EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures

• Date:
  Monday, 24 November 2025 , 09:00 - 18:00 Amsterdam time (CET)
  Tuesday, 25 November 2025 , 09:00 - 16:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The increase in global emergencies and the need to prepare for health threats - from emerging infectious diseases to bioterrorism, radiological, nuclear and chemical threats (CBRN) - advocates for regulatory and scientific pathways for licensing medical countermeasures (MCMs) when human efficacy trials are not feasible or not ethical.

The workshop is focusing on discussing the current regulatory frameworks for the approval of MCMs against these threats based on non-clinical data (usually animal models) as key evidence for the demonstration of efficacy in humans.

It includes a review of the approved vaccines and therapeutic cases to discuss the lessons learnt on the recent advantages and challenges in the use of animal efficacy data as key evidence of efficacy including outcomes and clinical translation of these models.

It aims to address on how to establish, choose and/or improve non-clinical models, including alternative non-animal approaches, that could reliably predict efficacy in humans to support regulatory decision-making for these MCMs in the future. 

Documents

Agenda: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures

Live broadcast

Registration

For virtual active participation, please register via this link:

• EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures