|02:00 – 02:30 | Introduction to COVID-19
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
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
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
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
> More information HERE