Date: 26 September to 09 November 2022

Location: Online

Working Language: English


 

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

Each tissue establishment implements a QMS to ensure that tissues and cells for human application comply with technical and legal requirements in a consistent manner, and each QMS must cover all aspects of the activities undertaken by the tissue establishment. Over the last decade, many developments in this sector have led to continual changes in the organisation of tissue establishments and in their approaches to ensuring safety and quality. The concept of quality management (QM) has also evolved significantly within this field, compelling tissue establishments 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 the quality and minimise the risks of these complex procedures. The fourth edition (2019) includes the Good Practice Guidelines (GPGs) for tissue establishments, which consolidate the guidance already defined in existing legislation and scientific guidelines.

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

The main topics that will be covered are:

  • Validation and qualification
  • Good Practice Guidelines
  • Personnel
  • Internal audits
  • Biovigilance
  • Risk assessment tools
  • Documentation
  • Standard operating procedures (SOPs)
  • Microbiological testing

Preliminary programme (available soon)

The working language of the training course is English

The course will take place from 26 September to 09 November 2022.

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

3 October 2022 from 14:00 to 16:30 (CEST, France)

14 October 2022 from 14:00 to 16:30 (CEST, France)

19 October 2002 from 14:00 to 16:30 (CEST, France)

26 October 2022 from 14:00 to 16:30 (CEST, France)

2 November 2022 from 14:00 to 16:30 (CET, France)

9 November 2022 from 14:00 to 16:30 (CET, France)

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

There are only 150 places available in this course.

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

  • You are a resident in a Council of Europe member state.
  • You are employed in an organisation that handles tissues and cells for human application as such.
  • You are active in a role as a Quality Manager or Responsible Person.

After pre-registration, due to the limitation of available places and in order to maintain a fair representation of Council of Europe Member States, participants will be selected to take part in the course based on the information provided in their pre-registration form.


 

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

If you meet the above eligibility criteria, you can pre-register using the following link:

Register now

The pre-registration deadline is 17 July 2022.

After this date, accepted participants will be notified by e-mail.