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 SoHO entities’ activities – from the recruitment and evaluation of potential donors of blood, tissues and cells, 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 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.

This training course will integrate 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 will cover blood, tissues and cells, including the intestinal microbiota and human breast milk.

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 is intended for professionals currently working in SoHO entities who play an active role in quality management. It aims to support SoHO entities in implementing and enhancing 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:

• EDQM guides and Good Practice Guidelines (GPG)
• Personnel management
• Internal audits
• Quality risk management and assessment
• Risk assessment tools (EuroGTPII, MiRCA)
• Change control
• Qualification, validation and verification
• Corrective and preventive actions
• Environmental monitoring
• Biovigilance
• Traceability
• Contingency planning

The working language of the training course is English.

The course will take place from 27 August (self-training) to 13 October 2025.

Please save the dates and times in your calendar:

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

• Friday 12 September 2025 from 10:00 to 11:00 (CEST, Paris, France)
• Friday 19 September 2025 from 10:00 to 11:00 (CEST, Paris, France)
• Friday 3 October 2025 from 10:00 to 11:00 (CEST, Paris, France)

Practical case studies (attendance mandatory):

• Monday 6 October 2025 from 10:00 to 12:30 (CEST, Paris, France)
• Tuesday 7 October 2025 from 10:00 to 12:30 (CEST, Paris, France)
• Wednesday 8 October 2025 from 10:00 to 12:30 (CEST, Paris, France)
• Monday 13 October 2025 from 14:00 to 16:30 (CEST, Paris, France)

The course was 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.

The training is structured around three key components:

• A self-training phase (from 27 August 2025): this self-paced learning period is divided into three modules, each lasting approximately one week. At the beginning of each module, participants will receive access to:
  • pre-recorded video lectures to watch at their convenience;
  • carefully selected reading materials to deepen their understanding of the topics.
• Q&A sessions (from 12 September 2025): held at the end of each module, these live online sessions offer participants the opportunity to engage directly with experts, clarify concepts and discuss the practical implications of what they have studied.
• Practical case studies (from 6 October 2025): live sessions are organised by specific area of expertise and are designed to allow participants to apply the knowledge gained during the self-training phase, explore real-world scenarios and address concrete challenges from their professional context.

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

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

• You work in a Council of Europe member state.
• You are employed in an organisation that handles blood and/or tissues and cells for human application.
• You do not work exclusively in the field of advanced therapy medicinal products (ATMPs).
• You play an active role as a Quality Manager or Responsible Person.
• You have good knowledge of English (minimum level B1).

Considering the interactive nature of this course, the number of places available is limited. Consequently, after pre-registration, participants may be subject to a selection process based on the eligibility criteria listed above, the information provided in their pre-registration form, and the need to ensure fair representation of Council of Europe member states.

 Click here to register 

The pre-registration deadline is 30 June 2025 at 23:59 (CEST, Paris, France).

Pre-registered participants will be notified by e-mail of the status of their application no later than 31 July 2025.

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

What investment will this training require of you?

Participating in this course will require the following time commitments.

Self-training phase: an estimated minimum of 5 hours per module (each module lasts approximately one week), divided as follows:

• approximately 4 hours of self-directed study (pre-recorded lectures and additional reading materials);
• 1 hour for an optional but highly recommended Q&A session (held on Fridays morning).

Practical case studies:

• Attendance at all live sessions is mandatory. Sessions begin on 6 October 2025 and will take place on 6 October, 7 October, 8 October (from 10:00 to 12:30 (CEST, Paris, France) and 13 October (from 14:00 to 16:30 (CEST, Paris, France). Each session will last approximately 2.5 hours.

To gain the full benefit of the course, as well as to receive an attendance certificate, participants must:

• engage with all pre-recorded lectures and reading materials;
• attend and actively participate in all practical case studies sessions;
• join as much as possible the Q&A sessions;
• 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.