruption Enforcement: How Recent
Developments Have Impacted Life Science Companies’
Legal Risk Appetites, Use of Outside Advisors and
Approach to Reputational Risk Management
Steven S. Michaels
Counsel
Debevoise & Plimpton LLP (New York, NY)
Eric W. Siturchuk
Partner
Morgan, Lewis & Bockius LLP (Philadelphia, PA)
John de Grandpre
Senior Vice President & General Counsel
Capsugel (Morristown, NJ)
Eve Costopoulos
Vice President and Chief Ethics and Compliance Officer
Eisai Inc. (Woodcliff Lake, NJ)
Douglas N. Greenburg
Partner
Latham & Watkins LLP (Washington, DC)
• Case studies: Which activities during recent clinical trials have
raised red flags to enforcement authorities?
• Managing risk when making payments to principal
investigators, other healthcare professionals (HCPs),
or consultants in connection with a clinical trial
- Transparency of payments in clinical trial contracting:
best practices in budget drafting
- Determining fair market value of the payments made to HCPs
- Compliance with local anti-corruption laws and sector
specific guidance
• Providing equipment for use during a trial
- Legal and ethical concerns regarding “donated equipment”
- Protocols for leasing equipment
- Options for handling equipment following trial completion
• Risk management with respect to CROs involved in investigator
retention and payment
- Ensuring that all payments are disclosed to and approved
by sponsor
- Ensuring proper training of CRO / consultant staff regarding
FCPA and anti-corruption law
- Best practices in CRO contract drafting
At this exclusive session, attendees will have the unique
opportunity to hear from in-house legal executives tasked with
overseeing their organizations’ complete legal risk management
strategy. Gain first-hand insights on the impact of the GSK
matter and other significant developments on their approach to
weathering enforcement risks and deciding whether or not to
retain outside advisors.
3:30
Networking Refreshment Break
3:45
Detecting and Monitoring Corruption Across Your
Operations: First-Hand Insights on How to Work
With Compliance Monitors, and Leverage Your
Internal Audit Function, Data Analytics and Metrics
Daniel Garen
SVP & Chief Compliance Officer
Wright Medical Technology, Inc. (Arlington, TN)
CLINICAL TRIAL YEAR IN REVIEW –
The Top 10 Clinical Trial Mistakes That Can Lead to
an FCPA Enforcement Action: Practical Lessons for
Conducting International Trials in High Risk Markets
5:30
Conference Adjourns
Register now: 888-224-2480 • Fax: 877-927-1563 • www.FCPAConference.com/Pharma
Day 2
Tuesday, April 29, 2014
8:30
Opening Remarks from the Co-Chairs
8:35
Structuring and Monitoring Your Distributor and
Sub-Distributor Relationships in High Risk Markets:
How to Overcome Complex Legal and Compliance
Challenges Affecting Your Supply Chain Management
and Bottom Line
David King
Counsel
Merck (New York, NY)
Peter Spivack
Partner
Hogan Lovells (Washington, DC)
• Acting on negative findings — how to establish cause to
terminate or unwind a distributor agreement
• Guidance on how life sciences companies should conduct
due diligence and act on findings when there are reasonable
suspicions of corrupt acts, but no actual convictions or other
official findings of wrongdoing
• Deciding whether to turn evidence over to local authorities
when corrupt behavior is detected
• How can foreign importers determine if their local distributors are
actually corrupt or simply the victims of black PR
• How to determine if your distributors use sub-agents, and how
far down the line must you investigate
• Understanding the legal implications surrounding liability for
behavior of parties with whom you have no contract
Brazil
• Brazil’s new anti-corruption law – “Lei Anticorrupção” – and
its application to life sciences companies
• Facilitating payments and customs transactions
• Sponsorship of sporting events
Russia
• The application of Russia’s new anti-bribery law to global life
sciences companies
• Article 13.3 requirements, including the requirement to have
compliance personnel and a clear mechanism for internal
investigations
• Vetting and monitoring distributors in Russia post-Novo Nordisk
India
• Drug registration and marketing approvals
• Clinical trials and investigators
11:00 Networking Coffee Break
11:15
Top 10 Mistakes by Life Sciences Companies
When Conducting Internal Investigations:
Investigative Approach, Evidence Preservation,
Voluntary Disclosure and Other Pitfalls
Matthew L. Stennes
Senior Counsel, Global Investigations
Medtronic, Inc. (Minneapolis, MN)
Angela T. Burgess
Partner
David Polk & Wardwell LLP (New York, NY)
Kevin Corbett
Partner
Deloitte Financial Advisory Services LLP (New York, NY)
FOCUS ON BRAZIL, RUSSIA AND INDIA
9:30
During this interactive session, you will benefit from a comprehensive
discussion of best practices for conducting an internal FCPA
investigation. Learn about the most overlooked mistakes, what
actions must be taken immediately upon discovering wrongdoing,
and how information discovered during an internal investigation
can be used to minimize prosecution risks and maximize credibility
to the Government. Please come prepared with questions as ample
time will be provided for Q&A as well.
