Register for Latin American Pharma Compliance Congress
1. Register Now | +1 212 352 3220 Ext. 5482 | L.Alexandre@AmericanConference.com
Third Latin American
Pharmaceutical and Medical Device
Compliance Congress
August 23 – 25, 2016 | Hilton Panama, Panama City
ACIAmerican Conference Institute
Business Information in a Global Context
Spanish-English Simultaneous Translation
Available During the Event!
La Conferencia se llevará a cabo en Español
e Inglés con Traducción Simultánea!
EARN CLE/CPE
CREDITS
The 2016 Congress Features Exclusive, Forward-Thinking Panels
and Speakers, including:
LATAM CEOs Discuss Compliance Priorities and the Role Ethics Plays in the Reputation
of the Healthcare Industry
LATAM Marketing Director and Compliance Officer Roundtable: How to Effectively
Balance Sales and Compliance Objectives
The Structure of Global Ethics: Interview with Senior CCOs from US and Europe
Building Relationships while Maintaining Compliance: Practical Discussion on the
Do’s and Don’ts of Interacting with HCPs in Latin America
50+ Leading Industry Speakers from Latin America, the USA and Europe
PLUS:
Do Not Miss the Launch of Transparency International’s Anti-Corruption Principles for
the Latin American Pharmaceutical Industry
Customize Your Program with Targeted Breakout Sessions: Compliance Think Tanks,
Executive Roundtables, Regional Updates, and Practical Scenarios
Take Part in Exclusive Working Groups: Special Focus on Anti-Bribery and Sponsorships
Congress Co-Chairs:
Imelda Alvarez
Novartis
Andrés Cedrón
Stryker Corporation
Karla Guillen
Johnson & Johnson
ASSOCIATION PARTNERS:
SPONSORED BY:
Benchmark Compliance
Programs with:
• Abbott
Laboratories
• Bayer
• Bristol Myers
Squibb
• Genomma Lab
• Horizon Pharma
• Johnson &
Johnson
• Medtronic
• Merck
• Novartis
• Quintiles
• Sandoz
• Sanofi-Aventis
• Smith & Nephew
• Stryker
• Takeda Pharma
• Zimmer Biomet
2. Join the Conversation @ACI_Pharma #LATAMcongress ACI: Pharmaceuticals/Biotech/Medical Device2
With increasing transparency expectations and rising
Government enforcement activity across LATAM, this Congress
and the sharing of industry’s best practices have never been
timelier. Now is the time to upgrade your compliance program.
With recent exponential growth in the pharmaceutical and medical device sectors across Latin
America, policies and regulations are continually stretched to meet the growing concerns in
corruption, bribery and transparency. These pressures continue to influence the advancement
and evolution of the compliance function, as associations and companies strengthen internal
policies for self-regulation and meet the expectations of emerging regulatory requirements.
The Third Biennial Latin American Pharmaceutical and Medical Device Compliance Congress
draws on a powerful legacy of collaboration between pharmaceutical and medical device
companies, industry chambers and associations, key policymakers and regulators, assembling
leading decision-makers to address critical challenges and important opportunities faced by the
region. Completely reinvented for 2016, the third Congress features a combination of plenary panel
discussions and keynote addresses each morning, followed by a unique cadre of breakout options
each afternoon:
COMPLIANCE
THINK TANKS
Sessions led by and
geared toward the
compliance function,
targeted for peer-to-peer
benchmarking.
EXECUTIVE
ROUNDTABLES
Small groups facilitated
by senior thought leaders,
discussing emerging
compliance challenges.
REGIONAL
UPDATES
Country-specific debriefs
of key LATAM markets that
have experienced recent
regulatory changes.
PRACTICAL
SCENARIOS
Interactive forums
leveraging practical case
studies to navigate key
compliance topics.
Register early as seats for the Congress are expected to fill to capacity. Most multinational
companies choose to send a team representative of their entire LATAM compliance operations.
Take advantage of our group discount opportunities. Members and affiliates of Association Partners
receive an exclusive discount off the current registration rate.Inquire with your respective Association's
leadership for more information.
About the Congress Organizers:
The Latin American Ethics and Compliance Network is an
ad hoc, voluntary group of Latin American pharmaceutical,
medical device and other life sciences company compliance
professionals and legal counsel with regional oversight or
responsibility across the Latin American region who meet quarterly to discuss legal and compliance
issues and best practices trying to raise ethical standards.
