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Keeping up with Reality and Quality: A Challenge for European Blood Establishments

Blood Quality Management system (B-QM)
Strasbourg, France

Celebrating the 10th anniversary of EU/EDQM co-operation in the field of blood

The year 2020 will mark 10 years of successful collaboration between the European Union and the EDQM in the field of blood, 10 years in which scientific, regulatory, societal, economic and other transversal domains have evolved rapidly. European Blood Establishments (BEs) are required to continuously adapt their Quality Systems (QSs) in light of new developments in these domains, while pursuing the public health objective of ensuring continuity of blood supplies. While many of these developments may be beneficial, BEs often lack the necessary resources or capacity to implement the changes they imply and this can also put the achievement of their objectives at risk. 

BEs have faced, and will face in the years to come, a number of issues arising from recent developments, such as new provisions on data protection, new regulations on medical devices, the globalisation of the market supply of medical devices, material and equipment, as well as demographic changes. These issues have been observed during audits carried out in European BEs, under the aegis of the EDQM's B-QM Programme, and they have been addressed on several occasions as part of the ongoing evaluation of EU blood legislation. It is also anticipated that these issues will affect the QSs of BEs. 

The EDQM, in collaboration with the European Commission, is organising a conference to provide stakeholders with a forum to discuss these challenges. It is essential that stakeholders work together in the early stages to ensure that decision makers are informed about opportunities and threats, and that the measures are taken in order to mitigate risks and ensure the most beneficial outcomes. 

The EDQM and the EU will celebrate 10 years of successful collaboration and, building on the horizon scanning approach, will hold a conference to address the following key topics:

  • the new General Data Protection Regulation (GDPR) and data integrity;
  • demographic changes among blood healthcare professionals;
  • the globalisation of the market supply of medical devices, material and equipment;
  • the new Medical Device (MD) and In Vitro Medical Device (IVD) Regulations; and
  • contingency planning and business continuity. 


Objectives of the conference

The objectives of this conference are to:

  • provide participants with the latest information on each of the topics, as well as their state of play;
  • discuss opportunities and risks in relation to changes and emerging issues; and
  • provide expert opinions and recommendations on mitigating risks.

Ultimately, the aim is to draft recommendations that will support stakeholders and decision makers in developing strategies to address emerging issues and that can serve as a basis for future legislative and technical instruments. Speakers will come from international and European authorities, national authorities, BEs, professional associations and suppliers of medical devices.

Draft programme


Who should attend?

This conference is intended for blood-sector professionals. 


Conference poster session

Deadline for submissions: 31 July 2020

Posters can address subjects related to the topics of the conference and will be on display for the entire duration of the event. Please note that abstracts must not contain any commercial content and only authors attending the conference may submit abstracts.

If you are interested in submitting a poster, please complete the Poster Submission Form and send it to the EDQM Public Relations Division by 31 July 2020. Reception will be acknowledged by e-mail. A Poster Scientific Committee will review the abstracts. The corresponding author will receive a confirmation of acceptance or a notice of rejection by e-mail no later than 14 August 2020.

Please consult the Poster Submission Guidelines.


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