Date: 27 August to 13 October 2025

 Location: Online

 Working language: English

Ensuring that substances of human origin (SoHO) intended for human application consistently meet high quality standards, as well as technical and legal requirements, is essential. In recent decades, significant developments have reshaped the organisation of SoHO entities and the methods they use to ensure safety and quality. The concept of quality management (QM) has evolved significantly within this field, requiring continual adaptation to emerging standards and requirements. 

The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe plays a key role in the field of SoHO by facilitating the exchange of knowledge and promoting the harmonisation of practices across Europe. It captures changes in the field in regular updates to two of its major SoHO guides, the Guide to the preparation, use and quality assurance of blood components (Blood Guide) and the Guide to the quality and safety of tissues and cells for human application (TC Guide), which aim to provide essential guidance to optimise quality and minimise the risks of the complex procedures undertaken in this field. 

The objective of the virtual SoHO-Quality Management (SoHO-QM) training course was to equip entities in Council of Europe member states that handle SoHO with the tools and knowledge needed to successfully implement a comprehensive, robust, risk-based quality management system (QMS). It was intended for professionals working in SoHO entities who play an active role in quality management to support them to implement and enhance their QMS in line with the latest regulatory and technical standards. 

In contrast to previous EDQM training courses that focused on either blood or tissues and cells, this course covered a wide range of subjects, including blood, tissues, cells, intestinal microbiota and human breast milk, taking into account the Good Practice Guidelines (GPG) published in the Blood and TC Guides. It also included updates from Regulation (EU) 2024/1938 of the European Parliament and the Council on standards of quality and safety standards for SoHO intended for human application (the “SoHO Regulation”). 

The first edition of this training course marked the launch of a new series of SoHO-QM courses co-ordinated by the EDQM and delivered in English. The second and third editions of the virtual course will take place in 2026 and 2027, respectively, along with in-person workshops on specific QM topics. If you are interested in participating in future training courses, subscribe to the EDQM newsletter or follow us on social media for updates.
 

The course covered the fundamental aspects of QM in the field of SoHO and provided guidance on how to ensure their implementation.

The main topics were:

• Quality Management within the legislative framework
• EDQM guides and GPG
• Personnel management
• Cold-chain management
• Environmental monitoring
• Quality indicators
• Corrective and preventive action (CAPA)
• Microbiological testing
• Internal audits
• Quality risk management and assessment 
• Risk assessment tools (EuroGTP II, MiRCA)
• Change control management
• Qualification, validation and verification 
• Haemovigilance and biovigilance
• Traceability, coding systems and witnessing
• Contingency planning

The first edition of this course took place from 27 August to 13 October 2025.

It was developed by leading European experts in the field to help participants build both theoretical knowledge and practical competencies through a blended learning approach:

• Self-training phase: this self-paced learning period was divided into three modules, each lasting approximately one week. At the beginning of each module, participants were given access to:
  • pre-recorded video lectures;
  • carefully selected reading materials to deepen their understanding of the topics.
• Q&A sessions: held at the end of each module, these live online sessions offered participants the opportunity to engage directly with experts, clarify concepts and discuss the practical implications of what they had studied.
• Practical case studies: the aim of these live sessions was to provide guidance to participants on how to apply the knowledge gained during the self-training phase in a more practical context, exploring real-world scenarios and address concrete challenges from their professional context.
   

This training course was developed for staff working in SoHO entities in Council of Europe member states responsible for implementing, co-ordinating or improving their QMS (such as quality managers or responsible persons). 

Participation in this course was free of charge. It was co-funded by the EDQM/Council of Europe and the European Commission.

Download for free the EDQM’s:

• Guide to the quality and safety of tissues and cells for human application
• Guide to the preparation, use and quality assurance of blood components