Pharmaceutical Regulatory Affairs in Latin America In-house Training

Course overview

Explore and gain insights into the regulatory framework of the main authorities in key Latin America countries (Brazil, Mexico, Colombia, Chile, Argentina and Peru), crucial for navigating market entry requirements, ensuring compliance with local regulations, and managing pharmaceutical registrations across diverse markets.

Navigating the complex landscape of pharmaceutical regulatory requirements in Latin America is essential for ensuring successful market access and compliance. Unlike regions with standardized procedures, Latin America presents significant challenges due to the diverse and country-specific regulations governing sanitary registration. Each regulatory authority has its own set of rules, creating a formidable task for professionals seeking to bring pharmaceutical products to market.

This course is designed to address these challenges by providing participants with comprehensive insights into the regulatory frameworks of key Latin American countries. Participants will explore various approaches to obtaining marketing authorization and analyse the commonalities and differences among the region's most advanced regulatory authorities.

Throughout the training, participants will engage in in-depth case studies to explore options and strategies for fulfilling crucial regulatory activities. This interactive learning experience will provide opportunities to discuss and exchange experiences with our expert trainer and fellow delegates.

Key topics to be addressed:

• Pharmaceutical regulations in Latin America covering the following countries: Brazil, Mexico, Colombia, Argentina and Peru
• Regulatory strategies to grant the registrations and access to Latin America markets.
• Good interactions practices with Health Authorities of Latin America region
• Registrations procedures, renewals, and variations in all mentioned countries
• GMP inspections and stability studies

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

• Explore Latin America's regulatory landscape, registration processes, and recognition mechanisms.
• Understand varied pathways and strategies dictated by legislation based on the Certificate of Pharmaceutical Product and its compliance criteria.
• Gain insight into legislation regarding products demonstrating Therapeutic Equivalence, strategy design based on experience, and regulatory intelligence.
• Compare registration dossier structures covering legal, chemical/pharmaceutical, and clinical aspects.
• Utilise practical examples to formulate strategies with regulatory authorities.

Who should attend?

This seminar is especially valuable for professionals seeking to master the intricacies of successful marketing authorization applications and in-market regulatory compliance in the Latin American region. Whether you are new to this field or looking to refresh your knowledge, this seminar will provide essential insights and practical guidance.

• Regulatory Affairs Professionals
• Research and Development 
• Project Management
• Business Planning
• Business Management
• Manufacturers
• Quality Assurance/Quality Control
• Labelling and Artwork
• Pharmacovigilance