DUBLIN–(BUSINESS WIRE)–Jul 31, 2020–
The “Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry (Focus: Brazil, Mexico, Argentina)” training has been added to ResearchAndMarkets.com‘s offering.
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 Should You Attend:
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, IVDs, Biologics, Biosimilars, Orphan Drugs, and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru, and Venezuela will be discussed. 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.
Key Topics Covered:
Day 01 (10:00 AM – 4:00 PM EDT)
- 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
- Marketing Authorization Processes
- Generic Products & Bioequivalence Testing
- Biologics & Biosimilars
- Orphan Drug Special Processes
- Compassionate Use/Special Access
- Medical Device Registrations & Product Licenses
- Device Classifications
- 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
- 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
- Resources/Helpful Websites.
For more information about this training visit https://www.researchandmarkets.com/r/xupvn2
View source version on businesswire.com:https://www.businesswire.com/news/home/20200731005249/en/
Laura Wood, Senior Press Manager
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INDUSTRY KEYWORD: PHARMACEUTICAL LEGAL PROFESSIONAL SERVICES HEALTH
SOURCE: Research and Markets
Copyright Business Wire 2020.
PUB: 07/31/2020 07:41 AM/DISC: 07/31/2020 07:41 AM
Copyright Business Wire 2020.