Healixia is the Belgian community of all professionals active along the life cycle of medicines, medical devices, in vitro diagnostics & other health related products. Members are active in research & development (including pre-clinical, early clinical and later phases), medical affairs, safety, regulatory affairs and market access in industry, academia, investigator sites, authorities, regulatory bodies or in consultancy.
13 September '22
Webinar: The sources of life sciences regulations - part I: Medical devicesOnline
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.
20 September '22
Healixia session on GxP interactionsAffligem
Save the date!
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…).
30 September '22
Webinar: How to use the IB in de-risking FiH studyOnline
More information will follow soon!
Speaker: Prof. Dr. Jan de Hoon (UZ Leuven)