Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

Topics

• Latin America`s Regulatory Structure for the Life Science Product Industries
• Defining the Opportunity
• Glossary of Terms
• Country Facts: Argentina, Brazil, Mexico
• Beginning Your Company Involvement in Latin America: Examples of Country Requirements
• Mercosur - Southern Common Market
• Common Fees
• Registration / Required Country Licenses
• Marketing Authorization Processes - Filings & Registrations
• Overview of the Rules Governing Medicinal Products & Medical Devices
• Use of Expert Reports
• Drug Master File (DMF) Use in Latin America Registrations
• Labeling & Packaging Leaflet Requirements
• Processing Variations on Licensed Products
• Comparing and Contrasting Latin American Procedures vs. the U.S. FDA
• Orphan Drugs / Rare Diseases
• The Regulatory Negotiation Process
• How and When to Influence the Regulatory Process
• Resources / Helpful Websites
• How to Use Regulations / Regulatory Contacts to Your Advantage

Who should Attend

• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant
• Regulatory personnel whose responsibilities require knowledge of Latin America`s regulatory environment
• Global Supply Chain personnel
• QA / QC Personnel
• Manufacturing personnel
• Clinical / Pharma & Device personnel
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit
• Global Business Development personnel