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
Virginie Rivas has over 15 years’ experience within quality, regulatory affairs and clinical for various international pharmaceutical groups. She has successfully registered various pharmaceutical products such as vaccines, drugs, medical devices of all classes, cosmetics and dietary supplements in more than 80 countries but with significant expertise acquired and recognised in Latin America.
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.