A unique organization, American Conference Institute is
devoted to providing the business intelligence that senior
decision-makers need to respond to challenges both
here in the US, and around the world. Staffed by industry
specialists, lawyers and other professionals, American Conference Institute operates as a think tank,
monitoring trends and developments in all major industry sectors, the law, and public policy, with a
view to providing information on the leading edge.
Industry
Feedback:
This is an amazing
initiative and event,
organized by the Latin
American Ethics &
Compliance Network,
creating an important
forum for industries
and stakeholders from
the sector to share their
knowledge and best
practices about topics
that are really important
for the sustainable
growth of the market
and access to patients on
the best therapies and
care they need.
– Medtronic
The Latin American
Ethics and Compliance
Network has been
instrumental in
the development of
spaces for meaningful
discussion among
compliance professionals
in the Medical Device
and Pharmaceutical
industries for the past
few years. This meeting
is the keynote event
that results from the
ongoing communication
and information
exchange among
Network members. It
provides great insight
on the direction that
Compliance will take
over the next couple
of years. – Stryker
MEDIA PARTNERS:
ACIAmerican Conference Institute
Business Information in a Global Context
3. Register Now | +1 212 352 3220 Ext. 5482 | LATAMPharmaDeviceCongress.com 3
Cecilia Abe
LATAM Regional Compliance
Officer
Sanofi-Aventis
Sergio Abreu
Regional Compliance Officer
LATAM, Merck KGaA
Eunice Alcantara
Compliance and Ethics Director
Bristol Myers Squibb Latin America
Alejandra Montenegro Almonte
Member, International Group
Miller & Chevalier
Imelda Alvarez
Regional Integrity & Compliance
Officer, Latin America and
Canada
Novartis Corporativo S.A. de C.V.
Felipe Arboleda Marquez
Legal Director, Latin America
Smith & Nephew
Juan Arbona
Vice President, Compliance
Officer
Zimmer Biomet LATAM
Carrie Ashcom
Director, Global Compliance
Monitoring
Zimmer Biomet
Timothy Ayers
VP, Chief Compliance Officer
Horizon Pharma PLC
Alma Rocio Balcazar Romero
Representative, Independent
Consultant
Transparency International
Jose Alberto Campos Vargas
Partner
Sanchez Devanny Eseverri
Anita Cava
Director, Business Ethics Program
University of Miami
Andrés Cedrón
Legal Counsel and Director
of Compliance, Americas
Stryker
Felipe Coronel
Partner
Latin Lex Consulting
Lina Cortes Zepeda
Health Care Compliance Officer
MD&D North Cluster
Johnson & Johnson
Alberto de Lago
Global Regulatory Affairs Director/
Clinical and Cosmetics Studies
Genomma Lab
Gildas Durand
Principal, Fraud Investigation
& Dispute Services
EY
Esther Flesch
Partner
Trench, Rossi e Watanabe
Carolina Flonembaum
Health Care Compliance Senior
Manager
Janssen Pharmaceutical
Companies of Johnson & Johnson
Juan Francisco Millan
General Director
CETIFARMA
Adriana Fussuma
Compliance Director
Abbott Laboratories
Juan Carlos Gaona
President and General Manager
– Brazil
Abbott Laboratories
Gary Giampetruzzi
Partner, Litigation Department
Paul Hastings
Nuria Gonzalez
Head of Compliance South
America
Takeda Pharmaceutical Co Ltd
Cécile Gousset
Chair, Sponsorship & Congresses
Working Group, IFPMA
Sanofi
Andres Graziosi
Head Pharma, LACan Region
Novartis
Karla Guillén
Regional Lead Officer, Pharma
Latin America, Health Care
Compliance and Privacy
Johnson & Johnson
Keith Korenchuk
Partner
Arnold & Porter LLP
Rodolfo Lambour
Executive Director
Fedefarma
Carlos Lanardonne
Regional Compliance Officer
Sandoz
Hillary Levun
Counsel
Perkins Coie LLP
Hugo López Coll
Shareholder
Greenberg Traurig
Siaska SSS Lorenzo
Partner
Arias & Munoz
Laura Macedo
Attorney, Latin America
Quintiles
Rodrigo Salles Medina
Legal Director, Latin America
Medtronic Inc.
