Pharmaceutical Regulatory Affairs in Latin America

Regulatory requirements for the Pharmaceutical Markets across Latin America including Columbia, Peru, Brazil, Mexico, Argentina, Uruguay, Paraguay, Venezuela, Ecuador, Central America, Chile

This seminar can be viewed both as an Introductory and a Refresher course and will provide you with:-

• An up-to date coverage of the requirements that underpin successful marketing authorisation appliations for pharmaceutical products across Latin America
• The official regulatory information
• Interpretation and alternatives to local and specific legal requirements
• Hands-on experience in the region
• An overview of the regulatory aspects of site inspections
• Requirements for the marketing of NCE, Biologic and biotechnology products, generic drugs and OTC medicines

A comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin American countries

The following topics will be covered during the 3 days

• Latin American demographics and market characteristics
• Current legislation for key LA countries
• Product Marketing Authorisation Requirements
• Marketing Authorisation Modifications
• Stability Requirements
• Packaging and Labelling
• Advertising regulations
• Bioequivalence
• Biologic and biotechnology product regulations