The aim of this training course is to provide tissue establishments (TEs) in Europe with the tools required to successfully implement a quality management system (QMS) for all their processes, from identification of potential donors to processing and storage of the tissues or cells and final preparation for human application.

TEs need to implement a QMS, which must cover all aspects of the activities undertaken, in order to ensure that tissues and cells for human application comply with the applicable technical and legal requirements in a consistent manner. The developments in this sector that have taken place over recent decades have transformed how TEs are organised and how they ensure safety and quality. The concept of quality management (QM) has also evolved significantly within this field, compelling TEs to continually adapt to new requirements.

The European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe plays a central role in the field of tissues and cells for human application by facilitating the exchange of knowledge and promoting the harmonisation of practices throughout Europe. It captures changes in the field in regular updates to the Guide to the quality and safety of tissues and cells for human application, which aims to provide sound information and guidance to optimise quality and minimise the risks of the complex procedures undertaken in this area. The fifth edition of the Guide (2022) includes a set of Good Practice Guidelines for tissue establishments, which consolidates the guidance already defined in existing legislation and scientific guidelines.

With this in mind, the EDQM/Council of Europe is conducting a training course on QM for TEs, intended for QM staff currently working in TEs.

This training course will contribute to supporting TEs in implementing and further developing a robust and risk-based QMS.

The course covers the fundamental aspects of QM in the field of tissues and cells and provides guidance on how to ensure its implementation.

The main topics that will be covered are:

Preliminary programme (available soon)

The course will take place from 2 September to 17 October 2024.

Please save the dates and times of the following live sessions in your calendars:

The course has been prepared by top European experts in the field and will provide participants with the opportunity to build knowledge and competencies by combining weekly online lectures (including pre-recorded videos for participants to watch at their own pace and additional relevant documentation to read) and active participation in live online workshops and debates, which will be divided into specific areas of expertise to better address learning needs.

This training course will be of interest to TE staff responsible for implementing, co-ordinating or improving their QMS.

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

• You reside in a Council of Europe member or observer State.
• You are employed in an organisation that handles tissues and cells for human application.
• You do not (exclusively) work in the field of advanced therapy medicinal products (ATMP).
• You are active in a role as a Quality Manager or Responsible Person.
• You have a good knowledge of English (reading, speaking and listening).

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 above criteria and on the information provided in their pre-registration form. A fair representation of Council of Europe member States will also be ensured.

Please kindly note that in order to receive an attendance certificate upon completion of the training course, participants will need to have:

• watched ALL pre-recorded lectures;
• and attended and actively participated in ALL the live sessions;
• and replied to the global satisfaction survey at the end of the training course.

Registration  

Taking part in this course will require you to commit to an estimated minimum of four hours per week, broken down as follows:

• between 1.30 and 3 hours of self-study time (watching pre-recorded lectures and reading additional training materials);
• 2 hr 30 of live sessions.

It is essential that you watch all the pre-recorded lectures, read all the additional training materials and attend all the live sessions in order to get the most out of the course.