2024-06-12 2024-06-12 , online online, 1,890 € plus tax Esther Gil López https://www.forum-institut.com/seminar/24092510-marketing-authorisation-in-latin-america/referenten/24/24_09/24092510-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, Chile, Peru
  • Dossier requirements for NCEs and generics
  • Maintenance: variations and renewal
  • Bring your own cases!


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).
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.
Your benefit

  • 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

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 for firsthand information
  • Country by country explanation
  • Marketing authorisation & maintenance addressed
  • Officially certificated ISO 9001 and ISO 21001

Webcode 24092510

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

26-27/09/2024

26-27/09/2024

Period

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

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

online

online

Fee
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@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, Chile, Peru
  • Dossier requirements for NCEs and generics
  • Maintenance: variations and renewal
  • Bring your own cases!


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).

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.

Your benefit

  • 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

Detailed programme

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

10:00 Introductions and agenda


10:30

Esther Gil López

The pharmaceutical market and marketing authorisation 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

11:30 Coffee break


11:40

Esther Gil López

Marketing authorisation and maintenance in Mexico
  • National procedures
  • Dossier requirements for NCEs and generics
  • Maintenance: variation and renewal

12:40 Lunch


13:40

Esther Gil López

Continuation: Marketing authorisation and maintenance in Mexico

14:10

All

Practical activity for Mexico
  • Discuss real cases

14:30 Coffee break


15:00

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

16:30 Short break


16:40

Anita Patel

Continuation: Marketing authorisation and maintenance in Brazil

17:10

All

Practical activity for Brazil
  • Discuss real cases

17:30

Anita Patel

Summarised requirements for Brazil and Mexico

18:00 End of day 1


10:00

Esther Gil López

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

11:00

All

Practical activity for Colombia
  • Discuss real cases

11:20 Coffee break


11:30

Esther Gil López

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

12:20

All

Practical activity for Chile
  • Discuss real cases

12:30 Lunch


13:30

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

14:30 Coffee break


14:40

All

Practical activity for Argentina
  • Discuss real cases

15:00

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

16:00

All

Practical activity for Peru
  • Discuss real cases

16:20 Short break


16:30

Anita Patel

Summarised requirements for all LatAm markets

17:30

All

Wrap-up

18:00 End of seminar


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

Access information and dial-in

Log in to the customer portal at https://members.forum-institut.de/login with your username (email address) and password. Please ensure that you can access the customer portal prior to the event. On the day of the event, you will kick off your online training in the customer portal by clicking 'Participate' in the respective event.

Required technology

  • Make sure you are using a current version of your browser. We recommend Microsoft Edge.
  • You need a reliable Internet connection. Please avoid using a VPN connection.
  • Also, please ensure that your microphone or headset and camera are in good working order.

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.

Further recommendations

Please take a look at the "PharmaFORUM Webcast International" (Webcode: 24112091) program for market approval in various countries around the world. If you are interested in CMC requirements in Latin America, check out the program on our website (Webcode: 24122450).

This distinguishes our events

Overall impression: 100 % of the participants' feedback was very good or good (September 2022)

Course content: 100 % of the participants' feedback was very good or good (September 2022)

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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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