In 2019, the European Commison initiated a process of evaluation of the impact of the European directives on blood tissues and cells that highlighted the need for a regulation proposal on the quality and safety of Substances of Human Origin (SoHo). 

On July 17th, 2024, the new European regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC was officially published in the EU Official Journal. 

Given the above an in consideration of the new European legislative framework, Member States (MS) started undertaking the necessary actions during the transitional period that will end in August 2027. In each MS, this path is multi-level (national / regional / local) and multi-actors. 

The event is to be intended:

• As a step of the dissemination of the application process of the new EU regulation until it becomes legally binding in 2007;
• An opportunity to discuss the benefits and challenges for SoHo CAs and national oversight systems coming from the new legislative framework. 

Therefore, the Conference aims at both presenting the experience of some CAs and an overview of the tools and key EU initiatives towards a European common approach of the oversight activities. 

Information related to registration (no fees foreseen) as well as the agenda of the event will be shared in due course. 

For further information, please contact: [email protected]