Real4Reg Experts Workshop 2026 – 27th January: “Real4Reg Use Case 1: Lessons Learned on Exploring Real-World Data”

Real4Reg aims to incorporate evidence generated from real-world data (RWD) in optimising and supporting the work of regulatory authorities and health technology assessment (HTA) bodies. One of the most important tasks of the project is sharing the results and their implications for society. Therefore, we have the pleasure to announce our upcoming Experts Workshop, scheduled for January 27th.

This event will focus on data science aspects of using RWD for the characterisation of people diagnosed with amyotrophic lateral sclerosis (ALS) and breast cancer (Use Case 1), such as the implementation of the common data model Observational Medical Outcomes Partnership (OMOP). Here are some program highlights:

  • Use Case 1 Results Presentation: Practical example to illustrate the diversity and heterogeneity of RWD and discussion of the strengths and limitations of OMOP in Real4Reg’s approach.
  • Roundtable Discussion: Exchange of ideas between multiple stakeholder representatives regarding Real4Reg findings and how RWD can be helpful in regulatory decision-making and HTA.

We are looking forward to receiving you!

Agenda

27th January 2026, 11:30-13:00 CET, Online

11:30-11:35 – Introduction

11:35-12:15 – Presentation: Use Case 1 Results and Challenges in OMOP Implementation

  • Vera Ehrenstein (Aarhus University)
  • Mohamed Aborageh (Fraunhofer)

12:15-12:55 – Roundtable Discussion: Real4Reg Use Case 1 Results and Role of RWD in Regulatory Decision-Making and HTA

  • Moderation: Britta Haenisch (BfArM)
  • Piia Rannanheimo (Finnish Medicines Agency, Fimea)
  • Clàudia Roca Herms (Ferrer)
  • Lucía Ortíz (Plataforma de Organizaciones de Pacientes, POP)
  • Daniel Morales (European Medicines Agency, EMA)
  • Ruben van Eijk (University Medical Center Utrecht)

12:55 – 13:00 – Closure