Medical Devices International Trade Seminar Agenda

10:30

Regulatory framework for the Pacific Alliance countries

Alvaro Rincon, Director General, SPI, Bogota, Colombia 

11:00

Updates in Cofepris structure and operations in 20-21
Luisa Gutierrez, CEO, Medisi America, Mexico City, Mexico

11:30

How to do business in the Americas, from a regulatory, legal and tax perspective

Margarita Morales-Perez, CEO & President, Healthcare International Partners (HIP), Florida, USA

12:00

Latin America: opportunities and challenges of nearly 1/4 of the world’s hospitals

Guillaume Corpart, Founder & CEO, Global Health Intelligence, Florida, USA

12:15

Close of day one

13:00

FDA emergencyuse opportunities for medical device commercialization during the COVID-19 pandemic

Dallas L. Thomas, Medical Device Consultant for FDA, Regulatory and Compliance, Thomas Regulatory Resolutions, Florida, USA 

13:30

Importer and exporter obligations to FDA and CBP

Benjamin England, CEO, Co-Founder, Benjamin England & Associates, Maryland, USA

14:10

FDA marketing requirements for the import and distribution of medical devices

Amin Talati Wasserman 

14:40

Post-COVID: the road ahead for hospitals and medical equipment in Latin America

Guillaume Corpart, Founder & CEO, Global Health Intelligence,Florida, USA

15:20

A change is going to come: how to cope with the requirements of the EU Medical Device Regulation (MDR) in terms of changes and how to make the best out of its grace period?

Dr Isabelle Lang-Zwosta, Global Regulatory Affairs and Business Development Manager, Knoell, Tennessee, United States 

15:50

Close of day two

10:30

HIP – US focus

Margarita Morales-Perez, CEO & President, Healthcare International Partners (HIP), Florida, USA

11:00

The differences of importing a medical vs non-medical device

John Gargaro, President, RAF Solutions, Florida, USA

11:30

The regulatory affairs and quality management system challenges of artificial intelligence (AI) and their impact on medical device manufacturers

Louis-Paul Marin, CEO, LOK North America, Quebec, Canada 

12:30

Close of conference