LIVE Online Course | 12pm - 5pm GMT
UNDERSTAND AND ADHERE TO THE LATAM REGULATORY LANDSCAPE FOR ACCELERATED DEVICE APPROVAL AND LIFETIME COMPLIANCE
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Dates for the 2026 course are yet to be announced, but you can express your interest, and we will notify you as soon as registration opens.
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2025 Course Trainers: Top Regulatory Affairs Industry Experts Sharing Their Expertise
2025 Agenda At A Glance
Overview
This online course will help you understand and adhere to the LATAM regulatory landscape.
From dossier preparation and classification to lifecycle management and labelling, explore the key issues in the region and gain insights into how to get your device approved.
- Discover mutual recognition agreements and harmonisation in the region for a simplified approval process in multiple countries
- Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices
- Learn about future regulatory developments in the region
Framework
Designed for experienced regulatory professionals who are either new to operations in Latin America or are already working in the region and want to further increase their knowledge.
We’ll provide an in-depth analysis of key markets like Brazil, Mexico, and Argentina, while also tackling the regulatory challenges in Colombia, Chile, Peru, Ecuador, Paraguay, and Costa Rica.
- Live online sessions
- Interactive features, including Q&A, break out room, exercises and case studies
- Interaction with peers during live sessions and through the online forum
Key Lessons from the 2025 Course:
Existing mutual recognition agreements
Discover mutual recognition agreements and harmonisation in the region for a simplified approval process in multiple countries
Dossier requirements
Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices
Key developments
Learn about future regulatory developments in the region
Lifecycle management
Examine lifecycle management, such as variation and renewal procedures to effectively manage your device post approval
ANVISA GMP audits
Explore the ANVISA GMP audit and the IMDRF scheme to eradicate this lengthy procedure
Forming local partnerships
Understand the importance of having local contacts in the region and evaluate the ‘pros’ and ‘cons’ of using distributors and host companies