Marketing Authorisation in Latin America

Focused insights on regulatory strategies in Brazil, Mexico, Peru, Colombia, Chile and Argentina

  • Local experts for firsthand information
  • Fast-track options and reliance strategies
  • Key dossier requirements and regulatory procedures
  • Officially certificated ISO 9001 and ISO 21001
Marketing Authorisation 
in Latin America

Online-Seminar

From 1.990,00 € plus VAT
Services & Process

Booking details

Online-Seminar

From 1.990,00 € plus VAT
Services & Process

An interactive online seminar to explore real regulatory cases and challenges in marketing authorisation and lifecycle management across Mexico, Argentina, Colombia, Peru, Chile and Brazil - led by local experts from Brazil and Peru.

Your speakers

Anita Patel

Anita Patel

Pharmacist and Biochemist,
Regulatory Affairs Director,
Parexel International, São Paulo, BRAZIL

Pharmacist and Biochemist,
Regulatory Affairs Director

With over 20 years of experience in the pharma…

Bertha Cabrera Lavado

Bertha Cabrera Lavado

Parxel International, Lima, PERU

Associate Director, Regulatory Affairs; With more than 14 years of hands-on experience in the regulatory field within a Contract Research Organisation (CRO), Bertha…

What to Expect

  • LATAM pharmaceutical landscape: market potential, harmonisation trends and regional dossier formats
  • National procedures and updates
  • Dossier requirements for NCEs, generics and orphan drugs
  • Lifecycle management: variations, renewals, labelling and inspection readiness
  • Fast-track initiatives, digitalisation, reliance models and mutual recognition
  • Case-based learning: practical exercises, country-specific challenges and cross-country strategy

Who Should Attend

This online seminar is designed for professionals working in Regulatory Affairs and related departments who are involved in marketing authorisation and product maintenance for Latin American markets.

The seminar will focus on human medicinal products (chemicals and biologics; herbals will not be addressed).

Basic understanding in regulatory affairs is required.

Objective of the Event

What are the key success factors in introducing your products in the LATAM region? What do you need to consider when applying for marketing authorisation in countries such as Brazil, Mexico, Argentina or Peru?
This online seminar will equip you with the knowledge to answer these questions.

Two seasoned LATAM experts will guide you through the region’s complex regulatory landscape, offering first-hand insights into dossier requirements, authorisation procedures and maintenance duties.
Through interactive case studies and group discussions, you will explore market-specific challenges and receive practical tools for your day-to-day regulatory work. You will also benefit from expert tips on fast-track options, reliance strategies and dossier format differences.

The combination of theoretical input and practical application ensures a deep understanding of the regulatory affairs business in Latin America - empowering you to develop more effective market access strategies.

Your Benefit

  • Meet experts with local know-how and firsthand experience
  • Gain deep insights into Brazilian, Mexican, Colombian and Argentinian markets
  • Understand key dossier requirements and regulatory procedures
  • Learn how to navigate fast-track options and reliance strategies
  • Discuss real-world cases and bring your own challenges
  • Strengthen your LATAM regulatory strategy with practical tools

Programme

from 10:00 - 18:00 on both days,
You may dial in 30 min. before the session

Day 1

Welcome and introductions
Anita Patel
  • Participant ice-breaker: Experience in LatAm registrations
  • Objectives and seminar overview

Latin American pharmaceutical landscape: Market insights and regulatory environment
Anita Patel
  • Market potential: Mercosur, Pacific Alliance
  • Harmonisation trends: AMLAC, ICH alignment, reliance pathways
  • Overview of common dossier formats: CTD, eCTD, local adaptations
  • Insights on smaller markets: Central America, Ecuador, Uruguay, etc.
  • Fastest approval process?

Brazil: Marketing authorisation and lifecycle management
Anita Patel
  • ANVISA procedures and updates
  • Dossier requirements: NCEs, generics, biologics, biosimilars
  • Orphan drug procedures and reliance opportunities
  • Maintenance: Variations, renewals, labelling
  • Overview for ANVISA inspections

Practical exercise: Case study for Brazil
Bertha Cabrera Lavado, Anita Patel
  • Interactive scenario discussion

Mexico: Marketing authorisation and lifecycle management
Bertha Cabrera Lavado
  • COFEPRIS procedures and recent reforms
  • Dossier requirements: NCEs, generics, biologics, biosimilars
  • Orphan drug procedures and reliance opportunities
  • Maintenance: Variations, renewals, labelling
  • Fast-track initiatives and digitalisation

Practical exercise: Case study for Mexico
  • Interactive scenario discussion

Peru: Marketing authorisation and lifecycle management
Bertha Cabrera Lavado
  • DIGEMID procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Peru

Interactive scenario discussion

Welcome and introductions

Anita Patel

  • Participant ice-breaker: Experience in LatAm registrations
  • Objectives and seminar overview

Latin American pharmaceutical landscape: Market insights and regulatory environment

Anita Patel

  • Market potential: Mercosur, Pacific Alliance
  • Harmonisation trends: AMLAC, ICH alignment, reliance pathways
  • Overview of common dossier formats: CTD, eCTD, local adaptations
  • Insights on smaller markets: Central America, Ecuador, Uruguay, etc.
  • Fastest approval process?

