Pharmaceutical Regulatory Affairs in Latin America 2017

Topics

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

Who should Attend

• Registration Departments
• Regulatory Affairs
• Analytical Research and Development
• Medical Directors
• New Business Development Departments
• Quality Assurance
• Regulatory Authorities