Overview:
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings, and knowing how to navigate the regulatory landscape will accelerate the country's establishment and successful product licensing.
Why you should 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 to 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 Session:
- 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 into Operations
- Mexico - COFEPRIS Structure & Insight into Operations
- Argentina - ANMAT Structure & Insight into 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
Who Will Benefit:
- Regulatory Personnel whose responsibilities require knowledge of Latin America's regulatory environment
- Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant
- QA / QC Personnel
- Global Supply Chain Personnel
- Clinical / Pharma & Device Personnel
- Manufacturing Personnel
- Global Business Development Personnel
- Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit