Medidee, leading consultancy firm in Europe & USA for Regulatory Affairs, Clinical Affairs and Quality Assurance 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.

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