2021-12-19 2022-09-20 , Online Online, 1.790,- € zzgl. MwSt. Esther Gil López https://www.forum-institut.de/seminar/22092610-marketing-authorisation-in-latin-america/referenten/22/22_09/22092610-course-marketing-authorisation-in-latin-america_gil-lpez-esther.jpg Marketing Authorisation in Latin America

An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.

Topics
  • LATAM - regulatory environment and harmonisation trends
  • National procedures in Brazil, Mexico, Argentina, Colombia, Peru
  • Dossier requirements for NCEs and generics
  • Maintenance: variations and renewal
Aims and objectives
What are the key success factors in introducing your products in the LATAM region? What do you have to keep in mind when applying for a marketing authorisation in these countries?

This online seminar will enable you to answer these questions and will provide deep insights into the regulatory environments of the various markets.

Two LATAM experts will share valuable information regarding:
  • dossier requirements,
  • marketing authorisation procedures and
  • maintenance duties.

In interactive sessions, you will learn about key challenges for each market and will also be given the chance to discuss your own cases. Thus, you will gain better understanding of the regulatory affairs business in the LATAM region.
Who should attend

This online seminar will be of benefit to all those working in the pharmaceutical industry, particularly in regulatory affairs and business development, who are interested in marketing pharmaceuticals in Latin America.

The seminar will focus on human medicinal products (chemicals and biologics; herbals will not be addressed).

Course Marketing Authorisation in Latin America

Marketing Authorisation in Latin America

Online seminar with a focus on: Brazil, Mexico, Argentina, Colombia, Peru

Benefits
  • Local experts
  • Detailed documentation
  • Combinable with the CMC course (Webcode 2109276)
  • An e-Learning can be booked
  • We are following the IMI quality criteria

Webcode 22092610

Jetzt buchen

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Referenten


Alles auf einen Blick

Termin

19. - 20.09.2022

19. - 20.09.2022

Zeitraum

from 10:00 - 18:00 on both daysYou m...

from 10:00 - 18:00 on both days
You may dial in 30 min. before the session
Veranstaltungsort

Online

Online

Downloads
Gebühr
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.

Topics
  • LATAM - regulatory environment and harmonisation trends
  • National procedures in Brazil, Mexico, Argentina, Colombia, Peru
  • Dossier requirements for NCEs and generics
  • Maintenance: variations and renewal
Aims and objectives

What are the key success factors in introducing your products in the LATAM region? What do you have to keep in mind when applying for a marketing authorisation in these countries?

This online seminar will enable you to answer these questions and will provide deep insights into the regulatory environments of the various markets.

Two LATAM experts will share valuable information regarding:

  • dossier requirements,
  • marketing authorisation procedures and
  • maintenance duties.

In interactive sessions, you will learn about key challenges for each market and will also be given the chance to discuss your own cases. Thus, you will gain better understanding of the regulatory affairs business in the LATAM region.

Who should attend

This online seminar will be of benefit to all those working in the pharmaceutical industry, particularly in regulatory affairs and business development, who are interested in marketing pharmaceuticals in Latin America.

The seminar will focus on human medicinal products (chemicals and biologics; herbals will not be addressed).

Detailed programme

from 10:00 - 18:00 on both days
You may dial in 30 min. before the session

Esther Gil López

The pharmaceutical market and marketing authorisation (MA) in Latin America
  • LATAM - key figures and regulatory environment
  • The local pharmaceutical market - success strategies
  • Registration for emerging markets
  • Harmonisation trends in the LATAM region

Anita Patel

Marketing authorisation and maintenance in Brazil
  • National procedures
  • Dossier requirements for NCEs and generics
  • Maintenance: variation and renewal
  • Practical activity: discuss real cases/challenges for marketing authorisation in Brazil*

Esther Gil López

Marketing authorisation and maintenance in Mexico
  • National procedures
  • Dossier requirements for NCEs and generics
  • Maintenance: variation and renewal
  • Practical activity: discuss real cases/challenges for marketing authorisation in Mexico*

Esther Gil López

Marketing authorisation and maintenance in Colombia
  • National procedure
  • Dossier requirements for NCEs and generics
  • Maintenance: variation and renewal
  • Practical activity: discuss real cases/challenges for marketing authorisation in Colombia*

Anita Patel

Marketing authorisation and maintenance in Argentina
  • National procedures
  • Dossier requirements for NCEs and generics
  • Maintenance: variation and renewal
  • Practical activity: discuss real cases/challenges for marketing authorisation in Argentina*

Anita Patel

Marketing authorisation and maintenance in Peru
  • National procedures
  • Dossier requirements for NCEs and generics
  • Maintenance: variation and renewal
  • Practical activity: discuss real cases/challenges for marketing authorisation in Peru*
*Own cases can also be discussed.Please email the case details toh.wolf-klein@forum-institut.de sothat the speakers can preparethemselves prior to the meeting.

More information

Your benefit of this seminar

  • You will meet experts with local know-how and firsthand experience
  • You will get deep insights into the Brasilian, Mexican, Colombian and Argentinian markets
  • You will discuss real cases/own cases regarding each country

e-Learning: Marketing Authorisation Outside the ICH Region

Do you need regulatory affairs expertise for submissions outside the ICH region? Then this e-learning programme is the fast track to becoming knowledgeable in this field, providing you with the fundamentals of regulatory affairs outside the EU, the US and Japan.

The e-learning programme will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements.

Subsequently, you will be able to assess the data necessary to apply for a marketing authorisation and be knowledgeable about the CPP requirements. In other words, you will have the tools to develop a submission strategy.

E-learning principles

The e-learning programme 'Marketing Authorisation Outside the ICH Region' comprises three didactic modules that include videos in which the expert Karl-Heinz Loebel shares his expertise with you. You can also download and print the corresponding presentation documents.

Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.

Once you have completed the three modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.

How to book the e-learning programme in addition to the seminar

Please register for the seminar "Marketing Authorisation in Latin America" by clicking '"Register"'or "Buchen. You will receive a €100 discount if you also book the e-learning programme (you will be billed €290 + local VAT rather than €390 + local VAT).

The benefits of an online seminar

  • Attend the webcasts in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live, using the chat function

This distinguishes our events

Overall impression: 100 % of the participants' feedback was very good or good (September 2020)

Course content: 100 % of the participants' feedback was very good or good (September 2020)

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Quality guaranteed!

Your feedback produced as result of 1.8 in 2021. Thank you!

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Testimonials

This seminar deals with regulatory aspects in Latin American countries. The seminar is conducted by very experienced speakers from Spain and Brazil. There are practical activities that enable you to deepen the knowledge you have acquired. The seminar left a very positive impression in terms of the knowledge imparted and the technical competence of the speakers.

Both speakers were great!

I wanted to get a comprehensive overview of the regulatory issues in Latin American countries. The seminar exceeded my expectations


Brazil requirements very helpful

Andrea and Esther did a very good Job; I expected an overview about the regulations and specific issues, and I get one.

Specific questions relating to Brazil - expectation met