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EMA – Workshop on the use of external controls for evidence generation in regulatory decision-making held on 3 November 2025: publication of the video recordings and the presentation materials of the event

The need for guidance on the use of external controls was prioritised by the Methodology Working Party (MWP) in its consolidated 3-year workplan 2025-2027 and work has started on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making – Scientific guideline.

As part of the drafting process, the MWP wanted to engage with external stakeholders to explore the opportunities and the potential use of external controls in the regulatory setting and to discuss related methodological challenges to draw causal conclusions.

As stated in the ACT EU multi-annual workplan 2025-2026, a hybrid workshop was organised on 3 November 2025.

The sessions of the event addressed:

  • Session 1 provides an overview of the use of external controls in submission to the EMA and outlines the motivation for the planned reflection paper on the use of external controls for evidence generation.
  • Session 2 focuses on structured pre-planning of the use of external controls and touches upon related challenges as well as outlining the role of the estimand framework and target trial emulation.
  • Session 3 focuses on methodological considerations for various design aspects (for example on metrics to assess the suitability of endpoints, the definition of time zero for time-to-event data and the effect size relevance). The session concludes with a panel discussion.
  • Session 4 reflects on the identification and evaluation of data sources for external controls. Understanding relevant parameters to identify suitable and reliable data sources as well as highlighting new developments are the key focus of this session. 

The presentation materials and video recordings of the event are now available on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2025). EMA – Workshop on the use of external controls for evidence generation in regulatory decision-making held on 3 November 2025: publication of the video recordings and the presentation materials of the event. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/15bv3


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