Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey, United States)
PROGRAM SCHEDULED for March 24-27, 2025 | In-Person/Hybrid | Mexico City, Mexico
[email protected] | 973-642-8382
All times are in Mexico City time (Central Standard Time)
9:00 - 9:40
Welcome, Overview, Introductions & Ice Breaker
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey, United States)
Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School (New Jersey, United States)
9:45 - 10:40
Aligning the “Why” and “How” of Compliance
- A look at why business ethics is an important part of compliance and a company’s culture.
Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School (New Jersey, United States)
10:40 - 10:55
Break
10:55 - 12:25
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
Partner & Co-Head, Life Sciences and Biotechnology & Public Law Groups, Carey Law Firm (Santiago)
Adrián del Paso
Partner & Chair, Environmental, Life Sciences, Healthcare
& Regulatory Practices, Assembla (Mexico City)
Martín Javier Mosteirin
Partner, Health Law and Sanitary Law Department, Marval (Buenos Aires)
Camila Leone
Member, Life Sciences & Healthcare Department, Marval (Buenos Aires)
Ana María Castro
Partner & Director of the Life Sciences Practice, Lloreda Camacho & Co. (Bogotá)
Learn more about Ana María Castro
Paulo Rosito
Partner of Life Sciences & Healthcare, Souto Correa Advogados (São Paulo)
Moderator: Juan Pablo Malfavon
Legal Director LATAM, AstraZeneca (Mexico City)
12:25 - 1:25
Lunch
1:25 - 2:40
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.
Guillermo Govela
Head, Life Sciences and Healthcare Practice, Creel, García Cuéllar, Aiza y Enríquez, S.C. (Mexico City)
Luis Joaquín Serrano Sánchez
Country Manager, IRIS Global LLC (Mexico City)
Maritza Moncayo
President & Founder, IRIS Global LLC (Mexico City)
2:45 - 3:55
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.
Lorena Schiariti
Partner, Regulatory and Administrative Law Team & Compliance, Anticorruption, and Investigations Team, Marval (Buenos Aires)
Mónica Gutiérrez
Compliance Officer, Stryker México/Argentina/Chile (Mexico City)
Rodrigo Borda Olarte
Latam & Mexico Ethics and Compliance Director (CCEO), Astellas Farma México (Mexico City)
3:55 - 4:10
Break
4:10 - 5:00
Culture, Ethics and Compliance
Imelda Álvarez
CEO & Founder, Comply Latam, S.C. (Mexico City)
9:30 - 10:40
Global Anti-Corruption Enforcement
- A session focusing on the Foreign Corruption Practices Act, the UK Bribery Act, and global anti-corruption enforcement.
Jonathan Stevens
Partner, Litigation Department, Paul Hastings, LLP (Los Angeles, United States)
10:40 - 10:55
Break
10:55 - 12:10
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.
Guillermo Larrea
Partner, Hogan Lovells (Mexico City)
Alvaro Torres
Mexico Compliance Director, Pfizer Mexico (Mexico City)
12:10 - 1:10
Lunch Break
1:10 - 2:15
Antitrust Regulations in the Life Sciences Industry
Gustavo Alcocer
Partner, Chair Corporate and Commercial Law Group / Co-Chair Life Sciences Group, OLIVARES (Mexico City)
Irma García Morales
Regional Compliance Head - Mexico and Latam, Sanfer (Mexico City)
Juan Carlos Burgos
Partner, Galicia (Mexico City)
2:20 - 3:30
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.
Giovanna Scheleder
Senior Manager, Forensic & Integrity Services, EY (Ernst & Young) (Mexico City)
3:30 - 3:45
Break
3:45 - 5:00
Compliance Officers’ Panel Discussion
Caterina Fazenda
Latam Executive Director for Legal & Compliance, Ultragenyx (São Paulo)
Juan Pablo Malfavon
Legal Director LATAM, AstraZeneca (Mexico City)
Olga Victoria Prieto Zamora
Lead Counsel Latam, Zoetis (Mexico City)
Alvaro Torres
Mexico Compliance Director, Pfizer Mexico (Mexico City)
Irma García Morales
Regional Compliance Head - Mexico and Latam, Sanfer (Mexico City)
Moderator: Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School (New Jersey, United States)
5:15 - 7:00
Networking Reception
Colmillo Masaryk located at Aristótles, #124, Polanco, Mexico City
9:30 - 10:45
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.
Paulo Rosito
Partner of Life Sciences & Healthcare, Souto Correa Advogados (São Paulo)
Anderson Ribeiro Oliver
Life Sciences - Partner, Souto Correa Advogados (São Paulo)
Juan Pablo Malfavon
Legal Director LATAM, AstraZeneca (Mexico City)
Cecilia Stahlhut
Partner, Hogan Lovells (Mexico City)
10:45 - 11:00
Break
11:00 - 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.
José Figueira
Partner, Forensic & Integrity Services, EY (Ernst & Young) (Mexico City)
Pablo Montes
Senior Manager, Forensic & Integrity Services, EY México (Ernst & Young)(Mexico City)
12:10 - 1:10
Lunch Break
1:10 - 2:20
Monitoring Programs
- Monitoring, auditing, and how to improve upon these programs within your companies.
Diana Cortés Navarro
Health Care Compliance Manager, Johnson & Johnson MedTech Mexico (Mexico City)
2:25 - 3:35
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.
Abraham Díaz
Co-Chair, Litigation Team and Data Privacy and IT Industry Groups, OLIVARES (Mexico City)
Arturo Ánimas
Legal & Compliance Director LATAM, Lundbeck (Mexico City)
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.
Sergio Medina
Associate Partner, Forensic & Integrity Services, EY (Ernst & Young) (Buenos Aires, Argentina)
Cecilia Stahlhut
Partner, Hogan Lovells (Mexico City)
9:00 - 10:10
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
Senior Partner, Lopes Muniz Advogados (São Paulo, Brazil)
Lisandro Herrera
Partner, Galicia (Mexico City)
10:10 - 10:25
Break
10:25 - 11:25
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.
Sara Calderón
Legal and Business Conduct Director for Latin America Mid Size Markets, Gilead Sciences (Bogota)
11:30 - 1:00
Interactive Team Case Study - Group Exercise
1:00 - 2:00
Lunch Break
2:00 - 3:30
Interactive Team Case Study
Sara Calderón
Legal and Business Conduct Director for Latin America Mid Size Markets, Gilead Sciences (Bogota)
Olga Victoria Prieto Zamora
Lead Counsel Latam, Zoetis (Mexico City)
3:30
Closing Remarks & Awarding of Program Certificates
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey, United States)
3:45
Refreshments - Grab & Go
