Medidee is delighted to invite you to this exclusive free online event. It is the opportunity to share with our experts about regulatory constraints in the development of IVD for the COVID-19 infection.

Agenda

02:00 – 02:30   Introduction to COVID-19 – Click here to download the slides
During this presentation, we will provide an epidemiology background of the virus as well as the type of diagnostic tests available.
Speaker: Dr Julianne Bobela

02:30 – 03:20   Requirements of registration under IVDD – Click here to download the slides
This session will feature the classification and registration in Europe as well are the requirements in terms of technical dossier.
Speaker: Dr Silvia Anghel

03:20 – 03:40   COVID-19 IVD in the USA – Click here to download the slides
We will describe the current status of Emergency Use Authorizations and the pathway toward a regular FDA approval.
Speaker: Philippe Etter

03:40 – 04:30   What happens from 26 May 2022, IVDR – Click here to download the slides
We will discuss the new classification concept of the IVDR as well as the new requirements impacting the QMS.
Speaker: Dr Rima Padovani

04:30 – 05:00   Q&A Session
Ask all your questions during the webinar and we will answer them in the end.
Moderator: Dr Silvia Anghel