WORK PACKAGE ARCHITECTURE

Context:

Gene and cellular therapies are subject to EU and national regulations affecting their preparation, administration and patient access. These new therapies challenge the  regulations which were designed for more traditional pharmaceutical products and health authorities are assessing how they will adapt.

Overall aim:

Represent and promote the interests of the GoCART coalition and its stakeholders in EU policy making by engaging with EU institutions and other relevant stakeholders. 

Activities to be developed:

• Develop a shared policy and advocacy strategy
• Advocate key coalition positions with policy makers
• Contribute to European policy making on topics concerning gene and cellular therapies from cells and tissues of hematopoietic origin 
• Specific topics of interest include but are not limited to: regulation on Substances of Human Origin and Hospital Exemption.