CASE STUDIES – Growing Your Business in Brazil,
Russia and India: Practical Solutions for Managing High
Risk Scenarios Affecting Your Operations, Transactions,
Clinical Trials and Local Reporting Obligations
Esther Miriam Flesch
Partner
Trench, Rossi e Watanabe São Paulo (São Paulo, Brazil)
Louis Ramos
Lead Compliance Counsel for Latin America,
International R & D and Manufacturing
Pfizer Inc. (Washington, DC)
Percy Bilimoria
Senior Partner
AZB & Partners (Mumbai, India)
Dmitry Kurochkin
Partner
Dechert LLP (Moscow, Russia)
Bret A. Campbell – Panel Moderator
Partner
Cadwalader, Wickersham, & Taft LLP (Washington, DC)
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 Brazil, Russia, and India.
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. This
discussion of market-specific risks will include:
12:15
Networking Luncheon
1:30
CRO AUDIT CASE STUDY – How to Audit Your
CROs’ Anti-Corruption Compliance
Dr. Dipti Amin
Senior Vice President & Chief Compliance Officer
Quintiles (Reading, UK)
Sue Seferian
Health Care Compliance Officer
Johnson & Johnson (Titusville, NJ)
At this unique session, learn how Johnson & Johnson and Quintiles
have partnered to ensure ongoing compliance through effective
auditing. The expert speakers will take you through their approach
to detecting compliance weaknesses and implementing corrective
action before it’s too late. Topics will include:
• How to structure the audit team
• Scope of the audit
• How to update your internal audit approach in response
to recent enforcement actions
• How to identify potential issues and address them
• Working together to strengthen anti-corruption compliance
• Contractual protections to incorporate for a partnership
Register now: 888-224-2480 • Fax: 877-927-1563 • www.FCPAConference.com/Pharma
2:15
Tailoring Your Global Anti-Corruption Compliance
Program to the Realities of Different Jurisdictions: Life
Science-Specific Strategies for Incorporating FCPA and
Local Anti-Corruption Requirements
• 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
Stephanie Meltzer
Vice President, Assistant General Counsel
Pfizer Inc. (New York, NY)
Ilana Shulman
Associate General Counsel, Latin America,
Legal and Compliance
Astellas US LLC (Northbrook, IL)
At this worthwhile benchmarking session, hear from leading
international compliance experts on their approaches to ensuring
global FCPA compliance, and adherence to foreign anti-corruption
laws and regulations. Benefit from an interactive discussion
on how to re-evaluate your compliance strategy, tighten your
organization’s anti-corruption compliance program and maximize
its effectiveness within each local foreign context.
4:45
Pravin B. Rao
Partner
Perkins Coie (Chicago, Il)
Ample time will be left for Q & A, so please bring your questions!
