ERAMET was proud to participate in PAGE 2025, held from June 3–6 at the Thessaloniki Concert Hall, where experts from across academia, regulatory agencies, and industry gathered to share and debate the latest in pharmacometrics and model-informed drug development (MIDD).
Set in a collaborative and informal atmosphere, this year’s meeting focused on “MIDD: Innovations, Successes and Lessons Learned,” highlighting how model-based evidence contributes to regulatory decisions, particularly in challenging areas like rare diseases and paediatric populations.
ERAMET’s Contributions
The project was presented during the session: “Credibility assessment of model-informed drug development approaches in paediatric and rare diseases: A review of EMA submissions and assessment reports from 2014 to 2024” by Flora Musuamba Tshinanu. The presentation reviewed how modelling and simulation (M&S) are positioned within marketing authorisation applications, and how their credibility is assessed by regulators.
Other research efforts shared by the ERAMET team included:
- Developing a Harmonising Framework for PK and/or PKPD Scaling for Pain Medications in the Paediatric Population
- Reviewing the use of Modelling and simulation to inform drug development in different therapeutic areas
- Assessing the role of extrapolation in paediatric marketing authorisation applications
- Implications of credibility criteria for model-informed evidence for the evaluation and approval of medicinal products for rare/paediatric diseases
- Quantifying uncertainty in mixed effects modelling
- Operationalising the ERAMET digital research environment
These projects form part of ERAMET’s broader goal of building an integrated repository of regulatory questions, methods, and data that support more consistent and transparent drug development practices across the EU.
📸 Browse the gallery to see which ERAMET team members attended in Thessaloniki and explore the posters presented to dive deeper into specific aspects of the project.
