2023-01-30 2023-01-30 , online online, 1,490 € plus tax Ana Terra Dos Santos Macedo https://www.forum-institut.com/seminar/23042453-cmc-requirements-in-latin-america/referenten/23/23_04/23042453-online-training-course-pharma-cmc-requirements-in-latin-america_dos-santos-macedo-ana-terra.jpg CMC requirements in Latin America

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, Peru and CAMCAR (Central America and Caribbean). The webcast format is comfortable to integrate into your daily work routine. You desire to choose only single webcast sessions? Contact us!

Topics
  • Quality data for marketing authorisation: The formats
  • CMC requirements in Mexico, Brazil, Colombia, Argentina, Chile, Peru and CAMCAR (Central America and Caribbean): Documentation, country specific requirements, post-approval activities, future trends in the regions


Who should attend
This online 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 webcast series will focus on small molecules.
Aims and objectives
During this webcast series you will learn about the specific CMC requirements in Latin America (Mexico, Brazil, Colombia, Argentina, Chile, Peru, CAMCAR).

Three (local) experts will share valuable information regarding
  • pharmaceutical documentation,
  • country specific requirements and
  • avoidance of typical mistakes.

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 webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Online training course pharma - CMC requirements in Latin America

CMC requirements
in Latin America

- Online training -

Benefits
  • First-hand information
  • Pose your questions prior to the training
  • Webcast format: Convenient to integrate into your daily work routine
  • We follow the IMI quality criteria

Webcode 23042453

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

anytime

anytime

Period

19 April, 26 April, 3 May, 10 May, 1...

19 April, 26 April, 3 May, 10 May, 17 May, 24 May 2023 each from 2:00 pm - 4:00 pm CET (= UTC+2) - live webcast
You may dial in 30 minutes before the training starts
Venue

online

online

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, Peru and CAMCAR (Central America and Caribbean). The webcast format is comfortable to integrate into your daily work routine. You desire to choose only single webcast sessions? Contact us!

Topics
  • Quality data for marketing authorisation: The formats
  • CMC requirements in Mexico, Brazil, Colombia, Argentina, Chile, Peru and CAMCAR (Central America and Caribbean): Documentation, country specific requirements, post-approval activities, future trends in the regions


Who should attend
This online 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 webcast series will focus on small molecules.
Aims and objectives

During this webcast series you will learn about the specific CMC requirements in Latin America (Mexico, Brazil, Colombia, Argentina, Chile, Peru, CAMCAR).

Three (local) experts will share valuable information regarding

  • pharmaceutical documentation,
  • country specific requirements and
  • avoidance of typical mistakes.

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 webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Detailed programme

19 April, 26 April, 3 May, 10 May, 17 May, 24 May 2023 each from 2:00 pm - 4:00 pm CET (= UTC+2) - live webcast
You may dial in 30 minutes before the training starts

14:00 Welcome, expectations, introduction


14:15

Estefanny Da Silva

19 April 2023: Overview of LATAM region and CMC requirements in Mexico
  • Overview of LATAM region
  • Adaptation from EU and differences within LATAM

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

15:45 Q&As


16:00 End of webcast


14:00 Welcome and introduction round


14:10

Estefanny Da Silva and Julieta Breton

26 April 2023: CMC requirements in CAMCAR (Central America and Caribbean)
  • 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 CAMCAR
  • Future trends

15:45 Q&As


16:00 End of webcast


14:00 Welcome and introduction round


14:10

Julieta Breton

3 May 2023: 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 Argentina and Chile
  • Future trends

15:45 Q&As


16:00 End of webcast


14:00 Welcome and introduction round


14:10

Julieta Breton

10 May 2023: CMC requirements in Peru
  • 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 Peru
  • Future trends

15:45 Q&As


16:00 End of webcast


14:00 Welcome and introduction round


14:10

Ana Terra Dos Santos Macedo

17 May 2023: CMC requirements in Brazil
  • 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 Brazil
  • Future trends

15:45 Q&As


16:00 End of webcast


14:00 Welcome and introduction round


14:10

Estefanny Da Silva

24 May 2023: CMC requirements in Colombia
  • 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 Colombia
  • Future trends

15:45 Q&As


16:00 End of webcast


More information

Webcast series: CMC requirements in MENA regions (23012450)

You are working with affiliates or external partners in MENA?

Four (local) experts will share their in-depth knowledge on CMC requirements in these regions (focus Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Türkiye, Iran and Egypt) with you - webcasts scheduled weekly in January 2023.

For more information visit our website using the webcode 23012450.

Webcast series: CMC requirements in Asia, Japan and Eastern Europe (23032451)

You are working with affiliates or external partners in Asia, Japan or Eastern Europe/EAEU?

Four (local) experts will share their in-depth knowledge on CMC requirements in these regions (focus China, India, Japan and Korea, Russia/EAEU) with you - webcasts scheduled weekly in March 2023.

For more information visit our website using the webcode 23032451.

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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.

This distinguishes our events

Overall score of all evaluations in 2022

Five stars on Trustpilot = Excellent

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