Event Detail
Latin America – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Biotech and Medical Device Indus
March 15 - 22, 2010
- Live Webinar CANADA
BenAstrum
2-Session Live Web Training: Session 1: Monday, March 15, 2010 Session 2: Monday, March 22, 2010 (9:20 a.m. - 11:30 a.m. EST) (8:20 a.m. - 10:30 a.m. CST) (6:20 a.m. - 8:30 a.m. PST) Instructor: Robert J. Russell Learning Objectives: This course is designed to provide an overview of the regulatory environment in Latin America and will provide training in: * The regulatory structure in Latin America (primary focus will be on the following countries: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela) * 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 to streamline the registration application process for faster approval * Maintenance of authorized products