SHARE SoHO: Safety in Substances of Human Origin

SHARE-SoHO – Supporting Health Authorities on the new REgulation is a European tender established to support National Competent Authorities and Health Authorities of the Member States in the implementation of the new European Regulation on Substances of Human Origin (SoHO) 2024/1938, adopted by the European Commission in May 2024.

The project aims to ensure a harmonised and effective application of the Regulation, which will enter into force on 7 August 2027, enhancing the safety, quality and traceability of blood, tissues, cells and other substances of human origin across the European Union.

The Regulation provides stronger protection for recipients and donors, as well as for children born through medically assisted reproduction.

SHARE-SoHO supports Competent Authorities along the pathway from regulatory assessment to full compliance through six key activities:

mapping of competent authorities and the regulatory framework in each country;
gap analysis to identify regulatory, organisational and operational shortcomings;
implementation of national action plans, supported by specific training plans and practical guidelines designed to address the identified gaps;
delivery of national training pathways, including three-day training courses and the exchange of best practices among Member States;
development of a European training plan (EU training plan) to harmonise procedures and promote cooperation among countries;
dissemination of results, best practices and recommendations for future action.

To achieve these objectives, a consortium of eight partners has been formed: KPMG Advisory S.p.A. (KPMG Italy), as lead partner, together with Centro Nazionale Trapianti and Centro Nazionale Sangue; Zadig; KPMG Germany; KPMG Netherlands; OpenEvidence; Versus Language Solutions; and a network of experts in substances of human origin.

STATO PROGETTO

Ongoing

COMMITTENTE

European Commission

RESPONSABILI

Maria Rosa Valetto

SITO WEB

sightsoho.eu

Zadig’s activities

Zadig’s activities

Zadig is responsible for the design and development of training materials and communication tools and plays a strategic role in Tasks 3 and 5 of the SHARE-SoHO project.

Task 3 – Action plans, training curricula and guidance documents

Zadig will lead the development of tailored action plans for Member States, training programmes and guidance documents, drawing on its experience in designing and delivering customised training pathways.

Task 5 – EU training and guidance framework

Zadig will contribute to the development of European-level guidelines and training tools, supporting the harmonisation of content and procedures across different countries.

All online training materials will be delivered through the SIGHTSoHO platform.