Angelica Morales Quezada
Vice President
IMEF Ethics Committee
Ricardo Moreno
Ethics and Business Integrity
Director of Colombia and PAC
Sanofi
Sophie Peresson
Director, Pharmaceuticals &
Healthcare
Transparency International
Mauricio Joffily Pinheiro
Head International Counsel Latin
America, Senior Legal Director
Shire Pharmaceuticals
Ariadna Quesada
Compliance Manager
International
MicroPort Orthopedics Inc.
Rafael Ribeiro
Counsel
Hogan Lovells
Marco Antonio Rivas Gonzalez
General Counsel & Chief
Compliance Officer
Bayer
Jaime Robledo
VP & General Manager
Bristol Myers Squibb Latin
America
Jorge Romo
Legal Head, Central America
and the Caribbean
Novartis
Christian-Claus Roth
Global Medical Affairs – Head
Scientific Engagement Governance
Novartis
Maria Salema
Legal Counsel & Compliance
Manager LATAM
Zimmer Biomet
Vreni Schoenenberger
Manager, Policy, Ethics and
Compliance
IFPMA
Alexandre da Cunha Serpa
Compliance Director, Business
Compliance Officer for Brazilian
Operations
CVS Onofre
Ilana Shulman
Chief Compliance Officer
Hill-Rom
Luis Villalba
Executive Director
FIFARMA
Congress Faculty
4. Join the Conversation @ACI_Pharma #LATAMcongress ACI: Pharmaceuticals/Biotech/Medical Device4
8:30 Working Group A (Registration begins at 8:00)
Anti-Bribery Compliance
Alejandra Almonte
Member, International Group
Miller & Chevalier (Washington, DC)
Alexandre da Cunha Serpa
Compliance Director, Business Compliance Officer
for Brazilian Operations
CVS Onofre (São Paulo, Brazil)
As global anti-corruption enforcement action continues to heat up and
affect LATAM and multinational life sciences companies, the importance
of successfully implementing internal controls, codes of ethics, policies
and procedures emerges as critical. This boardroom style, interactive
working group will provide a hands-on and insightful deep dive into the
challenges of rolling out effective anti-corruption programs throughout
Latin America. Attendees will benefit from a unique opportunity to ask
questions, share best practices and benchmark with their peers in this
small group setting. Working group leaders will discuss how to update
each component of a LATAM anti-corruption program, and manage the
interplay between the FCPA, UKBA and LATAM anti-bribery regulations:
• Overview of global and local regulations/standards and their impact
on the industry
• Leveraging international and national association codes and your
compliance program
• Effective compliance program localization in-country throughout
Latin America
• Exploring enforcement cases and lessons learned from the current
enforcement landscape
• Practical discussion of key compliance program elements:
accountability, reporting structure, self-assessments, policies and
procedures, monitoring, third party due diligence
Take advantage of this working group to brainstorm and benchmark with
industry cohorts to ensure that you and your LATAM compliance team
are properly prepared for the next generation in anti-bribery compliance.
12:30 Networking Luncheon
(provided for attendees of both morning and afternoon Working Groups)
13:30 Working Group B (Registration begins at 13:00)
Sponsorship and Congresses Compliance
Christian Claus Roth
Global Medical Affairs –
Head, Scientific Engagement
Governance
Novartis
Co-President
International Pharmaceutical
Congress Advisory Association
(IPCAA) (Basel, Switzerland)
Keith Korenchuk
Partner
Arnold & Porter
(Washington, DC)
Cécile Goussett
Associated Vice President,
Compliance Risk Assessment,
Education & Monitoring, Global
Ethics & Business Integrity
Sanofi
Chair, IFPMA Sponsorship &
Congresses Working Group
(Paris, France)
Dr. Juan Francisco Millán
General Director
CETIFARMA
(Mexico City, Mexico)
With a wide range of global laws, association codes of ethics, and
tools for guidance around sponsorships and congresses for health
care professionals, this industry-lead working group unpacks the Latin
American do’s and don’ts through case studies and scenarios of both
hosting compliant events as well as sponsoring healthcare professionals
to attend events. Take advantage of the smaller group setting and share
experiences, ask your most pressing questions and benchmark with
industry peers. The discussion will include the latest insights on:
• What constitutes an appropriate location and venue for an event
hosting healthcare professionals?
• How do you go about assessing whether you can support an event,
financially or otherwise, organized by another third-party?
• What leisure activities or entertainment is included in the context of
the event?
