European SIGHTSoHO Project: Over 100 Professionals Trained in the Second Round of Online Training

The second round of online training of the European SIGHTSoHO project (Strengthening overSIGHT through training and networking on Substances of Human Origin) came to an end on 30 April with a closing online event. The programme is dedicated to the training of inspectors, assessors and vigilance officers working in the fields of blood, cells, tissues and organs.

Funded by the European Commission through the European Health and Digital Executive Agency (HaDEA), the programme is coordinated by the Istituto Superiore di Sanità (ISS) through the National Blood Centre (CNS) and the National Transplant Centre (CNT). For the second consecutive year, Zadig supported the coordination as a joint tender partner, being responsible for the design and management of the e-learning platform.

The closing event provided an opportunity to review the eleven weeks of training of the second cycle, which took place between January and April 2025 and involved 102 participants — including inspectors, assessors and vigilance officers — from 20 European Union countries.

SoHO biovigilance, risk management, EU regulations and directives on medical devices, and the facilitation of the authorisation of the preparation process (GAPP) for blood, tissues and cells were among the many topics covered in a rich and structured programme, which this year included two live sessions per week. The new Regulation of the European Parliament and of the Council, adopted on 13 June 2024, on quality and safety standards for substances of human origin intended for human application — which will enter into force in 2027 — was also discussed.

Overall feedback from participants, collected through an emoji-based survey, was very positive, as was the assessment of knowledge acquisition. The weekly live sessions were particularly appreciated and recognised as valuable opportunities for exchange among colleagues from different European countries, tutors and external experts. The gamified learning activities introduced in this second edition were also well received.

The project now continues with the residential training phase in Rome, which will run until July 2025, allowing participants to further deepen their knowledge and engage directly with tutors and European peers.