Formations et événements

The use of real-world evidence (RWE) based on RWD can support market access decisions, reimbursement strategies, and comparative effectiveness. To reach the full potential of RWD/RWE, however, certain issues must be addressed. Which source data can be used? What about access and interoperability? How can data quality be guaranteed? Will all healthcare partners accept the RWD/RWE outcomes and incorporate them in their decision process? What are the consequences of the General Data Protection Regulation (GDPR)? During this day, we will focus on the first issue and various accessible databases with Belgian health data will be presented. The data owners explain the databases and the concrete procedure to request the data, if applicable. Some use cases will also be discussed.

Members only!

Since advertising of medical devices is a topic on which there is little legislation at European level, there are significant differences between jurisdictions. We will focus on the general national (Belgian) legal and regulatory framework applicable to advertising, and more specifically the promotion of medical devices in Belgium. Special attention will also be paid to the hot topic of advertising through social media and the new EU requirements regarding claims. This presentation is primarily intended for those who advertise medical devices in Belgium/the EU

Qu'est-ce qui donne envie à votre auditoire de vous écouter? Comment inspirer et motiver votre public? Comment faire bouger les personnes?

In this session, we will discuss the impact of the Medical Devices Regulation (EU) 2017/745 (MDR) on Class I medical devices, including Class Im (measuring function), Class Is (sterile) and Class Ir (reusable surgical instruments) products. The training course is intended for both manufacturers and distributors of Class I medical devices and will look at the new obligations that the MDR has brought for their businesses. Both pre-marketing (such as registration, verification and reporting) and post-marketing (such as post-market surveillance, vigilance, market surveillance and traceability) obligations will be addressed. New obligations for Class I medical devices under the new (i.e. post-MDR) Belgian legislation will also be briefly covered.

The In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) is set to significantly reshape the way IVDs are being marketed in the EU and will significantly amend the applicable legal framework from 26 May 2022. This presentation will identify the changes brought by the IVDR and the obligations of economic operators as from 26 May 2022, both in the pre-marketing and post-marketing phases, with tips and tricks to ensure compliance during and after the transition period. This presentation is primarily intended for those manufacturing or distributing IVDs in the EU.