• IFPMA’s note for guidance on sponsorship of events and meetings,
and integration into your own formal screening processes
• Other emerging LATAM guidance
17:30 Working Groups End
August 23, 2016 | Pre-Congress Working Groups
• Chief Compliance Officers
• Healthcare Compliance Officers
• Chief Executive Officers
• Senior Compliance Officers
• Ethics Officers
• Vice Presidents, Directors, Managers,
Leads, Associates and Specialists of
- Latin American/Emerging Markets/
Regional Compliance
- Latin American Marketing
- Ethics and Global Compliance
- Healthcare/Medical Compliance
- Healthcare Programs and Policies
- Business Conduct and
Investigations
- Internal Controls
- Corporate Audits
- Corporate Responsibility
- Regulatory/Government Affairs
or Issues
- Legal Affairs
- Data Privacy
• General Counsel
• Compliance and Litigations Counsel
• Controllers
• International Contract Managers
• Marketing and Sales Executives
• Outside Counsel specializing in
- Pharmaceutical, Drug and
Healthcare
- Corporate Compliance
- White Collar Crime
- Dispute Resolution
- Internal Investigations
- Clinical Trails
• Forensic Auditors
• Consultancies
This Congress is specifically designed for:
The size of the audience for working groups
will be limited to optimize discussions
and benchmarking. Please reserve your
place early. Seating on a first-come,
first-served basis.
5. Register Now | +1 212 352 3220 Ext. 5482 | LATAMPharmaDeviceCongress.com 5
7:30 Registration and
Continental Breakfast
8:30
Conference Co-Chairs Opening
Remarks and Congress Vision
Imelda Alvarez
Regional Integrity & Compliance, Latin
America and Canada
Novartis (Mexico City, Mexico)
Karla Guillen
Regional Lead Officer, Pharma Latin
America, Health Care Compliance and
Privacy
Johnson & Johnson (Mexico City, Mexico)
Andres Cedron
Legal Counsel & Director of Compliance –
Americas
Stryker (Miramar, USA)
8:45
Launch of Transparency
International’s Anti-Corruption
Principles for the Latin American
Pharmaceutical Industry
Sophie Peresson
Director, Pharmaceuticals & Healthcare
Transparency International
(London, UK)
Alma Rocio Balcazar Romero
Representative
Transparency International
Independent Consultant on Governance,
Compliance and Corruption Risks
(Bogota, Colombia)
Take advantage of the first opportunity
to engage with the creators, leaders and
champions of Transparency International’s
Anti-Corruption Principles for the Latin
American Pharmaceutical Industry.
Transparency International is producing a set
of principles on bribery and conflict of interest
with accompanying guidance designed to
help companies within the Latin American
pharmaceutical industry operate to high
ethical standards. These Principles are written
for companies within the Latin American
pharmaceutical industry to voluntarily adopt
and implement, but also for a wider audience
such as regulators, law-makers and law
enforcers, who may consider the product of
this project while forming their own decisions.
Congress attendees will receive a copy of the
Principles at the Congress.
9:30 LATAM CEO Roundtable
The Tone from the Top: LATAM
CEOs Discuss Compliance
Priorities and the Role Ethics
Plays in the Reputation of the
Healthcare Industry
Jaime Robledo
Vice President & General Manager
Bristol Myers Squibb Latin America
(Buenos Aires, Argentina)
Andres Graziosi
Head Pharma, Latin American and
Canada Region
Novartis (Miami, USA)
Ricardo Marek
President & Area Head
Takeda Pharmaceuticals
(São Paulo, Brazil)
• Leveraging ethics and compliance as a tool
to grow sustainable business in LATAM
• How C-level executives can champion a
culture of ethics and compliance
• Contrasting compliance priorities in large
multinational, national, pharmaceutical and
medical device companies
• What are the top challenges LATAM
companies face in compliance?
