FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course Marketing Authorisation in Latin America
Marketing Authorisation
in Latin America
2018-12-23 2019-09-24 NH Frankfurt Airport West Kelsterbacher Str. 19-21 65479 Frankfurt-Raunheim +49 6142 990-0 +49 6142 990-100

Marketing Authorisation in Latin America

Focus on: Brazil, Mexico, Argentina, Colombia, Peru & Chile

A course to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.
  • LATAM - regulatory environment and harmonisation trends
  • National procedures in Brazil, Mexico, Argentina, Colombia, Peru & Chile
  • Dossier requirements for NCEs and generics
  • Maintenance: variations and renewal

This distinguishes our event

Overall impression: 100 % of the participants' feedback was very good or good (September 2018)
Course content: 100 % of the participants' feedback was very good or good (September 2018)
Practical benefit: 100% of the participants' feedback was very good or good (September 2018)

Aims and objectives

What are the key success factors in introducing your products in the LATAM region? What do you have to keep in mind when applying for a marketing authorisation in these countries?

This workshop will enable you to answer these questions and will provide deep insights into the regulatory environments of the various markets.

Two LATAM experts will share valuable information regarding:
  • dossier requirements,
  • marketing authorisation procedures and
  • maintenance duties.

In interactive sessions, you will learn about key challenges for each market and will also be given the chance to discuss your own cases. Thus, you will gain better understanding of the regulatory affairs business in the LATAM region.

Who should attend
This seminar will be of benefit to all those working in the pharmaceutical industry, particularly in regulatory affairs and business development, who are interested in marketing pharmaceuticals in Latin America.
The seminar will focus on human medicinal products (chemicals and biologics; herbals will not be addressed).
Your speakers
Esther Gil López
PAREXEL Consulting, Madrid, ESPANIA

Anita Patel
PAREXEL Consulting, São Paulo, BRAZIL

Go forward

Pharma Webcast Global RA & PV

Pharma FORUM Webcast International

We would like to invite you to join our live webcasts, where local regulatory affairs and vigilance experts will inform you every two months of the latest news and trends in global marketing authorisation and drug safety.



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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).