3:15
Networking Refreshment Break
3:30
CASE STUDY – MARKETING, RESEARCH & CME
ACTIVITY: How to Implement Effective Internal
Controls to Minimize FCPA Exposure
• How US and foreign prosecutors are using data collected under
Sunshine for FCPA and anti-bribery investigations
- To what extent will Sunshine increase corruption
enforcement as HCP spend disclosures expand globally
• Conducting risk assessment from the data disclosed: Spotting
the red flags in your own data which the government will look
at when determining potential FCPA violations
- Which mechanisms should companies have in place to
demonstrate a payment is not a kickback to an HCP or a
government official?
- Clearly documenting all payments
• Clarifying reporting obligations under federal Sunshine laws for
foreign affiliates: Determining what type of info to capture and
how to report on it
- Reporting by foreign parent companies for payments made
within the U.S.
- Reporting by U.S. based companies for payments made
outside the U.S.
• Update on the status of France’s transparency law and other
new transparency mandates internationally
- When will a violation or non-disclosure under the French act
translate into an FCPA violation?
• How do data privacy considerations figure in?
Ela Bochenek
Vice President & Associate General Counsel International
NPS Pharmaceuticals (Bedminster, NJ)
Lee Lowder
Director, Global Compliance
K2M Inc. (Leesburg, VA)
• Best practices for organizing medical conferences, travel
arrangements, physician sponsorships, advisory boards, and
entertainment
• Grants – creating a mechanism to monitor how grants funds
are spent
• Speaker programs, KOLs and thought leaders and their use in
a promotions strategy
• Crafting permissible guidelines for the use and compensation
of consultants and advisory boards
• Utilizing an objective process to bestow physician benefits
• Navigating the blurry line between providing free equipment
for trials and tests in a way that will not be viewed as a payment
• Determining who the recipient of the free equipment really is
• Government official or person with approval authority over the
sale of the drug or device
4:15
Controlling Bribery Risks When Interacting with
Influential Local Decision-Makers: Risk Management
Strategies for Obtaining Market Access Rights, Pricing
and Other Regulatory Approvals
Asheesh Goel
Partner
Ropes & Gray LLP (Chicago, IL)
This highly practical session will discuss how to overcome
critical corruption risk factors that arise when trying to obtain
foreign regulatory approvals and grow your business in high risk
markets. Through a review of real-life and hypothetical scenarios,
you will take away best practices for fine tuning your approach
to interacting with local government decision-makers while
maintaining FCPA compliance.
SUNSHINE ACT – The U.S. and French Sunshine
Acts, and the Potential for More Anti-Corruption
Investigations: How Life Sciences Companies Have
Updated Their Risk Mitigation Strategies
5:15
Conference Concludes
Global Sponsorship Opportunities
With more than 500 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, Head of Sales, American Conference Institute
Tel: 212-352-3220 x5242 | w.tyler@AmericanConference.com
Register now: 888-224-2480 • Fax: 877-927-1563 • www.FCPAConference.com/Pharma
Post-Conference Working Groups • Wednesday, April 30, 2014
9:00 a.m. – 12:30 p.m. (Registration Opens at 8:30 a.m.)
A
The Ins and Outs of Ensuring Third Party Compliance
and Auditing: When and How to Vet, Monitor and
Terminate Key Relationships
1:30 p.m. – 5:00 p.m. (Registration Opens at 1:00 p.m.)
B
Gifts, Rebates, Entertainment and Hospitality in
High Risk Markets: A Complete Guide to Creating
and Updating Your Policies
James T. Parkinson
Partner
BuckleySander LLP (Washington, DC)
Steven Sokolow
Vice President & General Counsel
Novartis Services, Inc. (New York, NY)
James G. Tillen
Member
Miller & Chevalier Chartered (Washington, DC)
Eric H. Sussman
Partner
Kaye Scholer LLP (Chicago, IL)
During this interactive and practical working group, the session
leaders will guide you through a deep-dive discussion of how to
implement effective third party compliance and auditing practices
for life sciences operations, particularly within high risk markets.
Walk away from this session with concrete tools, best practices and
practical tips for ensuring that your company has proper internal
controls in place to prevent corruptive behavior by your foreign
HCPs, doctors, consultants and other third parties. The workshop
will include a hands-on demonstration of how to create a robust
third-party management and auditing program with minimal
administrative and financial burden.
