BASIC WORKSHOP - Validation of diagnostic tests in clinical molecular genetics


From 16 Oct 2014
Until 17 Oct 2014


Biomedical Quality Assurance Research Unit, KU Leuven,Kapucijnenvoer 35, blok D, 3000 Leuven Belgium


Meet experienced people in this field, learn about regulatory requirements (ISO 15189) or how to design a proper validation plan for new molecular genetic tests.

Genetic tests must be validated before diagnostic use to ensure that they perform according to the laboratory's requirements, and test validation is a formal requirement of many accreditation standards including ISO 15189. In this workshop, we will examine the validation requirements of ISO 15189 and address practical ways of meeting them in your laboratory. After the workshop, the participants will be able to...

  • Explain the aims and the importance of validation.
  • Describe the regulatory requirements and recommendations concerning validation and where to find them
  • Write a validation plan:
    • Distinguish between validation and verification
    • Develop a checklist of parameters to be addressed
    • Define key components of validation plan and apply these parameters to a simple example
    • Determine which type of validation is relevant for which test
    • Design experiments to validate a particular test
  • Explain the content, the criteria and the required data for a comprehensive validation report
  • Design and implement appropriate internal quality control to follow-up test performance


For who?

The target audience for this workshop are lab directors, lab technicians, lab scientists and quality coordinators.
Focus is on clinical molecular genetics laboratories.

The workshops are in English.

The number of participants is limited to 30.



Registration closes September 262014 (but note that the number of places is limited). Your registration is not confirmed until full payment is received.

To register, please fill out our registration form.


Registration fee

225 euro for laboratories with a HDI below 0.845
(Albania, Armenia, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Estonia, Hungary, Iran, Latvia, Lithuania, Macedonia, Malta, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Tunisia, Turkey, Ukraine...)

475 euro for laboratories with a HDI above 0.845
575 euro for industrial partners

To check the HDI of your country, please consult the website below:

The registration fee covers documentation, dinner on Thursday evening, plus two lunches and morning and afternoon refreshments. Travel and hotel are at the expense of your laboratory.
It is highly recommended to bring the ISO 15189 accreditation standard for medical laboratories with you. You can order a personalized copy of the ISO 15189 standard via the ISO web store



Registration fee does not include hotel accommodation. Participants should arrange their own accommodation.


Cancellation policy

For cancellation within 6 weeks of the workshop, 50% of the registration fee is due to cover our costs. 
For cancellation within 3 weeks or no-show, registration will be billed in full.

If you are unable to attend you may nominate a replacement participant and transfer the registration any time before the first day of the course.

EuroGentest reserves the right to cancel courses should insufficient registrations be received. 
In that case, you will be informed 8 weeks before the workshop and the full registration fee will be refunded. 

EuroGentest can not be held responsible for any additional financial loss incurred as a result of cancellation.


Contact Information


KU Leuven
Biomedical Quality Assurance Research Unit
Kapucijnenvoer 35, 3000 Leuven, Belgium
Tel : +32 (0)16 34 58 81
Fax: +32 (0)16 34 79 49

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