The Center for Professional Innovation & Education, Malvern, PA
May 5 & 6, 2009
Who Should Attend
This course will benefit regulatory personnel whose responsibilities require knowledge of Latin America’s regulatory environment. Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant. Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.
Learning Objectives
This course is designed to provide an overview of the regulatory environment in Latin America and will provide training in: - What is the Regulatory Structure in Latin America (Primary Focus will be on Argentina, Brazil and Mexico)
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
- How to begin company involvement in Latin America ?
- How current regulations effect product development strategies
- Pricing issues
- Understanding the concerns/issues of Latin American Regulatory Personnel
- Understanding the Local Culture: How to negotiate with the regulators
- Information necessary for effective submissions
- Strategies for streamlining the registration application process for faster approval
- Maintenance of Authorized Products
Course Description
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, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. 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 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 regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts that arise and the best approach for resolution.
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