Upcoming sessions

  • April 30, 2019: The Clinical Evidence Requirements
  • May 14, 2019: A Workshop on Clinical and Analytical Performance Studies according to the IVD-R
  • June 11, 2019: A practical approach for writing Scientific Validity Reports
  • September 2019: Specific IVD-R Requirements for Distributors and Importers

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Qarad Academy!

The Clinical Evidence Requirements

In the Clinical Evidence session we will address the legislative requirements in terms of clinical evidence as required per the IVDR (Chapter VI, Annex XIII and Annex XIV).  Performance evaluations must be planned, conducted and documented in accordance with Article 56 and Annex XIII. In this practical session we will also introduce the concept of a Performance Evaluation File.

Tools

  • The Performance Evaluation Plan - What type of information is required
  • The Analytical Performance Report - What type of information to use and how to use the template
  • The Clinical Performance Report addressing all possible elements:
    • Literature Review
    • Published Experience gained
    • Clinical Performance Studies
  • The Performance Evaluation Report

A workshop on Clinical and Analytical Performance Studies according to the IVD-R

The training will be focussed on Analytical and Clinical Performance Studies:

  • Explain different performance characteristics required by the IVD-R
  • Applicability of these performance characteristics for different types of IVD products
  • Practical approach to determine the Analytical and Clinical Performance Characteristics with performance studies

Tools

  • Combined Analytical Performance Study Protocol/Report
  • Clinical Performance Study Plan
  • Clinical Performance Study Report

A practical approach for writing Scientific Validity Reports

In the Scientific Validity Session we will address the legislative requirements in terms of scientific validity as required per the IVDR Article 56 and Annex XIII.

Tools

  • Intended Use
    How to build the intended use statement to address all relevant elements required per the legislation
  • Literature Review protocol
    Defining of search terms and literature review criteria
  • Literature Selection Table
  • Literature Review Report
  • Scientific Validity Report - Report build up + focus points

Trainers: Kirsten Van Garsse and Sara Van Wouwe

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