Bio-sample procurement and IVDR transition

Online Seminar

19 April 2023 - 19 April 2023

Online Seminar | The route to acquire samples from biobanks for biomarker exploitation and their IVDR-compliant market introduction.

Date: 19 April 2023 | 9:00 – 12:15  CEST (Amsterdam, Berlin, Paris)

Terms of participation: Read more & apply

Apply for this unique online seminar to learn about the importance of pre-analytics in biomarker discovery, biobank networks for SME’s, and IVDR transition. The online seminar is offered by Integrated Biobank Luxembourg and targets SMEs from North-West Europe and other European regions that develop biomarkers for diagnostics.

The interactive online seminar is aimed at small and medium-sized companies that need access to patient samples for the development of new diagnostics and helps navigate the huge European biobank network BBMRI. In addition, participants will receive information on how to implement the IVDR at the very beginning of the development of new biomarker-based diagnostics in order to safely launch their new products on the European market.

The interactive online seminar is divided into two parts.

In Part I, experts from, Strategiqual and IBBL will present strategies for biomarker validation and commercialization that specifically address the needs of SMEs in three presentations.

In part II, you will have the opportunity to arrange individual 30 minute 1:1 meetings with our experts from and Strategiqual. Please contact the respective experts after successful registration. If you want to receive tailored coaching for strategic biomarker development from IBBL experts, please apply for a Consultancy Service on specific biomarker topics.



9:00 – 9:15

Welcome and introduction of Codex4SMEs project

Biomarker Validation: a critical step for successful Personalised Medicine

Speaker: Monica Marchese, PhD, Translational Biomarker Group Leader  IBBL (Integrated BioBank of Luxembourg)


Pre-clinical biomarker validation is an essential tool to increase the successful exploitation of newly discovered and potentially repurposable biomarkers, to transform them into powerful diagnostic tools, predictors for proper treatments, or successful Cdx.

9:15 – 9:45


The importance of biobank networks for SME’s

Speaker: Annelies Debucquoy, National Node Director, Belgian Cancer Registry, Belgium


An introduction to biobank networks, services and opportunities for collaboration with the largest European biobank infrastructure BBMRI-ERIC from the perspective of the National biobank network in Belgium (, access to samples and data, support and guidance on topics related to ethical/legal aspects of biobanking and how to assure the highest quality of samples.

9:45 – 10:45

Collaboration with SME’s from a hospital integrated biobank point of view

Speaker: Elke Smits, Chief Science & Innovation Officer, University Hospital Antwerp & President, Belgium


This session, will bring some hands-on examples of collaborations between SME’s and biobanks from a hospital integrated biobank point of view. Experiences in merging translational and clinical research within clinical practice both in an academic as industrial setting as well as how to get the best out of collaborations between SME’s and biobanks will be shared.

10:45 – 11:00

Coffee Break

11:00 – 12:00

IVDR transition – How to survive it, from a regulatory point of view ?

Speaker: Delphine Audureau, Strategiqual

  • Regulatory context – transition period
  • Major impacts of IVDR on QMS and products
  • Technical File : focus on clinical evidence
  • Notified body : timelines and cost

12:00 - 12:15

Q&A session

How to apply for services?

  • Check your eligibility:
    • Does your company meets the SME definition of the EU?
    • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
  • Before you apply, read the full Online Seminar Description
  • Complete application form
  • Submit your application and your de minimis self-declaration to IBBL by April 17, 2023 until 12:00 noon CET.

Note: The online training is limited to ten SMEs. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for it.

Note: Our services are in general open to SMEs from all over North-West Europe with preference given to SMEs from one of the participating partner regions (see table of partners) for the services offered.

More information: The online coaching is part of the Interreg NWE-funded Codex4SMEs project. Since 2017, Codex4SMEs has built a large European network in the field of diagnostics and personalized medicine. More than 300 small and medium-sized enterprises have so far benefited from the opportunities offered. These include various events and tailored services that support SMEs in the development of innovative diagnostics.

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