CMC requirements in Latin America
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
CMC requirements in Latin America - focus Brazil, Mexico, Colombia, Argentina 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" (2109231) (special rate available).
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Themen
- Country
- Marketing
- Management
Inhalte
Detailed programme
9:00 am - 5:30 pm
13:00
Welcome and introduction round
13:15
Quality data for marketing authorization: The formats
- CTD module 2.3 and module 3: Important facts
- Specific formats in e.g. Brazil
14:00 Coffee break
14:15
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
15:45
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
13:00
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
14:15
CMC requirements in Argentina
- 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
15:30 Coffee break
15:45
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
17:00 Future trends in the regions
17:20 Concluding discussion
17:30 End of the online training course
Detailed programme
9:00 am - 5:30 pm
13:00
Welcome and introduction round
13:15
Quality data for marketing authorization: The formats
- CTD module 2.3 and module 3: Important facts
- Specific formats in e.g. Brazil
14:00 Coffee break
14:15
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
15:45
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
13:00
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 ...
CMC requirements in Latin America