• Q&A session with Congress delegates
(delegates will have the opportunity to
submit questions in advance)
10:15
The New Normal for Anti-Corruption
Compliance Programs and Internal
Controls:What Are Effective
Controls Amid Fast-Evolving
Enforcement and Regulatory
Landscape in Latin America
Sergio Abreu
Regional Compliance Officer – LATAM
Merck (Montevideo, Uruguay)
Andres Cedron
Legal Counsel & Director of Compliance –
Americas
Stryker (Miramar, USA)
Ilana Shulman
Chief Compliance Officer
Hill-Rom (Chicago, USA)
Gildas Durand
Principal, Fraud Investigation &
Dispute Services♠
EY (Miami, USA)
• How to successfully align anti-corruption
policies, procedures and internal controls
with LATAM culture, business practices and
market conditions
• How to assign compliance responsibilities
and accountability within the LATAM
organization
• Resolving heightened challenges to
sustaining a culture of anti-bribery
compliance in the field
• What regulators will expect you have on
file: What the latest investigations involving
LATAM companies reveal about the core
components of an effective anti-corruption
compliance and risk management program
11:00 Networking Break
11:15 LATAM Marketing Director
and Compliance Officer Roundtable
How to Effectively Balance Sales
and Compliance Objectives
Nuria Gonzalez
Head of Compliance – South America
Takeda Pharmaceutical
(Buenos Aires, Argentina)
Juan Carlos Gaona
President and General Manager – Brazil
Abbott Laboratories (São Paulo, Brazil)
• Embedding compliance into your sales and
marketing processes
• How to minimize off label promotion pitfalls
post-Amarin and Pacira
• Advertising of drugs and medical devices:
promotional review challenges
• Social media, mass media and digital age
pitfalls
12:00
Beneficiary Ownership Post
“Panama Papers”: How to Identify
Who Is the Actual Owner of Your
Counterparties
• Understanding the significance of the
Panama Papers and what the leak brings
to light
• How to identify, interpret and handle
relationships involving beneficial ownership
• What level of due diligence is required to
identify the true owners of your business
partners
• What the leak means for information and
data privacy in the context of business
transactions
12:45 Networking Luncheon
August 24, 2016 | Main Congress Day 1
6. Join the Conversation @ACI_Pharma #LATAMcongress ACI: Pharmaceuticals/Biotech/Medical Device6
Mexico Update: What the National
Mexico:What Anti-Corruption
System and Supporting Secondary
Legislation Mean for LATAM
Companies
Hugo López Coll
Shareholder
Greenberg Traurig (Mexico City, Mexico)
• Understanding jurisdiction and obligations
under the new Mexican anti-corruption laws
• Recent changes in the Code of Ethics for
public institutions
• Market opportunity analysis, regulatory
update, and important organizations
• Current bribery landscape in Mexico
August 24, 2016 | Main Congress Day 1 (cont’d)
COMPLIANCE THINK TANKS EXECUTIVE ROUNDTABLES REGIONAL UPDATES
14:00 Breakout Track I
Core Components of an Effective
Distributor Management Program
for LATAM Operations
Ariadna Quesada
Compliance Manager International
MicroPort Orthopedics B.V.
(Amsterdam, The Netherlands)
Mauricio Joffily Pinheiro
Head International Counsel Latin America,
Senior Legal Director
Shire Pharmaceuticals (São Paulo, Brazil)
Lina Cortes
Health Care Compliance Officer
Johnson & Johnson (Bogota, Colombia)
• Interacting with and onboarding of
distributors in a multinational context: how to
support upfront due diligence
• Monitoring books, records, invoices and
payments to distributors and sub-distributors
• Incorporating audit rights into your
compliance structure
• Acting on negative findings: how to establish
cause to terminate or unwind a distributor
agreement
15:00 Breakout Track II
Best Practices in Metrics and
Accountability Models: What
Leading Companies Are Doing to
Measure and Monitor the Success
of Their LATAM Compliance
Initiatives
Carrie Ashcom
Director, Global Compliance Monitoring
Zimmer Biomet (Warsaw, USA)
• How to measure the ROI of a company
culture
• Developing useful compliance metrics for
reporting to senior management and the
board
• Best practices in localizing metrics for
LATAM compliance
• Pros and cons of different methodologies
including employee surveys, self-
assessments and financial metrics
Ethics in Compliance: Interactive
Discussion on How to Resolve
Day-to-Day Ethical Dilemmas and
Influence through a Culture of
Compliance
Angelica Morales Quezada
Chairman of Ethics Commission
IMEF (Mexico City, Mexico)
Ricardo Moreno
Ethics and Business Integrity Director
of Colombia and PAC
Sanofi (Bogota, Colombia)
• How to get the ethical message to permeate
a large organization
• What to incorporate in your code of conduct
and how to define “ethics” within your
organization
• Ethical considerations for whistleblowers
programs and investigations
• Setting the tone at the top and then down to
the bottom: The role of senior management in
instilling ethics and employee engagement
Managing Conflicts between Data
Privacy Laws and Sunshine Act
Reporting: Lessons Learned from
the EU and the US
Angela Kung
Partner
Pinheiro Neto Advogados
(São Paulo, Brazil)
• Key global transparency cases with
implications for Latin America
• How do LATAM reporting considerations
differ? How can your compliance
organization be proactive?