Brazil: Marketing authorisation and lifecycle management

Anita Patel

  • ANVISA procedures and updates
  • Dossier requirements: NCEs, generics, biologics, biosimilars
  • Orphan drug procedures and reliance opportunities
  • Maintenance: Variations, renewals, labelling
  • Overview for ANVISA inspections

Practical exercise: Case study for Brazil

Bertha Cabrera Lavado, Anita Patel

  • Interactive scenario discussion

Mexico: Marketing authorisation and lifecycle management

Bertha Cabrera Lavado

  • COFEPRIS procedures and recent reforms
  • Dossier requirements: NCEs, generics, biologics, biosimilars
  • Orphan drug procedures and reliance opportunities
  • Maintenance: Variations, renewals, labelling
  • Fast-track initiatives and digitalisation

Practical exercise: Case study for Mexico

  • Interactive scenario discussion

Peru: Marketing authorisation and lifecycle management

Bertha Cabrera Lavado

  • DIGEMID procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Peru

Interactive scenario discussion

Day 2

Day 2
Anita Patel
  • Key Takeaways & Open Questions from Day 1

Colombia: Marketing authorisation and lifecycle management
Anita Patel
  • INVIMA procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Colombia
  • Interactive scenario discussion

Chile: Marketing authorisation and lifecycle management
Anita Patel
  • ISP procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Chile
  • Interactive scenario discussion

Argentina: Marketing authorisation and lifecycle management
Bertha Cabrera Lavado
  • ANMAT procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Fast-track routes and regulatory simplifications
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Argentina
  • Interactive scenario discussion

Cross-country comparison and strategy session
Bertha Cabrera Lavado, Anita Patel
  • Comparative recap: Approval timelines, dossier formats, renewal periods
  • Multi-country filing strategies and mutual recognition

Take Home Messages
Bertha Cabrera Lavado, Anita Patel

Expert panel: Live Q&A session
Bertha Cabrera Lavado, Anita Patel

Day 2

Anita Patel

  • Key Takeaways & Open Questions from Day 1

Colombia: Marketing authorisation and lifecycle management

Anita Patel

  • INVIMA procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Colombia

  • Interactive scenario discussion

Chile: Marketing authorisation and lifecycle management

Anita Patel

  • ISP procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Chile

  • Interactive scenario discussion

Argentina: Marketing authorisation and lifecycle management

Bertha Cabrera Lavado

  • ANMAT procedures and dossier specifics
  • Dossier requirements: NCEs, generics, biologics, orphan drugs
  • Fast-track routes and regulatory simplifications
  • Maintenance: Variations, renewals, labelling

Practical exercise: Case study for Argentina

  • Interactive scenario discussion

Cross-country comparison and strategy session

Bertha Cabrera Lavado, Anita Patel

  • Comparative recap: Approval timelines, dossier formats, renewal periods
  • Multi-country filing strategies and mutual recognition

Take Home Messages

Expert panel: Live Q&A session

Your options:

Are you interested in an in-house training course on topic "Marketing Authorisation
in Latin America"?
Please contact us to find out more.
Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional EU and/or global regulatory affairs online trainings.

Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager

By booking the qualification course you will save up to 30% compared to individual bookings.

Downloads

Request the documents using our form.

Prospekt

Brochure

Abbreviation List: Drug Regulatory Affairs / CMC

Further Informations


Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.


Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.


Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.


Looking to train several employees on this topic?

We offer customised in-house training!
Take advantage of our proven seminar concepts and ensure your team reaches a unified level of knowledge quickly and efficiently.
We’d be happy to provide you with a non-binding offer.

Please contact Verena Planitz (v.planitz@forum-institut.de) for more information!

This is what distinguishes this event

Overall impression: 100 % of the participants' feedback was very good or good (September 2022)

Course content: 100 % of the participants' feedback was very good or good (September 2022)

In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

Customer Testimonials

What satisfied participants say

"This seminar deals with regulatory aspects in Latin American countries. The seminar is conducted by very experienced speakers from Spain and Brazil. There are practical activities that enable you to deepen the knowledge you have acquired. The seminar left a very positive impression in terms of the knowledge imparted and the technical competence of the speakers."

"Both speakers were great!"

"I wanted to get a comprehensive overview of the regulatory issues in Latin American countries. The seminar exceeded my expectations"

"Brazil requirements very helpful"

"The speakers did a very good Job; I expected an overview about the regulations and specific issues, and I get one."

"Specific questions relating to Brazil - expectation met"

"Very useful, appropriate to get an overview on the regulatory environment in LATAM countries"

"Overview on regulatory matters in LATAM - expectation met"

"The presentations were clear and very well structured and also the lessons learned"

"Very informative"

Dr. Evgeny Levin Eckert & Ziegler Radiopharma GmbH

"I found everything informativ. Very good documentation. Answers to our questions"

"Very good! "

Alessandra Testini Adare Pharmaceuticals Srl

"Expectation to learn the basics about regulatory requirements in LATAM countries was met"

"To learn more about Latin America Regulations - all was met"

"Two days with much information aand good documentation. A good size of group of 7"

"Have a summary of requirements in LATAM. My expectations has been met"

"Divevsity of country regulators & environments. "

"Very sympatic referents"

"My expectations were met. General information about LATAM region submissions and detailled information on specific countries"

"Good to learn the basics for LATIN America RA"

"Pracitcal examples "

"Very good knowledge of the speakers"

"Perfect discussion, very good structure, additional information was provided. "

"Clean presentations for all countries answering all questions and giving good advice for working in this region. The content is very insightful and the speakers muster and cover all needed informations and answer all questions. Excellent content - Helpful advice. "

"Very important + supportive. Very informative. "

"Professional, friendly, to the point. No hurry, enough time to ask + explain or clasify. "

"Professional speakers, nice atmosphere, very informative"

"Very good seminar, highly recommended. Interesting content, well structured and very good communicated."

"The good atmosphere and open communication what allowed all participants to have good and interessting discussions. The speakers answered all questions very focused and in a very professional way. "

Our Recommendations

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Further Information

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We guarantee the highest quality

We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Verena Planitz

Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de