Understanding Regulatory Compliance Requirements Across Life Science Industry (Medical Devices Trai)
|Event Date/Time: Aug 26, 2011||End Date/Time: Aug 26, 2011|
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 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, which arise and the best course for resolution.
Areas Covered in the Seminar:
Glossary of Terms.
Defining the Opportunity.
Country Facts: Argentina, Brazil, Mexico.
Latin America's Regulatory Structure for the Life Science Product Industries
Mercosur - Southern Common Market.
Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
Registration / Required Country Licenses.