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

Future Events

Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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