Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico 2017

Topics

• Defining the Opportunity: Overview of Latin America
• Glossary of Terms
• Latin America`s Regulatory Structure for the Life Science Product Industries
• Country Facts: Argentina, Brazil, Mexico
• Mexico – COFEPRIS Structure & Insight to Operations
• Brazil – ANVISA Structure & Insight to Operations
• Mercosur - Southern Common Market
• Argentina – ANMAT Structure & Insight to Operations
• Beginning Your Company Involvement in Latin America: Examples of Country Requirements
• Harmonization Efforts
• Common Fees
• Registration / Required Country Licenses
• Clinical Trials, GCP: When are they needed?
• Overview of the Rules Governing Medicinal Products & Medical Devices
• Stability Studies: Zonal Unique Requirements
• GMP Compliance
• CTD Format Transition
• Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
• Package Inserts
• Summary of Product Characteristics
• Amendments / Variations / Renewals
• Labeling Requirements
• Medical Device Registrations & Product Licenses
• Marketing Authorization Processes
• Amendments / Variations
• Device Classifications
• Drug / Device Master File (DMF): Use in Latin America
• Device Renewal Applications
• Labeling & Packaging Leaflet Requirements
• Processing Variations on Licensed Products
• Import / Export Procedures
• Drug / Device Vigilance & Post-Marketing Responsibilities
• Advertising & Promotion of Products
• Patents / Copyrights / Trademarks
• The Regulatory Negotiation Process
• How and When to Influence the Regulatory Process
• Recent Country Legislation: New Regulations
• How to Use Regulations / Regulatory Contacts to Your Advantage
• Resources / Helpful Websites
• Conclusions

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