This in-house training covers the requirements for performance evaluation in accordance with the European IVD Regulation and the applicable guidelines. Step by step, you will learn all key aspects and updates related to demonstrating the analytical performance of the in vitro diagnostic device.

How can you assess or confirm fundamental aspects of the performance of an in vitro diagnostic device using clinical performance studies? How can analytical performance studies be substantiated by scientific literature? The structure, design, and conduct of clinical investigations for demonstrating the intended purpose of the in vitro diagnostic device, as well as its parameters for safety and performance, are discussed here in detail.

The seminar contents

  • Regulatory framework
    – Performance evaluation studies under the IVDR
  • Clinical Investigation for IVD: Purpose, Safety, and Performance?
    – Regulatory framework for clinical investigations
    – Ethics committee
    – BASG (Federal Office for Safety in Health Care – Austria)
    – Documents required for the submission of clinical investigations
  • Clinical Investigation Plan
    – Rationale for clinical investigations
    – Study design and definition of endpoints
  • Contraindications, Patient population of the IVD
  • Systematic literature search – databases
  • Performance evaluation report

Costs

1 day in-house training: EUR 3.890 (excluding VAT) for up to 10 participants
including seminar materials and certificate of attendance, plus travel expenses

Your trainer

Priv. Doz. Dr. Ghazaleh Gouya Lechner , is a medical and scientific expert and owner of Gouya Insights KG, a consultancy specializing in strategy, planning, and execution of clinical investigations and clinical evaluations for medical device and biotechnology companies. For several years, she has also lectured at the Medical University of Vienna, including in the master’s program “Clinical Trials.” She is a board-certified specialist in internal medicine, cardiology, and clinical pharmacology, was Medical Director of a major contract research organization, and has been a habilitated lecturer in internal medicine at the Medical University of Vienna since 2015.

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491