Competent Authority Training of Inspections in Europe (CATIE)

The European Commission has contracted the CATIE consortium (Competent authority training on Inspections in Europe) for a study on the set-up of a training programme for regulatory inspectors following Article 8 of the Directive 2002/98/EC in Europe.
The consortium is composed by several competent authorities in the field of safety and quality of blood products:

  • Paul-Ehrlich-Institut (PEI), Germany
  • Centro Nazionale Sangue (CNS), Italy
  • The Portuguese Blood and Transplant Institute (IPST), Portugal
  • Ministerio de Sanidad, Politica Social e Igualdad (MSPSI), Spain
  • Agence nationale de sécurité du médicament et des produits de santé (ansm), France
  • Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP), Slovenia
  • in coordination with the German Red Cross, Blood Donor Service (GRCBDS), Germany).

The study will take place from January 2012 until summer 2013.

The CATIE consortium will develop and organise training sessions for a limited number of inspectors of competent authorities on blood. The training aims to improve mutual knowledge and understanding of inspections in the EU and will allow to further disseminate best practice and expertise. This will help strengthen mutual trust and collaboration among Member States.
The CATIE consortium has been awarded this contract following the publication of a call for tender that the Executive Agency for Health and Consumers (EAHC) launched in September 2011 (EAHC/2011/HEALTH/13).

Most contacts with national Competent Authorities and representatives will take place between March and September 2012. CATIE will send the Competent Authorities

(1) a pre-registration form for interested staff members in your authority*
(see also pre-registration for CATIE workshops)

(2) a survey questionnaire to understand the training activities and needs in your

Progress of the project will be reported by the CATIE consortium on a regular basis to the Commission and the project will be presented during the meetings of Competent Authorities at the European Commission, DG Sanco in Brussels.