Latin America’s Regulatory Structure for the Life Science Product Industries

• Regulatory Framework: Key Agencies Involved / Reporting Structure
• Pharmaceuticals
• Medical Devices
• Biologics
• Combination Products

Tense and Voice in Process Documents

• Identifying the audience
• Using verbs to control action 
• Using the active voice
• Paring the passive
• Writing in the third person
• Using the imperative voice

Beginning Your Company Involvement in Latin America

• Local Office and Personnel Requirements
• Language Requirements

Objectives of the Rules Governing Medicinal Procedures

Life Science Regulations and the Regulatory Processes in Latin America

• Pre-Clinical
• Conducting Clinical Trials
• New Product Registrations & Filings
• Post-Marketing Requirements
• Maintenance of Licensed Products

Latin America’s Use of ICH Standards / Principles

• GCP
• GMP
• Quality Documents and Standards
• CTD / e-CTD Submissions

Starting-Up and Conducting Clinical Trials Approvals

• CRO Use in Latin America
• Clinical Trials vs. Clinical Investigations
• Labeling Requirements

• Drug vs. Medical Device vs. Biologic vs. Combination Product
• Drug Master File (DMF) Use in Latin America
• Similar Products & Devices
• Use of Expert Reports
• Labeling Requirements
• Processing Variations on Licensed Products

Variations: Changes to Marketed Products

• Types of Variations
• Dossier Maintenance Expectations
• Changes Concerning Manufacturing Aspects (Product & Process)
• Labeling & Packaging Leaflet Requirements

Comparing and Contrasting Latin American Procedures vs. the U.S. FDA

• Comparison of Processes
• Agency Interactions
• Accepted Practices

How and When to Influence the Regulatory Process Accepted Country Practices

• Effective Monitoring Activity
• Association vs. Individual Company Involvement & Intervention
• The Regulatory Negotiation Process
• Effective Approaches
• The Do’s and Don’ts of Regulatory Involvement

How to Use Regulations / Regulatory Contacts to Your Advantage

• Check-in Procedure
• Agency Interactions
• Business Impact Within and Outside Latin America
• Professionalism in Regulatory Lobbying

Case Studies

Class Exercises

Resources / Helpful Websites