This in-house training covers the key aspects of clinical investigations and clinical evaluation in accordance with European medical device regulations and the applicable guidelines.

You will learn how to plan, generate, document, and analyze clinical data and how to create a high-quality clinical evaluation report, that is acceptable to regulatory authorities and notified bodies. We will show you how this process fits into the development of a medical device as well as into the post-market aspects of clinical evidence. In addition, you will receive template documents, that you can use to create your own high-quality clinical investigation documentation.

The seminar contents

  • Regulatory Framework
    – Clinical Investigations under the MDR
  • What is a clinical investigation?
    – 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
  • Clinical Project Management
  • Clinical Investigation Plan – Statistics
    – Sample size calculation
    – Data analysis
    – Study report
  • Post-Market Studies
    – PMCF (Post-Market Clinical Follow-up)
    – NIS (Non-Interventional Studies)

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