Latin America Healthcare Compliance Certificate

Welcome, Overview Introductions & Ice Breaker

Aligning the “Why” and “How” of Compliance

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

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.

 

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.

 

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.

 

Break

Culture, Ethics and Compliance

Global Anti-Corruption Enforcement 

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

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.

 

Lunch Break

Antitrust Regulations in the Life Sciences Industry

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.

 

Break

Compliance Officers’ Panel Discussion

Networking Reception

Timo Cucina, Vila Olímpia

Avenida Presidente Juscelino Kubitschek, 1909, São Paulo

 

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.

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.

 

Lunch Break

Monitoring Programs

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

 

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.

 

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.

 

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.

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.

 

Interactive Team Case Study - Group Exercise

Lunch Break

Interactive Team Case Study - Group Exercise

Interactive Team Case Study

Closing remarks & Awarding of Program Certificates