PROGRAM SCHEDULED for April 15-18, 2024 | In-Person | São Paulo, Brazil
DAY 1 Monday | |
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9:30-10:15 |
Welcome, Overview, Introductions & Ice Breaker 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. Timothy Glynn |
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 Nicole Recchi Aun Adrián del Paso MODERATOR: 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. Patrícia Fukuma 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 |
3:35-3:50 |
Break |
3:50-4:45 |
Culture, Ethics and Compliance |
DAY 2 TUESDAY | |
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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 |
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. María Vanina Caniza Henrique K. Frizzo |
1:00-2:00 |
Lunch Break |
2:00-2:40 |
Antitrust Regulations in the Life Sciences Industry Santiago Del Río 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 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 Gustavo Luis Morales Oliver Michel Sancovski |
4:55-5:30 |
Virtual Networking Reception |
DAY 3 WEDNESDAY | |
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10:00-11:00 |
Compliance Officers’ Panel Discussion Lina María Cortés Caterina Fazenda Claudia Hernández Loustalot Laclette Felipe Kietzmann MODERATOR: Timothy Glynn |
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. |
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 |
2:25-3:35 |
Monitoring Programs Monitoring, auditing, and how to improve upon these programs within your companies. Lina María Cortés 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 |
DAY 4 THURSDAY | |
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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 |
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 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 Claudia Hernández Loustalot Laclette |
4:45 |
Closing Remarks Timothy Glynn Rosa Alves |