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

Online-Seminar
Ab
1.990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Buchungsdetails
Online-Seminar
Ab
1.990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
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
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
Anita Patel
- Participant ice-breaker: Experience in LatAm registrations
- Objectives and seminar overview
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?
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
Bertha Cabrera Lavado, Anita Patel
- Interactive scenario discussion
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
- Interactive scenario discussion
Bertha Cabrera Lavado
- DIGEMID procedures and dossier specifics
- Dossier requirements: NCEs, generics, biologics, orphan drugs
- Maintenance: Variations, renewals, labelling
Interactive scenario discussion
Welcome and introductions
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
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
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
Practical exercise: Case study for Brazil
Bertha Cabrera Lavado, Anita Patel
- Interactive scenario discussion
Mexico: Marketing authorisation and lifecycle management
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
Practical exercise: Case study for Mexico
- Interactive scenario discussion
Peru: Marketing authorisation and lifecycle management
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
Practical exercise: Case study for Peru
Interactive scenario discussion
Day 2
Anita Patel
- Key Takeaways & Open Questions from Day 1
Anita Patel
- INVIMA procedures and dossier specifics
- Dossier requirements: NCEs, generics, biologics, orphan drugs
- Maintenance: Variations, renewals, labelling
- Interactive scenario discussion
Anita Patel
- ISP procedures and dossier specifics
- Dossier requirements: NCEs, generics, biologics, orphan drugs
- Maintenance: Variations, renewals, labelling
- Interactive scenario discussion
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
- Interactive scenario discussion
Bertha Cabrera Lavado, Anita Patel
- Comparative recap: Approval timelines, dossier formats, renewal periods
- Multi-country filing strategies and mutual recognition
Bertha Cabrera Lavado, Anita Patel
Bertha Cabrera Lavado, Anita Patel
Day 2
Day 2
Anita Patel
- Key Takeaways & Open Questions from Day 1
Colombia: Marketing authorisation and lifecycle management
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
Practical exercise: Case study for Colombia
- Interactive scenario discussion
Chile: Marketing authorisation and lifecycle management
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
Practical exercise: Case study for Chile
- Interactive scenario discussion
Argentina: Marketing authorisation and lifecycle management
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
Practical exercise: Case study for Argentina
- Interactive scenario discussion
Cross-country comparison and strategy session
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:
in Latin America"?
Please contact us to find out more.
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.

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)
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Further Information
Your Contact Person
We are happy to advise you personally and individually.

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




