Event Detail
Latin America – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Biotech and Medical Devices
September 29 - 30, 2009
- Online Not Applicable
BenAstrum Pharma Broad
ardy.heydari@benastrum.com
Phone: (514) 337-1616
Fax: (514) 337-8803
2-Session Live Web Training Course: Session 1: Tuesday, September 29, 2009 Session 2: Wednesday, September 30, 2009 Instructor: Robert J. Russell Learning Objectives of 2-Session Series: 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