• Anticipated LATAM regulatory frameworks
around reporting
Brazil Update: “Operation Car
Wash” and the Fast-Evolving
Investigations, Regulations and
Compliance Landscape
Eunice Alcantara
Compliance and Ethics Director
Bristol Myers Squibb Latin America
(São Paulo, Brazil)
Esther Flesch
Partner
Trench, Rossi e Watanabe
(São Paulo, Brazil)
• Status update on the “Operation Car Wash”
investigations and other high profile bribery
investigations in Brazil
• How recent government interpretations of
the FCPA and Brazil’s Clean Company Act
affect your risk assessment
• Market opportunity analysis, regulatory
update, newfound risk areas and how to
strengthen controls around those risks
16:00 Networking Break
7. Register Now | +1 212 352 3220 Ext. 5482 | LATAMPharmaDeviceCongress.com 7
August 24, 2016 | Main Congress Day 1 (cont’d)
COMPLIANCE THINK TANKS EXECUTIVE ROUNDTABLES COMPLIANCE THINK TANKS
Where Companies Go Wrong with
Scientific and Educational Events:
Top 10 Compliance Pitfalls and
How to Detect Risks
Bruno Ferraz de Camargo
Partner
AZFC (São Paulo, Brazil)
• Dos and don’ts when selecting venues, and
locations for events
• Grants to associations to hold conferences:
When and how much due diligence to
conduct on meeting planners?
• Speaker programs, KOLs and thought
leaders, and their use in marketing and
promotional strategies: How to minimize risks
• What to look for when choosing to provide
support to a third-party event
• Review of event assessment tools to best
detect risks
Partnering Corporate Compliance
and Medical Ethics to Ensure
Quality Patient Care
• Leveraging compliance as a tool to deliver
optimal value to patients
• What is being done to share the onus of
compliance throughout the patient care
value chain?
16:15 Breakout Track III
Where Life Sciences Companies
Face the Greatest Risk of
Anti-Corruption Enforcement:
A Practical Review of the Latest US
DOJ and SEC Enforcement Cases
Gary Giampetruzzi
Partner
Paul Hastings (New York, USA)
• What are the current US DOJ and SEC
enforcement priorities and targets?
• What are the implications of increased FCPA
scrutiny and activity in Latin America?
• USDOJ coordination with international
authorities and the rise of multi-jurisdictional
investigations
• Increased enforcement of the books and
records provision by the SEC
• What is expected of your company when the
industry is under investigation?
• Review of recent cases and implications in
LATAM
17:15 Interactive, Open Mic Q&A Roundtable
Transparency International’s Anti-Corruption Principles for the Latin American Pharmaceutical Industry and
Next Steps
This interactive session allows for an open dialogue and Q&A session around the principles, with a focus on their practical application within your
existing compliance program. We encourage you to submit your question confidentially in advance to TIprinciples@americanconference.com.
18:00 Congress Adjourns to Day 2
Argentina
Brazil
Colombia
Ecuador
Peru
Uruguay
United States
Canada
Austria
France
Spain
Switzerland
United Kingdom
Guatemala
Mexico
Panama
Puerto Rico
Gathering a Global Audience
Industry Breakdown
Internal Audit, Controls
Executive Officers, Vice Presidents
General Counsel
Medical and Healthcare Directors
Partners and Principals
Ethics Officers and Directors
Legal Officers, Directors, Managers
Regulatory Affairs
Compliance Officers, Directors, Managers
Executive Directors
Top
Titles
58% Pharmaceutical and
Medical Devices Companies
17% Consultants
11% Life Science Trade Associations
8% Biotech and Healthcare Services
6% Law Firms
8. Join the Conversation @ACI_Pharma #LATAMcongress ACI: Pharmaceuticals/Biotech/Medical Device8
7:30 Registration and
Continental Breakfast
8:30
Conference Co-Chairs Opening
Remarks
8:45
Building Relationships while
Maintaining Compliance:
Practical Discussion on the
Do’s and Don’ts of Interacting
with HCPs in Latin America
Carlos Lanardonne
Regional Compliance Officer
Sandoz (Miami, USA)
Felipe Coronel
Partner
Latin Lex Consulting (Panama City, Panama)
Siaska SSS Lorenzo
Partner
Arias & Munoz (Panama City, Panama)
• Anti-Corruption considerations with health
care professionals partially in the public
sector and partially in the private sector
• Navigating the line between hospitality and
a bribe
• Crafting appropriate guidelines for HCP
interaction in Latin America
• Interactions with physicians, pharmacists,
hospitals and others
• Examples of key LATAM violations and
investigations involving HCP interaction
9:45 Global CCO Interview
The Structure of Global Ethics:
Interview with Senior CCOs from
