ADVANCE is an innovative and focused learning programme for future advanced therapies’ developers.
This first scientific webinar of the second ADVANCE Webinar series will focus on the regulatory and clinical aspects of ATMPs development.
The regulatory framework for advanced therapy medicinal products (ATMPs) is designed to ensure safe patient access to these medicines within the European Union (EU). Several European regulations, directives and guidance, as well as national laws and guidelines, are applicable in the ATMP field, targeting diverse types of ATMPs and aspects of the development pathway.
This webinar will provide a concrete practical example of cells and tissue applications to demonstrate the impact of the ATMP regulatory framework in clinical reality, as well as an overview of the ATMP regulatory framework, as an introduction to the next ADVANCE webinar co-organized with EMA.
- Dr Gilbert Verbeken, Queen Astrid Military Hospital
- Dr Isabelle Huys, KU Leuven