The market opportunity in Latin America is growing considerably thanks to increased life expectancies which have prompted a rise in government spending on healthcare. Countries such as Brazil, Argentina and Mexico are set to grow at a faster rate year on year than those in Europe, making the region a target for the (bio)pharmaceutical sector. With so many varying requirements and approval procedures across Latin America, navigating the regulations can be difficult and time consuming.
This 2-day course will take you through the key regulatory requirements and procedures such as compiling the dossier, clinical trials, commercial landscape and pharmacovigilance in each country so you have the skills and confidence to operate in the region. You will discover how to process pharmaceuticals including generics and biotech including biosimilars.
Countries discussed: Brazil | Mexico | Argentina | Colombia | Venezuela | Chile | Peru | Ecuador | Paraguay
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. She is a Professor of Regulatory Health Products for several faculties – Faculty of Pharmacy of Lillen – Faculty of Law, St Etienne.
Anyone working within the field of regulatory affairs at management level or above who want to gain an insight into the Regulatory landscape in Latin America, such as:
We're looking forward to welcoming our attendees and expert course leaders at Regulatory Affairs in Latin America in London in April.
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The trainer's attitude and knowledge was excellent.
The overview of Latin America was great. I actually took this course to learn more about the registration process in Mexico specifically. Good course content overall.