PROGRAM SCHEDULED for April 15-18, 2024 | In-Person | São Paulo, Brazil
Day 1: Monday, April 15, 2024
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)
Learn more about Timothy Glynn
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)
Break
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)
Nicole Recchi Aun
Senior Associate, Life Sciences, Pinheiro Neto Advogados (São Paulo)
Adrián del Paso
Partner & Chair, Environmental, Life Sciences, Healthcare
& Regulatory Practices, Assembla (Mexico City)
Martín Javier Mosteirin
Partner of the Life Sciences and Healthcare Departments, Marval (Buenos Aires)
Camila Leone
Member, Life Sciences & Healthcare Department, Marval (Buenos Aires)
Moderator: Luciano Hoffmann
Country Legal Head, Novartis Brazil (São Paulo)
Lunch
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.
Patrícia Fukuma
Partner, Fukuma Advogados & Consultores (São Paulo)
Luis Joaquín Serrano Sánchez
Country Manager, IRIS Global LLC (Mexico City)
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 & Member, Regulatory Law Team & Compliance,
Anticorruption, and Investigations Team, Marval (Buenos Aires)
Gabriela Morette
Privacy Director, LatAm, Global Privacy, Johnson & Johnson (São Paulo)
Break
Culture, Ethics and Compliance
Maria Leonor de Freitas Rios
Founding Partner, Freitas Rios Advogados Associados (São Paulo)
Day 2: Tuesday, April 16, 2024
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)
Break
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.
Heloisa Barroso Bloisi
Partner, Trench Rossi Watanabe (São Paulo)
Felipe Ferenzini
Partner, Trench Rossi Watanabe (São Paulo)
Lunch Break
Antitrust Regulations in the Life Sciences Industry
Camilla Paoletti
Partner, Competition Practice Area, BMA Advogados (São Paulo)
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
Principal/Partner, Fraud Investigation & Dispute Services (FIDS), Ernst & Young (EY)(Miami, United States)
Bryan Parr
Of Counsel, Gibson Dunn (Washington, DC, United States)
Break
Compliance Officers’ Panel Discussion
Caterina Fazenda
Latam Executive Director for Legal & Compliance, Ultragenyx (São Paulo)
Fernando Fagundes Iazzetta
Legal & Compliance Officer China & International - Legal & Corporate Affairs, Chiesi Farmaceutica Ltda (São Paulo)
Lilian Lustre
Head of Ethics & Business Integrity for Latam & Member of E&BI Global Leadership Team, Sanofi (São Paulo)
Adriana Mayumi Fussuma
Legal & Compliance Head LATAM, Medison Pharma (São Paulo)
Moderator: Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School (New Jersey, United States)
Networking Reception
Timo Cucina, Vila Olímpia
Avenida Presidente Juscelino Kubitschek, 1909, São Paulo
Day 3: Wednesday, April 17, 2024
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)
Michel Sancovski
Partner, Global Investigations & White Collar Defense, Mayer Brown LLP (São Paulo)
Break
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.
Roberta Martinho
Senior Manager, Forensic & Integrity Services, Ernst & Young (EY) (São Paulo)
Adriana Mayumi Fussuma
Legal & Compliance Head LATAM, Medison Pharma (São Paulo)
Lunch Break
Monitoring Programs
- Monitoring, auditing, and how to improve upon these programs within your companies.
Andre Souza
Senior Manager, Global Assessment & Consulting Services (GACS)
LatAm, Johnson & Johnson (São Paulo)
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 Advogados (São Paulo)
Break
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.
Patricia Miguel
Partner, Forensic & Integrity Services, Ernst & Young (EY) (São Paulo)
Flavia Paulino
Compliance Director LATAM, Novo Nordisk (São Paulo)
Day 4: Thursday, April 18, 2024
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.
Júlio Garcia Morais
Partner, Lopes Muniz Advogados (São Paulo)
Break
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.
Fernando Fagundes Iazzetta
Legal & Compliance Officer China & International - Legal & Corporate Affairs, Chiesi Farmaceutica Ltda (São Paulo)
Interactive Team Case Study - Group Exercise
Lunch Break
Interactive Team Case Study - Group Exercise
Interactive Team Case Study
Caterina Fazenda
Latam Executive Director for Legal & Compliance, Ultragenyx (São Paulo)
Closing remarks & Awarding of Program Certificates
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey, United States)
