In this video, we will address how to plan for drug development using tools and methods such as reverse planning, Target Product Profile and applicable standards for quality , non – clinical and clinical (i.e. GMP, GLP, GCP). We will also discuss how an orphan designation can provide benefit in the development of medicines for rare disease and highlight the different regulatory support mechanisms are available to academics.
Introduction to the regulatory framework of medicinal products
The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575.
The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.