2024-06-12 2024-06-12 , online online, 1,190 € plus tax Estefanny K. Da Silva N. https://www.forum-institut.com/seminar/24122450-cmc-requirements-in-latin-america/referenten/24/24_12/24122450-online-training-course-pharma-cmc-requirements-in-latin-america_da-silva-n-estefanny-k.jpg CMC requirements in Latin America

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
  • 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 onveniently into your daily work routine!
  • Make profit from the practical activity after each talk ("easy learning through application")!

Online training course pharma - CMC requirements in Latin America

CMC requirements
in 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 24122450

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

10-11/12/2024

10-11/12/2024

Period

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
Venue

online

online

Downloads
Fee
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
  • 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 onveniently into your daily work routine!
  • Make profit from the practical activity after each talk ("easy learning through application")!

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


Estefanny Da Silva

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

Estefanny Da Silva

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


Ana Terra Dos Santos Macedo

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.

Estefanny Da Silva

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

Outstanding questions and conclusion


End of online seminar


More information

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