US and Europe
Timothy Ayers
Vice President, Chief Compliance Officer
Horizon Pharma PLC (Chicago, USA)
Gildas Durand
Principal, Fraud Investigation & Dispute
Services
EY (Miami, USA)
• Benchmarking LATAM standards against
global standards
• How HQ is assigning accountability and
responsibility for compliance across the
global organization
• Defining procedures when a non-compliance
issue is uncovered
• Implementing effective compliance training
programs globally and locally
• How to benefit from compliance work
performed across the globe: Dos and don’ts
when sharing information with other offices
10:45 Networking Break
11:00
Transparency and Disclosure
in Transfers of Value: How to
Satisfy Reporting Requirements
and Assess the Risks Posed
by Disclosure Amid Higher
Government Expectations
Jose Alberto Campos Vargas
Partner
Sanchez Devanny Eseverri
(Mexico City, Mexico)
Marco Antonio Rivas Gonzalez
General Counsel & Chief Compliance
Officer
Bayer (Mexico City, Mexico)
• Evaluation of current LATAM regulatory
structures and disclosure requirements
• Lessons learned from the US Sunshine Act
and that raise LATAM standards
o Reporting by foreign parent companies
for payments made within the US
o Reporting by US-based companies for
payments made outside of the US
• How to prepare LATAM compliance officers
for the next generation in transparency
• What mechanisms should companies have
in place to demonstrate a payment is not a
kickback to an HCP or a government official
11:45 LATAM Pharmaceutical and
Medical Device Association Roundtable
Enhancing LATAM Ethical
Practices and Raising Standards
for the Industry
Dr. Juan Francisco Millán
General Director
CETIFARMA (Mexico City, Mexico)
Rodolfo Lambour
Executive Director
Fedefarma (Guatemala)
Vreni Schoenenberger
Manager, Policy, Ethics and Compliance
IFPMA (Geneva, Switzerland)
Luis Villalba
Executive Director
FIFARMA (Santiago, Chile)
Join leaders of key Latin American
pharmaceutical and medical device
associations as they unpack what is being
done to enhance ethical standards in life
sciences through codes of conduct, policy
best practices, regulatory action and industry
collaboration.
12:45 Networking Luncheon
August 25, 2016 | Main Congress Day 2
Global Sponsorship Opportunities
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
9. Register Now | +1 212 352 3220 Ext. 5482 | LATAMPharmaDeviceCongress.com 9
Data Analytics in Practice:
Examples of How to Leverage Big
Data to Detect Non-Compliance
Risks and Improve Investigative
and Audit Outcomes
Cecilia Abe
Associate Vice President for Compliance,
Latin America
Sanofi Group (Panama City, Panama)
• Compliance “dashboard” in practice
• Automated controls to flag suspicious
payments
• Best practices for data interpretation during
investigations
• Incorporating predictive coding into your
data management
How to Properly Respond to
Requests for Payment, Kickbacks
or a Bribe
Rafael Ribeiro
Counsel
Hogan Lovells (Miami, USA)
Jorge Romo
Legal Head, Central America and the
Caribbean
Novartis (Panama City, Panama)
• Best practices and policies to implement
within your company’s code of conduct
• Mitigating steps when engaging third parties
to deal with approval processes for permits
and or licenses
• How to deal with requests in small local
communities and from low-level bureaucrats
• Reporting findings to compliance officers,
audit committees and legal counsel and
when to escalate the issue to the home office
August 25, 2016 | Main Congress Day 2 (cont’d)
COMPLIANCE THINK TANKS EXECUTIVE ROUNDTABLES PRACTICAL SCENARIOS
14:00 Breakout Track IV
How to Avoid Internal and
External “Conflicts of Interest”:
Minimizing Risks from Political
Contribution, Donations, Gifts
and Entertainment
Rodrigo Medina
Senior Legal Director & Compliance –
Latin America
Medtronic (Miami, USA)
• Best practices in policies or ethical codes to
prevent conflicts of interest
• Mitigation techniques once a conflict has
been identified
• Defining what is reasonable and what is
customary in the context of Latin American
culture
Roundtable on the Evolution of the
Compliance Function, the Push
Toward Individual Liability and How
to Groom the Next Generation of
Compliance Executives
Felipe Arboleda Marquez
Legal Director – Latin America
Smith & Nephew (Bogota, Colombia)
Juan Arbona
Vice President, Compliance Officer LATAM
Zimmer Biomet
(Palm Beach Gardens, USA)
Anita Cava
Director, Business Ethics Program
University of Miami (Miami, USA)
• LATAM repercussions of the Yates Memo
• How is the responsibility inherent to the
compliance function changing?
