- Adaptation from EU and differences within Latam (Latin America) - CMC requirements in Brazil, Mexico, Colombia, Argentina,
Chile, Peru:
Documentation, country specific requirements, post-approval activities, future trends in the regionsCMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.LernzieleDuring 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 different regions.ZielgruppenThis 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.
- Adaptation from EU and differences within Latam (Latin America) - CMC requirements in Brazil, Mexico, Colombia, Argentina,
Chile, Peru:
Documentation, country specific requirements, post-approval ... Mehr Informationen