2025-04-24 2025-04-24 , online online, 1,290 € zzgl. MwSt. Vitoria Bochner https://www.forum-institut.de/seminar/25122451-global-cmc-requirements-focus-on-latin-america-latam-countries/referenten/25/25_12/25122451-training-pharma-global-cmc-requirements-latin-americalatam_bochner-vitoria.jpg Global CMC requirements: focus on Latin America/Latam countries

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

Topics
  • Adaptation from EU and differences within Latam (Latin America)
  • CMC requirements in Brazil, Mexico, Colombia, Argentina, Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions


Who should attend
This seminar will be of benefit to all those working in the pharmaceutical industry, particularly CMC and regulatory affairs managers, who are dealing with dossier compilation (quality data/module 3) for regions in Latin America.

The seminar will focus on small molecules.
Aims and objectives
During this seminar you will learn about the specific CMC requirements for the different countries in Latin America with a focus on Brazil, Mexico, Colombia, Argentina, Chile and Peru.

Three (local) experts will share valuable information regarding
  • pharmaceutical documentation;
  • country specific requirements;
  • post-approval activities and
  • future trends.

After the training course you will have gained a better understanding of the additional and differing CMC related requirements and procedures in the different regions.
Your benefit

  • Meet three (local) experts that will share in-depth knowledge with you!
  • Obtain practical CMC know-how for emerging markets!
  • Integrate the two half days conveniently into your daily work routine!
  • Make profit from the practical activity after each talk ("easy learning through application")!


Here are some "voices" of participants from last year's course:
  • "A successful and informative event that I really enjoyed"
  • "Very detailed documentation"
  • "Practical approach, very useful, possibility to ask specific questions"
  • "Very good and commprehensive overview."
  • "Very interesting seminar, very helpful, thank you"

Online training course pharma - CMC requirements in Latin America

Global CMC requirements:
with a focus on Latin America

- Online training -

Benefits
  • Experts with local know-how
  • Practical activity after each talk
  • Inform us about your most relevant countries/regions
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25122451

Jetzt buchen

JETZT Buchen
Referenten

Vitoria Bochner

Parexel International, Rio de Janeiro, BRAZIL

CMC Regulatory Affairs - Senior Associate Vitoria holds a bachelor's degree in pharmacy, from Federal University of Rio de Janeiro, and is currently undergoing a master's program specialized in CMC RA. She has 5 and half years of solid experience in Brazil Regulatory Affairs and is specialized on global brands of small molecules/synthetic drugs, along with extensive expertise in marketing authorization transfers of all categories. Vitoria is experienced in CMC dossier creation of post approval variations to be submitted in LATAM markets (exportation products). Currently Vitoria is allocated in a large molecules CMC project to ensure timely submission of a biological anti-cancer drug in Rest of World countries.
More information please click here.

Julieta Breton

PAREXEL International, Buenos Aires, ARGENTINA

Associate at Regulatory Affairs Julieta Breton has 10 years of experience in the pharmaceutical industry, involving in activities related to quality control, R&D, pharmacovigilance and regulatory affairs. She has strong experience in preparation of marketing authorization applications for medicinal products, and activities related with the pharmaceutical industry as new sites of authorization and product variations. Currently Julieta is responsible of MA submissions and maintenance of wide portfolio of products in the International division (LATAM and Central American Region).

Carolin Elzer

Boehringer Ingelheim International GmbH, Ingelheim, GERMANY

Global Regulatory Affairs

Alles auf einen Blick

Termin

01-02/12/2025

01-02/12/2025

Zeitraum

Day I: 01:00 pm - 5:15 pm - seminar
Day II: 01:00 pm - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Day I: 01:00 pm - 5:15 pm - seminar
Day II: 01:00 pm - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
Gebühr

Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

Topics

  • Adaptation from EU and differences within Latam (Latin America)
  • CMC requirements in Brazil, Mexico, Colombia, Argentina, Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions


Who should attend
This seminar will be of benefit to all those working in the pharmaceutical industry, particularly CMC and regulatory affairs managers, who are dealing with dossier compilation (quality data/module 3) for regions in Latin America.

The seminar will focus on small molecules.

Aims and objectives

During this seminar you will learn about the specific CMC requirements for the different countries in Latin America with a focus on Brazil, Mexico, Colombia, Argentina, Chile and Peru.

Three (local) experts will share valuable information regarding

  • pharmaceutical documentation;
  • country specific requirements;
  • post-approval activities and
  • future trends.

After the training course you will have gained a better understanding of the additional and differing CMC related requirements and procedures in the different regions.

Your benefit

  • Meet three (local) experts that will share in-depth knowledge with you!
  • Obtain practical CMC know-how for emerging markets!
  • Integrate the two half days conveniently into your daily work routine!
  • Make profit from the practical activity after each talk ("easy learning through application")!


Here are some "voices" of participants from last year's course:
  • "A successful and informative event that I really enjoyed"
  • "Very detailed documentation"
  • "Practical approach, very useful, possibility to ask specific questions"
  • "Very good and commprehensive overview."
  • "Very interesting seminar, very helpful, thank you"

Detailed programme

Day I: 01:00 pm - 5:15 pm - seminar
Day II: 01:00 pm - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Welcome, introduction round, expectations


Carolin Elzer

Latam Overview
  • Overview of the Latam Region
  • Adaptation from EU and differences within LatAm

Carolin Elzer

CMC requirements in Mexico
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation in Mexico
  • Future trends
  • Practical activity

Coffee break


Vitoria Gomes Bochner

CMC requirements in Brazil
Same content as lecture on Mexico.

Q&As


End of day I


Recap and outstanding questions of day I


Julieta Breton

CMC requirements in Argentina and Chile
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation in Mexico
  • Future trends
  • Practical activity

Coffee break


Julieta Breton

CMC requirements in Peru
Same content as lecture on Argentina and Chile.

Carolin Elzer

CMC requirements in Colombia
Same content as lecture on Argentina and Chile.

Outstanding questions and conclusion


End of online seminar


More information

Modular qualification course CMC Specialist

This seminar can be taken as elective module as part of our qualification program to become a CMC Specialist.

The course concept:

  • You attend our basic course "CMC Management in Regulatory Affairs"
  • Then you choose and take part in 3 further seminar modules (= 3 seminar days), which you put together individually from the course plan.
  • You receive structured further training and comprehensive knowledge in CMC-relevant topics.
  • You can specialise according to your main area of business activity by selecting the seminars specifically.

For more information, please visit our Website

In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

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.

This distinguishes our events

of 5 stars of all ratings from 2024

of 5 stars on Trustpilot = good

Recommendations

CMC Management in Regulatory Affairs

This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chan...

22. - 23.05.2025 in
Details

Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, you will gain a c...

19. - 21.05.2025 in
Details

Biopharmaceuticals

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place...

03. - 05.06.2025 in
Details

An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a ...

28. - 29.04.2025 in
Details

Regulatory Lifecycle Management

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submi...

04.06.2025 in
Details

Go forward

Whitepaper: MA and lifecycle management in Japan

This whitepaper describes what you need to keep in mind when it comes to specific Japanese CMC requirements for marketin...

Details
Whitepaper: MA and lifecycle management in Japan
DEMO-Account

Try out our e-Learning programmes free of charge and without any obligation.

Details
DEMO Account
Our rating in 2024

More than 4,000 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.

Details
Our rating in 2024