Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.
Why Should You Attend: 

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed.

The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of the wide array of licensed products.

The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other National Healthcare Authorities. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.
Areas Covered In The Session: 

- LA Overview
- LA markets
- Harmonization efforts
- Understanding the Regulatory Process
- Regulatory Overview (gov't offices, organization, contact info)
- Country Establishment
- Scientific advice
- Stability studies
- Submission Process
- Paper filings
- Electronic filings
- Generics & Bioequivalence
- Compassionate use
- Orphan drugs
- Combination products
- Patents/Copyrights/Trademarks
- Import/Export procedures
- Tax exemptions
- Advertising/Promotion
- Comparing & Contrasting LA and US
- Challenges in Latin America
- Influencing the Regulatory Process
- Conclusions & summary

Learning Objectives: 

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed.

The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of the wide array of licensed products.