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Web-Seminar: The European In-Vitro Diagnostics Regulation

In-vitro-Diagnistics webinar

[Translate to englisch:]

A cooperation with the networks Interreg North-West Europe Codex4SMEs and Interreg Baltic Sea BiC

The Interreg project Codex4SMEs project plans to improve healthcare by enhanced adoption of personalized medicine in North-West Europe. The objective is to establish a network, which supports SMEs along the value chain of companion diagnostics development.

The BiC (Biomarker Commercialization) platform offers a set of free biomarker commercialization tools to help researchers, SMEs, and technology transfer offices to tackle the highly regulated landscape of in-vitro diagnostics applicable biomarkers.

Exciting presentations await you in the online seminar. novineon CRO has prepared the following topics:

  • Introduction to the IVDR, new risk-based classification
  • The three pillars of performance evaluation for clinical evidence
  • Purpose and requirements of clinical performance studies
  • Requirements and implementation of post-market surveillance

Attendees will receive an exclusive tutorial for the Biomarker Commercialization Guide and the IVDR Guide of the BIC project. To make new contacts, the event offers all participants the opportunity for one-to-one meetings during the networking session.

Save the date:
11.05.2021 | 15:00 – 17:00 CEST

Detailed information about the program can be found here.

Registration link is provided in the program.

We are looking forward to your participation!