Program Agenda


 

 

Latin America Healthcare Compliance Certificate Program

[email protected] | 973-642-8871

PROGRAM SCHEDULED for April 25-28, 2022 | Virtual

All times are in Eastern time. (Last updated April 1, 2022)
DAY 1 Monday, April 25, 2022

9:30-10:15

Welcome, Overview, Introductions & Ice Breaker

Rosa Alves

Rosa Alves
Assistant Dean for Global Compliance, Seton Hall Law School (New Jersey)

Learn more about Rosa Alves >>

10:15-11:10

Aligning the “Why” and “How” of Compliance

A look at why business ethics is an important part of compliance and a company’s culture.

Jacob Elberg

Professor Jacob T. Elberg
Associate Professor of Law, Seton Hall Law School (New Jersey)

Learn more about Prof. Elberg >>

11:10-11:25

Break

11:25-12:45

Advertising & Promotion of Drugs & Medical Devices

A discussion of the key requirements and regulations for advertising and promoting prescription drugs and medical devices, special risk areas for pre-launch activities, and social media.

Ignacio Gillmore

Ignacio Gillmore
Partner, Carey Law Firm (Santiago)

Learn more about Ignacio Gillmore >>

Nicole Recchi Aun

Nicole Recchi Aun 
Senior Associate, Life Sciences, Pinheiro Neto Advogados (São Paulo)

Learn more about Nicole Recchi Aun >>

Adrián del Paso

Adrián del Paso
Partner, Ibarra, del Paso, y Gallego, S.C. (Mexico City)
Learn more about Adrián del Paso >>

Claudia Farjat

MODERATOR: Claudia Farjat
Country Legal Head, Novartis (Chile)
Learn more about Claudia Farjat >>

12:45-1:45

Lunch Break

1:45-2:45

Drug & Device Development & Approval Process

A comprehensive overview of the laws/regulations and key requirements involved in the new drug and device approval process, including classifying and testing new products, the application process, and the various pathways to marketing a product.

Patricia Fukuma

Patrícia Fukuma 
Attorney, Fukuma Advogados e Consultores Juridicos (São Paulo)

Learn more about Patrícia Fukuma >>

Maritza Moncayo

Maritza Moncayo  
President, IRIS GLOBAL (Chicago)

Learn more about Maritza Moncayo >>

2:50-3:35

Transparency in Latin America

An overview of the disclosure reporting requirements for transfers of value to health care professionals; what are the risks and what have we learned from other regions.

David Quiroz

David Quiroz
Director, Law Department, Johnson & Johnson (Bogotá)

Learn more about David Quiroz >>

3:35-3:50

Break

3:50-4:45

Culture, Ethics and Compliance

Imelda Alvarez

Imelda Alvarez
CEO and Founder, Comply Latam S.C. (Mexico)

Learn more about Imelda Alvarez >>

DAY 2 TUESDAY, April 26, 2022

10:00–11:30

Global Anti-Corruption Enforcement

A session focusing on the Foreign Corruption Practices Act, the UK Bribery Act, and global anti-corruption enforcement.

Jonathan Stevens

Jonathan Stevens
Of Counsel, Litigation Department, Paul Hastings, LLP (Los Angeles)

Learn more about Jonathan Stevens >>

11:30-11:45

Break

11:45-1:00

Anti-Corruption Risks & Enforcement in LATAM Markets

Key risk areas for the life sciences industry, including with respect to third parties, global anti-corruption laws, industry trends, and lessons learned from other high-risk markets.

Maria Vanina Caniza

María Vanina Caniza 
Partner, Baker McKenzie (Buenos Aires)

Learn more about María Vanina Caniza >>

Henrique K. Frizzo

Henrique K. Frizzo
Partner, Trench, Rossi & Watanabe (São Paulo)

Learn more about Henrique K. Frizzo >>

1:00-2:00

Lunch Break

2:00-2:40

Antitrust Regulations in the Life Sciences Industry

Santiago Del Río

Santiago Del Río
Partner, Marval, O’Farrell y Mairal (Argentina)

Learn more about Santiago Del Río >>

Matias Giaccardi

Matías Giaccardi 
Head of Legal, Latam (w/o Brazil) Takeda (Argentina)

Learn more about Matías Giaccardi >>

2:45-3:35

Conducting an Internal Investigation

An examination of what conduct triggers the need for an internal investigation, who should be involved, and how to handle the results.

Gildas Durand

Gildas Durand
Principal/Partner, Fraud Investigation & Dispute Services, E&Y (Miami)

Learn more about Gildas Durand >>

Andrew Levine

Andrew Levine
Partner, Debevoise & Plimpton LLP (New York)

Learn more about Andrew Levine >>

3:35-3:50

Break

3:50-4:50

Talking To Your Government: Dealing with Enforcers & Prosecutors

A discussion of the interaction and policies that exist between the private and public sectors and how to navigate government relations.

