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Live Online Training Course Running 2-3 April 2025

LIVE Online Course | 12pm - 5pm GMT

Live Online Training Course Running 2-3 April 2025

LIVE Online Course | 12pm - 5pm GMT

UNDERSTAND AND ADHERE TO THE LATAM REGULATORY LANDSCAPE FOR ACCELERATED DEVICE APPROVAL AND LIFETIME COMPLIANCE

Course 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

What Will You Learn?

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