2021-12-21 2022-09-22 , online online, 1.090,- € zzgl. MwSt. Estefanny K. Da Silva N. https://www.forum-institut.de/seminar/22092450-cmc-requirements-in-latin-america/referenten/22/22_09/22092450-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 Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and participate online! This course may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (webcode 22092610) (special rate available).

Topics
  • Quality data for marketing authorisation: The formats
  • CMC requirements in Brazil, Mexico, Colombia, Argentina, Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions
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 LATAM region.
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 seminar will focus on small molecules.

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
  • This expertise will benefit your company
  • Combinable with the MA course (22092610)
  • We follow the IMI quality criteria

Webcode 22092450

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

21. - 22.09.2022

21. - 22.09.2022

Zeitraum

Day I: 01:00 pm - 5:00 pm - seminarD...

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

online

online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

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

Details

CMC requirements in Latin America with focus Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and participate online! This course may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (webcode 22092610) (special rate available).

Topics
  • Quality data for marketing authorisation: The formats
  • CMC requirements in Brazil, Mexico, Colombia, Argentina, Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions
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 LATAM region.

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 seminar will focus on small molecules.

Detailed programme

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

13:00 Welcome and introduction round


13:15

Ana Terra Dos Santos Macedo

Quality data for marketing authorization: The formats
  • CTD module 2.3 and module 3: Important facts

14:00

CMC requirements in Brazil
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements (specific formats)
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation
  • Future trends

14:10

Estefanny Da Silva

CMC requirements in Mexico
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation
  • Future trends

15:25

Ana Terra Dos Santos Macedo

CMC requirements in Colombia
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures
  • Future trends

15:35

Vitor Kimura

CMC requirements in Argentina and Chile
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation
  • Future trends

16:50

Vitor Kimura

CMC requirements in Peru
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation
  • Future trends

17:00 Q&As and outstanding questions


13:00

Ana Terra Dos Santos Macedo

CMC requirements in Colombia
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation in Colombia
  • Future trends

14:10 Coffee break


14:20

Vitor Kimura

CMC requirements in Argentina and Chile
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation in Argentina
  • Future trends

15:50 Coffee break


16:00

Vitor Kimura

CMC requirements in Peru
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Lifecycle management: Post-approval changes: Standards in the ICH region, Additional and differing procedures/documentation in Peru
  • Future trends

16:50 Summary and outstanding questions


17:00 End of the online training course


Additional offer

Combineable online training

Combineable with our online training Marketing Authorisation in Latin America. Simply register for the seminar "Marketing Authorisation in Latin America" and you will receive a €390 discount on the seminar (€1.400 + local VAT rather than €1.790 € + local VAT) if you book it simultaneously.

More information

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

Booking options

The course "CMC requirements in Latin America" may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (22092610). A special rate is available.

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 2021

Five stars on Trustpilot = Excellent

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