This interactive and practical working session will go beyond
high-level understanding of the FCPA to identify concrete tools
and tactics for avoiding the loopholes presented by the cultural
expectations of gift giving, entertainment and hospitality in high
risk markets. Attendees will receive practical guidance on how
to create a robust, culturally sensitive, and cost-effective and
credible approach to gifts, travel and entertainment. Attendees
will also learn about risk factors, weighting, and legally obtainable
information that will ensure consistency throughout their
organizations.
Topics of discussion during this session will include practical
guidance on:
• Monitoring actions undertaken by CROs, consultants and agents
when seeking health ministry approval of clinical trial activity
• Requiring third parties to certify knowledge and compliance
with FCPA and applicable anti-corruption laws, including the UK
anti-bribery statute
• Knowing where to draw the line with foreign third parties
regarding what does/does not qualifyas a facilitation payment
- overcoming cultural attitude and local customs that facilitate
“grease payments”
• Detecting wrongdoing – how to setup effective red and green
flags throughout the relationship auditing process
• Installing and maintaining effective policies and procedures
for monitoring activities of foreign subsidiaries, agents,
distributors, resellers and suppliers
• Practical strategies for monitoring and auditing compliance by
various parties with the terms of your agreement
• Understanding local restrictions and what gifts may be acceptable
• How to handle cash payment requests, unreasonable
compensation and flat fees
• How to balance the need for internal controls with the
expectations of customers in their target markets
• Knowing what facilitating payments are acceptable, and what
is not
• Managing the expectations of local government officials
• Hospitality: managing the “reasonable and customary”
standard across multiple jurisdictions
• Involuntary payments: when intentions are good, but controls
are weak
• Contractually-mandated hospitality: how do you handle
it and what is reasonable?
© American Conference Institute, 2014
Who You Will Meet
Pharmaceutical, Biotech, CRO and Medical Device Professionals Responsible for:
- Legal & Regulatory Affairs and Enforcement
- FCPA and Anti-Corruption
- Internal Audits and Investigations
- International Trade and Regulation
- Ethics and Compliance
- Global Compliance and Training
Law Firm Counsel Practicing in:
- FCPA and Anti-Corruption
- Government Investigations
- White Collar Crime
- International Trade and Regulation
Media and Association Partners:
- Life Sciences
- Forensic Accountants
- Due Diligence and Investigations Executives
Register now: 888-224-2480 • Fax: 877-927-1563 • www.FCPAConference.com/Pharma
8th Advanced Forum on
FCPA & Anti-Corruption
for the Life
Sciences Industry
April 28-29, 2014 • DoubleTree Suites by Hilton Times Square • New York, NY
R E g i s t r at i o n f o r m
Network and Benchmark with a
New 2014 Faculty of Industry Experts:
Merck
Quintiles
Novartis
Medtronic
Johnson & Johnson
Allergan
Eisai
ArthroCare
Astellas US
Capsugel
NPS
Pharmaceuticals
Pfizer
PPD
Registration Fee
The fee includes the conference‚ all program materials‚ continental breakfasts‚
lunches and refreshments.
PRIORITY SERVICE CODE
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829L14.S
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available to individuals employed by the same organization.
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a substitute participant. Delegates may not “share” a pass between multiple
attendees without prior authorization. If you are unable to find a substitute,
please notify American Conference Institute (ACI) in writing up to 10 days
prior to the conference date and a credit voucher valid for 1 year will be issued
to you for the full amount paid, redeemable against any other ACI conference. If
you prefer, you may request a refund of fees paid less a 25% service charge. No
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Hotel Information
Conference Code: 829L14-NYC
o YES! Please register the following delegate for FCPA & Anti-Corruption for the Life Sciences Industry
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 for Life Sciences Industry” conference to receive this rate.
Hotel:
Doubletree Suites by Hilton Times Square
Address:
1568 Broadway, New York, NY 10036
Telephone:212-719-1600
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