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Regulatory Affairs in Latin America

25 - 28 August 2020

New LIVE Online Academy


In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. 

Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact [email protected].

For more information and a comparison with other digital study modes, download the digital training guide.

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 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 

  • 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


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).

Iván Calderon

Iván is a pharmacist who graduated from UNAM, where he was also awarded a master's degree for his studies focused on nanotechnology and unconventional routes of administration.

Iván has worked for the pharmaceutical industry in inspections for the compliance of GMPs in the Republic of China with producers of active ingredients (APIs). He has collaborated in the field of clinical studies, focused on bioequivalence and collaborated as an academic.

Iván has worked for the Mexican regulatory agency, has been a member of the Controlled Release Society (CRS) and recently of The Association for Clinical Research Professionals (ACRP); he has participated in international initiatives such as the International Generic Drug Regulators Pilot (IGDRP), the International Pharmaceutical Regulators Forum (IPRF), Dengue Vaccine Initiative (DVI) and in the International Regulatory Cooperation for Herbal Medicines (IRCH).

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

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

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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