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.

During this session, we will tackle the required departmental (inter)actions for ensuring full GxP compliance. The Marketing Authorization Holder’s responsibilities will be highlighted within the legal framework of the different good practice guidelines (GMP, GDP, GVP…). In collaboration with UPIP-VAPI.

This first session on the “Sources of life sciences regulation” is intended to provide an overview of the main body of the legislation applicable to the placing on the market or making available of medical devices 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.

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.