Press Release

Friday, 02 May 2014

ESPOIR receives ENCePP Study Seal / Identifier NCT02035540

The European Clinical Study for the Application of Regenerative Heart Valves received the ENCePP seal and has been officially registered in the ENCePP E-Register of Studies as a Post Authorization Safety Study (PASS), Ref. Number 5064.

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) was established in 2006 by the European Medicines Agency (EMA). The network is comprised of research centres, existing networks and data sources. Its goal is to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on benefit using available expertise and research experience across Europe.

Moreover, the ESPOIR study was announced to the German authorities under Ref. Number NIS242 and has been registered within, a service of the U.S. National Institutes of Health aimed to increase transparency for the public under Identifier NCT02035540.