The objective of this training course is to equip entities in Council of Europe member states that handle substances of human origin (SoHO) with the tools and knowledge needed to successfully implement a comprehensive, robust, risk-based quality management system (QMS). This system should encompass all activities undertaken by SoHO entities, from the recruitment and evaluation of potential donors through to the processing, testing, storage and final preparation and distribution of SoHO for human application.

Ensuring that 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 and the Guide to the quality and safety of tissues and cells for human application, which aim to provide essential guidance to optimise quality and minimise the risks of the complex procedures undertaken in this field. 

This training course will cover a wide range of subjects, including blood, tissues, cells, intestinal microbiota and human breast milk. It will also address 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”).

It is intended for professionals currently working in SoHO entities who play an active role in QM, and aims to support these entities to implement and enhance their QMS in line with the latest regulatory and technical standards.

The course will cover the fundamental aspects of QM in the field of SoHO and will provide guidance on how to ensure its implementation.

The main topics that will be covered are:

• Quality management within the legislative framework
• EDQM guides and Good Practice Guidelines (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 working language of the training course is English.

The course will take place from 20 April to 18 June 2026.

The course has been developed by leading European experts in the field and is designed to help participants build both theoretical knowledge and practical competencies through a blended learning approach structured around three key components:

• Self-study phase (from 20 April 2026): this self-paced learning period is divided into three modules, each lasting two weeks. At the beginning of each module, participants will receive access to:
  • pre-recorded video lectures to watch at their convenience;
  • carefully selected reading material to deepen their understanding of the topics.
• Practical case studies (from 1 June 2026): these live sessions are grouped by area of expertise – blood, tissues & cells or medically assisted reproduction (MAR) – and are designed to allow participants to apply the knowledge gained during the self-study phase and explore real-world case studies.
• Q&A sessions (from 5 June 2026) dedicated to each field (blood, tissues & cells or MAR): these live sessions offer participants the opportunity to engage directly with experts from their field of expertise, to ask questions concerning the course material and clarify QM concepts.

Please be aware that, due to the large number of participants, most live sessions will have to be separated by area of expertise (blood, tissues & cells or MAR). As part of the course registration, you will be asked to choose one of these fields and will only be able to follow the live sessions of that field. However, you will have access to the entire range of course materials, including the pre-recorded video lectures, reading materials and written Q&A documents for all SoHO types.

Please ensure you will be available on the following dates and times before applying:

Practical case studies (attendance mandatory for obtaining a course certificate):

• Tissues & cells: Tuesday 2 June 2026, from 14:30 to 17:00 (CEST, Paris, France)
• MAR: Thursday 4 June 2026, from 10:00 to 12:30 (CEST, Paris, France)
• Blood: Wednesday 10 June 2026, from 10:00 to 12:30 (CEST, Paris, France)
• All fields: Friday 12 June 2026, from 14:00 to 16:00 (CEST, Paris, France)

Q&A sessions (attendance not mandatory but highly recommended to benefit fully from the training course):

• Tissues & cells: Friday 5 June 2026, from 10:00 to 12:00 (CEST, Paris, France)
• All fields (legislative questions): Tuesday 9 June 2026, from 10:00 to 12:00 (CEST, Paris, France)
• Blood: Tuesday 16 June 2026, from 10:00 to 12:00 (CEST, Paris, France)
• MAR: Thursday 18 June 2026, from 10:00 to 12:00 (CEST, Paris, France)

This training course will be of interest to staff working in SoHO entities who are involved in or responsible for implementing, co-ordinating or improving their QMS. 

Before applying, please check that you meet the following eligibility criteria:

• You work in a Council of Europe member state.
• You are employed in an organisation that handles blood, tissues, cells, or other SoHO for human application.
• You do not work exclusively in the field of advanced therapy medicinal products (ATMPs).
• You are actively involved in or responsible for quality management.
• You have a good level of English (minimum B2).

Please note that the number of available places is limited. Eligible applicants may be subject to a selection process based on the information provided in their application form and on the aim to ensure fair representation of Council of Europe member states.

Eligible applicants who were unable to obtain a place on the previous SoHO-QM training course in 2025 due to oversubscription are invited to apply again and will have priority over new applicants.

Click here to apply 
 

The application phase closes on Sunday 15 March at 23:59 CET!

All applicants will be notified by e-mail of the status of their application no later than 31 March 2026. 

This training course will be repeated in 2027. Applicants who meet the eligibility criteria but cannot be offered a place on this year’s course will be placed on a priority waiting list for 2027.

In addition, the EDQM will organise a specific face-to-face workshop for tissues & cells in the autumn of 2026. If you are interested in participating in this or other future training courses, subscribe to the EDQM newsletter or follow us on social media for registration updates.

Participation in these training courses and workshops is free.

They are co-funded by the EDQM/Council of Europe and the European Commission.

Participating in this training course will require the following time commitments:

• Self-study phase: an estimated minimum of 2-3 hours per week for self-directed study (pre-recorded lectures and additional reading material);
• Live case study and Q&A sessions (please see above for specific dates and times): 
  • approximately 2.5 h at the mandatory live case study session of the chosen SoHO field (either blood, tissues & cells or MAR); 
  • approximately 2 h at the live Q&A session of the chosen SoHO field (optional but highly recommended).

To obtain an attendance certificate, participants must: 

• engage with all mandatory pre-recorded lectures;
• attend the practical case study session of the chosen SoHO field;
• complete the final satisfaction survey at the end of the training course. 

Please note: live sessions will not be recorded and cannot be rescheduled or repeated.