IMPLEMENT - SoHO
BRIEF
The Challenge
The EU adopted Regulation (EU) 2024/1938 on 13 June 2024, introducing a new legal framework for Substances of Human Origin (SoHO) that substantially changes the healthcare pathway from donor registration to human application and clinical outcome registration. The Regulation replaces two separate EU directives on blood and tissues and cells, extends obligations to a broader range of actors and substances (including human milk and faecal microbiota), and sets high standards of quality and safety for SoHO intended for human application.
The core challenge is that different SoHO entities and establishments across Europe are starting from very different positions but must reach the same destination. Many SoHO professionals face variable awareness and preparedness, fragmented cooperation with Competent Authorities, operational and infrastructure gaps, and insufficient data systems. Key technical standards from ECDC, EDQM and the SoHO Coordination Board (SCB) are still being developed, creating uncertainty for timely and harmonised compliance. The transition from directives to a directly applicable Regulation requires not only technical compliance but cultural and organisational adaptation across diverse professional communities.
The project aims to:
- Raise awareness among SoHO stakeholders about the Regulation and its requirements
- Train stakeholders to ensure consistent and effective implementation across Member States
- Provide technical assistance and knowledge exchange to facilitate compliance
- Support the collection and accessibility of scientific evidence on safety, quality, and efficacy of SoHO preparations
- Encourage the use of tools such as registries, databases, and accreditation schemes
- Promote self-sufficiency in SoHO supply through voluntary and unpaid donations
- Support policymaking and active expert engagement with Competent Authorities, Expert Bodies, and Advisory Committees
FOCUS
The Approach
The project applies a needs-driven and stakeholder-centred approach, structured around five tasks:
Task 1 - Mapping: A multi-layered methodological assessment combining desk research, surveys, and exploratory and semi-structured interviews to map the current status and needs of SoHO Scientific Societies, followed by a gap analysis and development of sector-specific action plans.
Task 2 - Training and capacity building: Organisation of face-to-face full-day trainings, online full-day trainings, and exchange visits for professionals across all SoHO sectors, based on the needs identified in Task 1.
Task 3 - Dissemination: Organisation of pre-congress conferences to raise awareness of the new Regulation across the SoHO community.
Task 4 - Scientific opinions and guidance: Development of scientific opinion papers and practical guidance documents through structured drafting groups, peer review, and stakeholder consultation with DG SANTE and Competent Authorities.
Task 5 - Online campaign: Design and implementation of a pan-European English-language online campaign promoting altruistic SoHO donation, with continuous monitoring, refinement, and close cooperation with the SCB, Competent Authorities, and Scientific Societies.
CONCLUSIONS
The Envisioned Result
Once the project is completed, several concrete outputs will have been produced across all five areas of work, including:
1. The project will first deliver a comprehensive assessment of the current state of SoHO Scientific Societies across Europe, mapping their preparedness, identifying gaps, and defining sector-specific action plans that will guide all subsequent activities.
2. Building on this foundation, a substantial capacity-building programme will have been implemented, combining face-to-face training events, online sessions, and structured exchange visits, together reaching over 1,500 professionals across all SoHO sectors and Member States.
3. A series of large-scale pre-congress conferences will have raised awareness of the Regulation's requirements among the broader SoHO community, while a set of peer-reviewed scientific opinion papers and practical guidance documents will provide both regulators and professionals with the evidence and actionable instructions needed to support harmonised implementation.
4. Finally, a pan-European online campaign, including videos, infographics, and social media content, will promote altruistic SoHO donation and support EU self-sufficiency, leaving a lasting public-facing legacy beyond the project's duration.
PREDICTBY
Our Role
Our role in the project consists of conducting the following tasks:
Task 1 - PMO and methodology lead: Coordinating the process, designing and applying the assessment methodology, leading data collection and analysis across all SoHO sectors
All tasks - Project Management Office: Acting as the central coordination hub, serving as the main interface with client, overseeing risk management, quality control, reporting, and internal communication across all consortium partners throughout the 30-month project