Event - Workshop - Validation of diagnostic tests in clinical molecular genetics (WP1.8 - WP1.7)

What

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.

WHAT?
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 participants of this workshop will include lab directors, lab technicians, lab scientists and quality coordinators.
Focus is on clinical molecular genetics laboratories.
The number of participants is limited to 25.
The workshops are in English.

REGISTRATION
The registration fee for this workshop is 400 euros per person (500 euros for industrial partners).
The fee covers documentation, restaurant dinner together on Thursday evening, plus two lunches and morning and afternoon refreshments.
Travel and hotel are at the expense of your laboratory.

We are sorry but the maximum number of participants is reached.
However, we give the opportunity to indicate your interest in participating to the workshop on diagnostic validation by filling in this form .
We will contact you if spaces open up in the workshop or if we are considering to organize an additional workshop later on the year.
People are bumped up from the waiting list based on the order in which they sign up.

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. There is no penalty if you send someone else in your place.

ACCOMMODATION
Registration fee does not include hotel accommodation. Participants should arrange their own accommodation.
Due to the fact that the beginning of January is high season, early reservation is highly recommended.
Please contact Mr. Karim Sattout (email: resa-praha-re04@accor.com, tel. +420 266 000 155) to book hotel rooms at the Novotel.
The following website gives a good overview of other hotels in Prague .