Why Should You Attend:
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating to full product life-cycle management, as well as, address the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.
Areas Covered in the Webinar:
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.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating to full product life-cycle management, as well as, address the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.
Areas Covered in the Webinar:
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.
