During this 90 minutes online session, we will give you an update on Regulatory Affairs topics in Luxembourg. 

This third session on the “Sources of life sciences regulation” is intended to provide the participants with a high-level overview of the pharmacovigilance legislation in the European Union and will include a specific part on the Belgian legislation.

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.

During this workshop, we will work in small groups, where you can discuss different cases, challenges, bumps in the road, best practices,... with peers. Each group will have a lead who is experienced in the RIP role and RIP legislation.

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.

This session is the second part of a two-part training course on the “Sources of life sciences regulation”. It serves to provide participants with a high-level overview of the rules and regulations applicable to medicinal products for human use in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.