Daniel R. Alonso

Daniel R. Alonso
Partner, Buckley LLP (New York)

Learn more about Daniel R. Alonso >>

Gustavo Luis Morales Oliver

Gustavo Luis Morales Oliver
Partner, Marval, O’Farrell y Mairal (Buenos Aires)

Learn more about Gustavo Luis Morales Oliver >>

Michel Sancovski

Michel Sancovski 
Partner, Tauil & Chequer Advogados / Mayer Brown  (São Paulo)

Learn more about Michel Sancovski >>

4:55-5:30

Virtual Networking Reception 

DAY 3 WEDNESDAY, April 27, 2022

10:00-11:00

Compliance Officers’ Panel Discussion

Lina María Cortés

Lina María Cortés
Regional Health Care Compliance Officer, Northern Region, Johnson & Johnson Medical Devices (Bogotá)

Learn more about Lina María Cortés >>

Caterina Fazenda

Caterina Fazenda
Executive Director, Legal & Compliance, LATAM, BioMarin (Brazil)

Learn more about Caterina Fazenda >>

Claudia Hernández Loustalot Laclette

Claudia Hernández Loustalot Laclette
Global OEC Director, Office of Ethics and Compliance, AbbVie (Chicago)

Learn more about Claudia Hernández Loustalot Laclette >>

Felipe Kietzmann

Felipe Kietzmann 
Regional Compliance Director, Latin America, Grünenthal (Panama)

Learn more about Felipe Kietzmann >>

Jacob Elberg

MODERATOR: Jacob T. Elberg 
Associate Professor of Law, Seton Hall Law School (New Jersey)

Learn more about Prof. Elberg >>

11:05-12:10

Strengthening Compliance Programs Through Data Analytics

A look at what data analytics is and how it can be used to help detect, predict, and prevent future compliance risks.

Henry Matta

Henry Matta
Senior Manager, EY Forensic & Integrity Services (Perú)

Learn more about Henry Matta >>

Cecilia Melzi

Cecilia Melzi
Partner, Forensic & Integrity Risk Services, EY (Perú)

Learn more about Cecilia Melzi >>

12:10-1:10

Lunch Break

1:10-2:20

Data Protection Risks in the Health Care Industry—An Accountability Approach

Overview of the key data protection risks facing multinationals; the complex regulatory landscape for privacy and data protection in LATAM & globally.

     
Benny Spiewak

Benny Spiewak
Founding Partner, SPLAW Advogados (São Paulo)

Learn more about Benny Spiewak >>

2:25-3:35

Monitoring Programs

Monitoring, auditing, and how to improve upon these programs within your companies.

Lina María Cortés

Lina María Cortés 
Regional Health Care Compliance Officer, Northern Region, Johnson & Johnson Medical Devices (Bogotá)

Learn more about Lina María Cortés >>

Rafael Peña

Rafael Peña
Global Assessment & Consulting Services Director (GACS) LatAm, Johnson & Johnson (Colombia)

Learn more about Rafael Peña >>

3:35–3:50

Break

3:50–5:00

Assessing Third Party Risk

Best practices on how to conduct tiered due diligence and implement internal controls to mitigate the risks associated with third parties.

   
Gildas Durand

Gildas Durand 
Principal/Partner, Fraud Investigation & Dispute Services, E&Y (Miami)

Learn more about Gildas Durand >>

 
DAY 4 THURSDAY, April 28, 2022

10:00–11:00

Industry Interactions with Patient Organizations

Discussion of the types of industry interactions with patients and patient organizations and how to identify and manage the ethical issues and potential conflicts of interest that may arise.

Marcos Lobo de Freitas Levy

Marcos Lobo de Freitas Levy
Senior Partner, A. Lopes Muniz Advogados Associados (São Paulo)

Learn more about Marcos Lobo de Freitas Levy >>

11:05-12:30

Building a Compliance Team & Creating a Culture of Compliance

An examination of ways to recruit, develop, and promote a team of compliance professionals; interactive exercise describing methods that companies can use with employees to help build an ethical business culture.

Claudia Hernández Loustalot Laclette

Claudia Hernández Loustalot Laclette
Global OEC Director, Office of Ethics and Compliance, AbbVie (Chicago)

Learn more about Claudia Hernández Loustalot Laclette >>

Angela Neira

Angela Neira
Office of Ethics & Compliance Director for Colombia, Ecuador, Perú & Venezuela, Abbott (Bogotá)

Learn more about Angela Neira >>

12:30–1:30

Lunch Break

1:30–3:00

Interactive Team Case Study

Group Exercise

3:00–3:15

Break

3:15–4:45

Interactive Team Case Study

Lina María Cortés

Lina María Cortés
Regional Health Care Compliance Officer, Northern Region, Johnson & Johnson Medical Devices (Bogotá)

Learn more about Lina María Cortés >>

Claudia Hernández Loustalot Laclette

Claudia Hernández Loustalot Laclette
Global OEC Director, Office of Ethics and Compliance, AbbVie (Chicago)

Learn more about Claudia Hernández Loustalot Laclette >>

4:45

Closing Remarks

Jacob Elberg

Professor Jacob T. Elberg
Associate Professor of Law, Seton Hall Law School (New Jersey)

Learn more about Prof. Elberg >>

Rosa Alves

Rosa Alves
Assistant Dean for Global Compliance, Seton Hall Law School (New Jersey)

Learn more about Rosa Alves >>


Celebrating 15 years in Compliance


Learn more about our programs.