Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey, United States)
PROGRAM SCHEDULED for September 21-24, 2026 |In-Person/Hybrid | Bogotá, Colombia
[email protected] | 973-642-8382
All times are in Bogotá, Colombia 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, DLA Piper (Mexico City)
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: Patricia Hernández
Legal Associate Director, Astellas Pharma (Bogotá)
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.
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)
Andrea Celis Bohorquez
Legal, Ethics & Compliance Manager, Novo Nordisk (Bogotá)
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
10:55-12:20
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)
Cecilia Stahlhut
Partner, Hogan Lovells (Mexico City)
12:10-1:10
Lunch
1:10-2:15
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.
Alejandra Villada
Senior Assoiate, Lloreda Camacho & Co. (Bogotá)
Lucia Hernandez Roldan
Sanofi
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.
Gildas Durand
Global Investigations, Risk Management & Compliance Senior Executive (Miami)
3:30-3:45
Break
3:45 - 5:00
Compliance Officers’ Panel Discussion
Sebastián Unda McFarlane
Head of Legal & Compliance, Roche (Colombia)
Maria Camila Ruiz Suarez
Head of Legal & Compliance for Colombia and Channel Partnership Markets in Latin America, Cardinal Health
Moderator: Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School (New Jersey, United States)
5:00-6:30
Networking Reception - Tremé
9:30 - 10:40
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)
Learn more about Marcos Lobo de Freitas Levy
10:40 - 10:55
Break
10:55 - 12:05
Antitrust Regulations in the Life Sciences Industry
Felipe Serrano
Managing Partner, Serrano Martinez CMA (Bogotá)
Darío Cadena
Partner, Lloreda Camacho & Co. (Bogotá)
12:05 - 1:10
Lunch
1:10 - 2:20
Monitoring Programs
Monitoring, auditing, and how to improve upon these programs within your companies.
David Quiroz
Legal Director, Orthopedics, Johnson & Johnson
2:25 - 3:55
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
Founding Partner, SPLAW (São Paulo)
Paola María Posada Cuello
Lead Counsel - Andean, Takeda
Carlos Calderón
Associate Legal Director for North LATAM & South Cone, BioMarin
3:55 - 4:05
Break
4:05 - 5:10
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.
Cecilia Stahlhut
Partner, Hogan Lovells (Mexico City)
Lucia Hernandez Roldan
Sanofi
9:00 - 10:10
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.
Sandra Calderon
Associate Partner, Forensic and Integrity Services Leader,
EY Colombia
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.
Sebastián Unda McFarlane
Head of Legal & Compliance, Roche (Colombia)
11:30 - 1:00
Interactive Team Case Study - Group Exercise
1:00 - 2:00
Lunch
2:00 - 3:30
Interactive Team Case Study
Ana María Castro
Partner & Director of the Life Sciences Practice, Lloreda Camacho & Co. (Bogotá)
Carolina Forero Isaza
Johnson & Johnson (Bogotá)
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)
Martin Mosteirin
Partner, Health Law and Sanitary Law Department, Marval (Buenos Aires)
3:45
Refreshments - Grab & Go
