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Informa
Starting TBC in 2021

LIVE Online Course - 7 sessions

Develop your understanding of the regulatory landscape in Latin America to ensure fast device registration

Course Overview

With the medical device markets in Latin America estimated to be worth $11 billion and growing, it is essential for regulatory professionals to understand the local regulations and requirements for fast market access. Journeying from country to country in the region, this course explores the key issues in Latin America from dossier preparation and classification to lifecycle management and labelling so you have the required skills to get your device approved.

As well as learning about the fundamentals of local regulations the course will also develop best practiced strategies to manage important relationships and import your devices, which can cause significant problems if overlooked.

Main focus: Brazil, Mexico and Argentina

Also discussed: Colombia, Venezuela, Chile, Peru, Ecuador, Paraguay and Costa Rica

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.

Over 2 weeks students will learn through:

  • Live interactive bitesize sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Existing mutual recognition agreements
Existing mutual recognition agreements

Discover mutual recognition agreements and harmonisation in the region for a simplified approval process in multiple countries

Dossier requirements
Dossier requirements

Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices

Key developments
Key developments

Learn about future regulatory developments in the region


Lifecycle management
Lifecycle management

Examine lifecycle management, such as variation and renewal procedures to effectively manage your device post approval

ANVISA GMP audits
ANVISA GMP audits

Explore the ANVISA GMP audit and the IMDRF scheme to eradicate this lengthy procedure

Forming local partnerships
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

Who is this course for?

This course has been 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.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Delegates of our live online academies said...

94%
would attend another live online academy
97%
found the course beneficial to their day to day role
97%
would recommend the course to others

25% discount on Routledge books

As a student on the course, you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.

Examples of books and eBooks within medical devices include:

  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Instruments and Devices: Principles and Practices
  • Design Controls for the Medical Device Industry, Third Edition
  • Medical Device Regulatory Practices: An International Perspective
  • Handbook of Medical Device Regulatory Affairs in Asia: Second Edition
  • And more