ACT EU is pleased to announce a hybrid workshop on 3 November 2025:
“Workshop on the Use of External Controls for Evidence Generation in Regulatory Decision-Making”
Registration: Please register via the ACT EU website here: Workshop Registration
The Methodology Working Party (MWP) has identified the need for guidance on the use of external controls as a priority in its consolidated 3-year workplan (2025-2027). This has led to the development of a Draft Reflection Paper on the Use of External Controls for Evidence Generation in Regulatory Decision-Making.
As part of this process, the MWP seeks to engage with external stakeholders to:
– Explore opportunities and potential applications of external controls in regulatory settings
– Discuss methodological challenges in drawing causal conclusions.
Your participation and input will help shape future guidance in this important area.