2019 - Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

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