strengthening overSIGHT through training and networking on Substances of Human Origin

In the “phase out” from the Covid-19 epidemiological contingency, the achievement/enhancement of an effective and robust national and European oversight of the inspection, authorisation and vigilance sectors is a pivotal objective.

Starting from the nomination of Competent Authorities (CAs) responsible for oversight at Member State level, the establishment of a CA network at European level as well as the definition of common minimum safety and quality requirements, inspection, authorisation and vigilance systems were set-up at both levels with the purposes of implementing safety and quality and regulatory oversight.
Many projects and joint actions brought positive outcomes with particular regard to inspection and vigilance systems. However, lack of equivalency in relation to regulatory oversight is still present across Europe. Within this framework, the need to have up-to-date trained professionals on common approaches has turned out to be a key aspect especially with regard to inspection, authorisation and vigilance sectors. Indeed, all the above was further highlighted through the evaluation of the BTC legislation in 2019 and the Impact Assessment published in 2021, both including consultations with stakeholders, and resulting in the proposal of a Regulation of the European Parliament and of the Council 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.

In the last years, both CAs and professionals as well as the European Commission (EC) expressed the willingness and interest in training initiatives that were successfully delivered also within EU projects and Joint Actions. In occasion of the latter, the CNS and the CNT, in collaboration with key European experts, played a strategic role in coordinating the initiatives and/or leading specific activities with particular regard to the training ones. At the same time, the EC established two expert sub-groups (IES and VES) that, according to their terms of reference, provide technical expertise and formulate advice and comment to the Commission's services on matters related to inspection and vigilance systems in the blood and tissues and cells sectors. In both groups, specific attention is devoted to training opportunities addressed to professionals and inspectors on common guidance and tools.
Therefore, the organisation of a dedicated European training initiative for inspectors, assessors and vigilance officers stands as an opportunity for all CAs.
In both inspection and vigilance sectors, it is clear that having European vigilance officers, assessors and inspectors periodically trained on the same minimum common approach, which itself calls for a constant update, is a priority for the MS and the EU to guarantee oversight at European and national level.

In this context, SIGHTSoHO Service will provide blended training activities (eLearning and Face-to-Face) to further encourage and promote:

  • the “formal” recognition of the commonalities among BTC oversight processes and the adoption of a common approach for the evaluation and inspection of SoHO;
  • the harmonisation and standardisation of some key minimum competencies/knowledge of SoHO inspectors, assessors and vigilance officers;
  • the strengthening of the existing network to foster trust between EU inspectorates and CAs to allow mutual recognition of certifications and authorisations of BTC establishments.