A course to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.
Sostanze stupefacenti e psicotrope
Decreto attuativo della Legge Lorenzin
This course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
Uso Compassionevole, Off Label e Off-Licence dei medicinali
Serializzazione e anti-contraffazione dei medicinali
This course provides guidance on uncommon parts of the procedures, explaining the major steps to be taken and the best practices to avoid further complications. In addition, the major differences and
difficulties in states outside Europe are covered to provide a more global view.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.