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Regulatory Affairs in Latin America for Medical Devices

23 - 24 September 2020

Radisson Blu Edwardian Kenilworth, London

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 intense 2-day 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

  • 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
  • Examine lifecycle management, such as variation and renewal procedures to effectively manage your device post approval
  • Explore the ANVISA GMP audit and the IMDRF scheme to eradicate this lengthy procedure
  • Understand the importance of having local contacts in the region and evaluate the ‘pros’ and ‘cons’ of using distributors and host companies

MARÍA DE LA LUZ LARA MÉNDEZ

Maria is the CEO of a regulatory affairs consultant for ICON where she covers Central America and Latin America, and holds 15 years experience in Regulatory affairs in private and public sectors. Having worked at the National Regulatory Agency of Mexico (COFEPRIS) for over 10 years in various director level positions, Maria has had a key role in the development of official standards, regarding Biotechnological products and pharmacovigilance, and has acted as a COFEPRIS representative at various international forums such as, the Pacific Alliance, International Pharmaceutical Regulators Forum (IPRF) and The International Generic Drug Regulators Pilot (IGDRP).

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.

We're looking forward to welcoming our attendees and expert course leaders at Regulatory Affairs in Latin America for Medical Devices.

Our number one priority is the safety of our delegates and colleagues, and there are always measures in place at our venues to safeguard your health and safety. There are extra measures in place for 2020 in light of developments with COVID-19.

Book with total confidence – click here to be fully assured on how your booking rights are protected.

Medical devices software development and applications

Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 

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