Marketing Authorisation in Latin America

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 to so that the speakers can prepare themselves prior to the meeting.

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 to so that the speakers can prepare themselves prior to the meeting.

Detailed programme

Detailed programme

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

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

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