Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico 2017 is a webinar that covers topics such as:
- 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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico 2017 is intended for:
- 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