Latin America Understanding Regulatory Compliance Requirements Across the Life Science Industry 2019 is a webinar that covers topics such as:
- Defining the Opportunity
- Glossary of Terms
- Latin America`s Regulatory Structure for the Life Science Product Industries
- 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
Latin America Understanding Regulatory Compliance Requirements Across the Life Science Industry 2019 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