Introduzione

The performance evaluation of in-vitro-diagnostic devices (IVDs) is an ongoing process, which serves to meet the essential requirements of safety and performance of the In-Vitro-Diagnostics Regulation (IVDR EU 2017/746). In order to demonstrate fulfillment of the intended purpose of a given device, adherence to performance and safety parameters and adequacy to the state of the art, manufacturers need to analyze data and produce a ‘Performance Evaluation Report’, in which they will also demonstrate scientific validity and analytical performance.

This course will set the regulatory scene with which IVDs need to comply, navigate participants through the scientific validity determination, and the performance evaluation and, finally, provide case examples to better understand and see the details of the IVDs performance evaluation process.

Module 1:

  • What is an in-vitro-diagnostic device
  •  What regulations and guidelines apply
  •  IVDR Overview
    • Frame and requirements regarding clinical evaluation.: classification, Post-Market Surveillance (PMS) and Vigilance

Module 2:

  • Scientific validity determination
    • Stages and questions to be answered
      • Establishment of the scientific validity
      • Identification of scientific validity
      • Appraisal and analysis of information
  • Performance evaluation
    • Analytical performance
    • Clinical performance
    • Clinical performance studies
    • Literature

Module 3:

  • Case-study: the clinical evidence report
    • Format
    • Table of contents
    • Frequent pitfalls

The course is addressed to Regulatory Affairs manager/Officers and Specialists, QM-and RM-Manager, Vigilance and PMS-Manager as well as interested circles (medical writers) who want to get a basic understanding of the new framework.

Participant experience

No previous experience is needed. Basic knowledge of the EU IVDR 2017/746 would be advisable.

Online course with Q&A after each module.

Docente/i
Sascha Wettmarshausen
Info

Sascha Wettmarshausen

Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)
Sascha Wettmarshausen was involved in the entire legislative process of the IVDR and in constant contact with the EU Parliament, the Council and the Commission. At the VDGH, Mr. Wettmarshausen is responsible for the entire area of regulatory affairs (7 committees and working groups) and is heavily involved with the European association Medtech Europe (MTE). At MTE he holds the position of the Vice-Chair of the Regulatory Affairs Committee and is involved in 5 further working groups. Furthermore, he was involved in various guidance documents and is in close contact with the German Notified Bodies and other stakeholders.

Stefanie Giesener
Info

Stefanie Giesener

Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, Germany
Stefanie Giesener has continuously worked for various companies in the medical device industry in the field of quality management and regulatory affairs since 1995. Since 2009, she is Head of Quality Management & Regulatory Affairs at the German IVD manufacturer DiaSys Diagnostic Systems GmbH. Beside her responsibilities in these companies, she was already engaged since 1997 in various committees in the German association of IVD manufacturers (VDGH), and in the European association (MedTech Europe) as well. In 2017 she became Member of the board at VDGH. She has already accompanied IVD manufacturers in their migration from the German Arzneimittelgesetz (AMG) to the European In vitro Diagnostic Directive (98/79/EC) and now she is responsible for the implementation of the IVDR at DiaSys.

This online training is divided in 3 modules:

 

Module 1 and 2:  May 11th, 2021 – from 9:30 am to 12:30 pm and from 02:30 pm to 05:30 pm  CET

Module 3:  May 12th, 2021 – from 9:30 am to 12:30 pm CET

 

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants.
Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 1.060,00* (until 13 April 2021)

Ordinary: € 1.270,00*

Freelance – Academy – Public Administration**: € 690,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.


Acquista
Early Bird
Acquistabile fino al 20/04/2021
1.060,00
Ordinaria
Acquistabile fino al 10/05/2021
1.270,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 10/05/2021
690,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Overview of legislative context of IVDs performance evaluation
Risultato atteso
Comprehensive understanding of the obligations of an IVD manufacturer
Risultato atteso
Understanding of the new clinical evidence

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>