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Real-world-data enabled assessment
for health regulatory decision-making

REALM General Assembly meeting in Brussels

Brussels, Belgium, 19th-20th October 2023

The REALM (Real-world-data Enabled Assessment for Health Regulatory Decision-making) project aims to develop a collaborative framework through which regulatory authorities, software developers, healthcare professionals and policy offers can jointly create and evaluate innovative medical device software. After 10 months of dedicated work on the project tasks, consortium partners met last week at HOEK 38 in Brussels. The meeting was hosted by VITO and gathered 30 project members from 15 partner institutions. The meeting served as a great opportunity to disseminate knowledge and assess REALM's progress.


The project's coordinator, Prof. Michel Dumontier, and co-coordinator, Dr Gokhan Ertaylan, kicked off the meeting by providing an update on REALM's deliverables submitted and milestones reached. Noteworthy achievements include the launch of the REALM project website, the establishment of internal communication channels and a project management platform, and the timely submission of all deliverables including among others the D4.2 Data Management Plan and D4.5 – Authorized access agreements with European Medical Data Pools and DT.

During the first day, each work package's representative shared the progress made thus far and underlined areas requiring input from fellow partners. The liveliest discussions revolved around WP3 (REALM Architecture & Regulatory Toolbox) spearheaded by MINDS and WP4 (RWD & Synthetic Data Repository) led by UM, which largely pertain to RWD & Synthetic Data and REALM's architectural design.

The second day's agenda delved into the Exploitation workshop steered by Dr Patricia Alveen from EURICE, aligning with WP7's themes of Innovation Management, Communication, Dissemination, Networking Training, Exploitation, and Sustainability. This was complemented by "world café" sessions, which encouraged relaxed dialogues on topics such as REALM's real-world applications, AGI in healthcare, and the essence of Living Lab Engagements within REALM. These sessions provided a platform for participants to share and exchange perspectives. The upcoming REALM consortium gathering is scheduled for late May 2024.

In conclusion, the REALM project meeting in Brussels marked a significant progress and collaboration among partners, setting a promising trajectory for the development of innovative medical device software evaluation.