Events

Overview: 

Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.

The ATMP Regulation 1394/2007 aims to facilitate the patient access to these products and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients.

Why should you Attend: Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury. 

As this is a new area, early contacts with the regulatory authorities are particularly important. There are a number of procedures available during the development of these products. These procedures are explained in this webinar. Companies can apply to the European Medicines Agency to determine whether a medicine they are developing is an advanced-therapy medicinal product (ATMP). The procedure allows them to receive certification that a medicine, based on genes, cells or tissues, meets the scientific criteria that define ATMPs. The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced-therapy medicinal products (ATMPs) under development by micro, small and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development.