Dublin, August 09, 2021 (GLOBE NEWSWIRE) – The course “Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)” has been added to ResearchAndMarkets.com offer.
The Latin America Regulatory Compliance Requirements Training / Webinar will cover topics throughout the business and product licensing lifecycle in key Latin American markets. Written regulations and skillful negotiation will be explained on each critical topic.
The importance of local resources, agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and product licensing success.
Why should you attend
This course focuses specifically on general regulatory compliance requirements and procedures for pharmaceuticals, medical devices, IVDs, biologics, biosimilars, orphan drugs and combination products in Latin America. The main countries covered will include: Argentina, Brazil and Mexico. Other countries like Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed.
The course will cover topics related to full product lifecycle management, as well as the structure of regulatory agencies in Latin America. The content will include descriptions of the methods by which the regulators of the corresponding agencies process filings and registrations and what is expected in the authorization and maintenance of records 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 science companies in the region are described.
Course content will explain how Latin America interacts and uses the ICH standards and how they relate to other national regulatory bodies. In addition, participants will learn how staff can best manage conflicts that arise and the best way to resolve them.
October 6, 2021 (11:00 a.m. – 5:00 p.m. EDT)
- Glossary of terms
- Defining the Opportunity: A Snapshot of Latin America
- Country Facts: Argentina, Brazil, Mexico
- Latin America’s regulatory structure for the life science products industries
- Brazil – ANVISA Structure & Insight to Operations
- Mexico – COFEPRIS Structure & Insight to Operations
- Argentina – ANMAT structure and overview of operations
- Mercosur – Southern Common Market
- Harmonization efforts
- Beginning of your company’s involvement in Latin America: examples of national requirements
- Registration / National licenses required
- Common costs
- Overview of the rules governing medicinal products and medical devices
- Clinical trials, GCP: when are they needed?
- GMP compliance
- Stability studies: unique zonal requirements
- Marketing authorization process and dossier requirements: pharmaceuticals
- CTD format transition
- Summary of product characteristics
- Packing instructions
- Labeling requirements
- Modifications / Variations / Renewals
- Marketing authorization process
- Generic products and bioequivalence tests
- Biologics and biosimilars
- Special processes for orphan drugs
- Compassionate use / Special access
- Medical device registrations and product licenses
- Device classifications
- Modifications / Variations
- Device renewal requests
- Drug / Device Master File (DMF): Use in Latin America
- Changes in the treatment of licensed products
- Requirements for labeling and packaging inserts
- Medication / device vigilance and post-market responsibilities
- Import / export procedures
- Patents / Copyrights / Trademarks
- Advertising and 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 national legislation: new regulations
- Useful Resources / Websites
For more information on this training, visit https://www.researchandmarkets.com/r/ssmvcw