This two-day course is intended to provide an in depth knowledge and understanding of the main principles and concepts of the Quality part of the Common Technical Document. 

Online conference. This training course is intended for both manufacturers and distributors of medical devices/ in vitro medical devices and will address various questions/issues under the MDR/IVDR.

Online meeting During this session, an overview will be provided of both the overarching European GMO legislation as well as the GMO regulatory framework and procedures in Belgium and how this impacts the Clinical Trial Application process for gene therapy clinical trials in Belgium.

The course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.

Webinar Confirmed speakers: Leen Rasschaert - FAVV-AFSCA Valerie Vercammen - be-sup

Webinar Speakers: Jean-Pierre Engels - General Manager of the Belgian Verification Organisation Jan Depoorter - Expert FMD - Europe at APB Morgane franck - Quality Manager/QP/RP - Movianto