Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry

Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry 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 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

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