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Regulatory Affairs in Latin America

23 - 24 April 2018

Radisson Blu Edwardian Kenilworth, London

With so many varying requirements across Latin America, navigating the regulations can be difficult and time consuming. This 2-day course will take you through the process of compiling the dossier, clinical trials, commercial landscape and pharmacovigilance in each country so you have the skills and confidence to operate in the region. 

Countries discussed: Brazil | Mexico | Argentina | Columbia | Venezuela | Chile | Peru | Ecuador | Paraguay

  • Explore the structure and function of key regulatory authorities
  • Examine registration processes including data requirements and dossier formats
  • Enhance registration strategies for pharmaceuticals and biotech, including generics and biosimilars
  • Learn how to manage regulatory developments in the region
  • Gain a critical overview of the healthcare system and local laws for pharmaceuticals

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:

  • Regulatory Affairs Specialist
  • Regional Coordinator
  • Regulatory Affairs Associate
  • Development Pharmacist
  • Pharmacovigiliance Manager
  • Regulatory Affairs Attorney
  • Regulatory Affairs Executive
  • Project Managers
  • Regulatory Affairs Manager
  • Strategy Management
  • Regulatory Affairs Officer
  • Quality Manager

The trainer's attitude and knowledge was excellent.

Regulatory Submissions Manager, LEO Pharma


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.

Submissions Manager, LEO Pharma


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