• How should compliance training change to
follow suit?
• Tools for recruiting
Third Parties Under the Microscope:
Practical Scenarios When
Conducting Third Party Audits
Adriana Fussuma
Compliance Director
Abbott Laboratories (São Paulo, Brazil)
• Incorporating contractual audit rights into
your compliance structure
• Audit practices for new versus longstanding
business partners
• Determining appropriate audit frequency
• Compliance 2.0 – What industry is doing to
maintain the auditing process
15:00 Breakout Track V
Compliance Officers Think Tank:
How to Localize Compliance
without Compromising Integrity
Carolina Flomenbaum
Health Care Compliance Senior Manager
The Janssen Pharmaceutical Companies
of Johnson & Johnson (São Paulo, Brazil)
Maria Salema
Legal Counsel & Compliance Manager
LATAM
Zimmer Biomet (São Paulo, Brazil)
• How to localize your compliance program
effectively to meet the needs and regulatory
environment of each country
• Sensible staffing structures for regional and
local compliance activities in Latin America
16:00 Networking Break
10. Join the Conversation @ACI_Pharma #LATAMcongress ACI: Pharmaceuticals/Biotech/Medical Device10
COMPLIANCE THINK TANKS EXECUTIVE ROUNDTABLES Invitation-Only Roundtable
17:15 Congress Concludes
August 25, 2016 | Main Congress Day 2 (cont’d)
How to Ensure Integrity, Ethics
and Transparency in Clinical Trials
Alberto de Lago
Global Regulatory Affairs Director, Clinical
and Cosmetics Studies
Genomma Lab (Mexico City, Mexico)
Laura Macedo
Attorney, Latin America
Quintiles (São Paulo, Brazil)
• Which clinical trial activities have raised red
flags to enforcement authorities?
• Managing risks when making payments to
principal investigators, HCPs or consultants
in connection with a clinical trial
• Ensuring that all payments are disclosed to
and approved by sponsor
• Legal and ethical concerns regarding
“donated equipment” for use during a trial
• Vetting your CRO to maintain clinical trial
integrity
• To what extent can a sponsor rely on the
CRO’s compliance program?
Association Meeting on
Transparency International
Latin American Principles
16:15 Breakout Track VI
Training Best Practices
and Benchmarking: Case
Studies onThe Life Cycle
of an Effective Ethics and
ComplianceTraining Program
Hillary Levun
Counsel
Perkins Coie LLP (Chicago, USA)
• Key success factors for culturally-
sensitive compliance training and
implementation
• Organizing an effective training
program, whether online, in-person or
a combination of both
• Tips for making compliance training
appealing to staff
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 “Pharma & Medical Device
Compliance Congress” or visit the online reservation page.
Venue: Hilton Panama
Address: Balboa Avenida & Aquilino De La Guardia, Panama City, Panama
Reservations: +507-280-8080
Online Reservation: tinyurl.com/PharmaCongress16
12. TM-LAE
REGISTRATION CODE
Attention Mailroom
If undeliverable to addressee, please forward to: Chief Compliance
Officer, Director or Manager, LATAM Ethics and Compliance,
In-House Counsel, Governance and Healthcare Compliance
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
Third Latin American
Pharmaceutical and Medical Device
Compliance Congress
Third Latin American
Pharmaceutical and Medical Device Compliance Congress
August 23 – 25, 2016 | Hilton Panama, Panama City
August 23 – 25, 2016 | Hilton Panama, Panama City
ACIAmerican Conference Institute
Business Information in a Global Context
Spanish-English Simultaneous Translation
Available During the Event!
La Conferencia se llevará a cabo en Español
e Inglés con Traducción Simultánea!
EARN CLE/CPE
CREDITS
