The Real4Reg Consortium hosted its first workshop on November 14, 2023, titled “Challenges in dealing with real-world data for Regulatory Purposes.” The event was conducted online and started with an introduction to the scope and aims of the Real4Reg project and then gave the floor for expert presentations and lively discussions on the topic addressed. Participants of diverse backgrounds, including regulatory agencies, academia, industry, patient representatives, and payers’ representatives, attended the workshop.
The workshop started with a keynote by Denise Umuhire from the European Medicines Agency (EMA), Data Analytics and Methods Taskforce – Real World Evidence. Denise’s presentation introduced the role of real-world data and real-world evidence in medicines regulation, focusing on EMA’s pathways for RWE generation. The presentation also delved into practical experiences outlined in the EMA report, “Real-World Evidence Framework to Support EU Regulatory Decision-Making” (available here), addressing challenges in the use of RWE and identifying opportunities for advancing regulatory decision-making.
The workshop featured presentations from two of our MetReal sister projects: Samu Eränen presented the ONCOVALUE project, its goals and current status, sharing the experiences from the first year of the project in terms of challenges in data harmonisation and mapping. Jan Hillert from More-EUROPA shared his experience within the Big Multiple Sclerosis Data Network, an international network that brings together multiple sclerosis registries and databases to allow joint analyses of very large sets of structured data.
The workshop also included breakout sessions moderated by the Real4Reg team, fostering discussions on data confidentiality, access, and harmonisation.
The Real4Reg Consortium remains committed to promoting dialogue, collaboration, and awareness in the evolving landscape of real-world data for regulatory practices. As the project continues, it seeks to address these challenges collectively and contribute to the advancement of regulatory decision-making through robust real-world evidence