AI-Powered Signal Detection in Pharmacovigilance
HORIZON-JU-IHI-2025-11-03: Funding for the development and validation of AI-based methods for signal detection in pharmacovigilance. Two-phase procedure: First stage short projects until 09/10/2025, second stage full proposals until 29/04/2026.
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Grant criteria
Funding objective
Development and validation of AI-based algorithms and methods for early and precise signal detection and risk prediction in pharmacovigilance using diverse real-world data sources, as well as the creation of practical guidelines, tools, and training materials for the implementation of these systems by industry, regulatory authorities, and research institutions.
Eligible expenses
- Personnel costs
- Subcontractor costs
- Material costs
Non-eligible expenses
- Cloning for reproductive purposes
- Alteration of the human genome
- Acquisition of real estate
Eligible to apply
- Companies
- Educational Institutions
- Non-profit Organizations
- Founders
Funding requirements
- Fulfillment of the admissibility and participation requirements according to Horizon Europe
- Validation of the legal entity in the participant database
- No grounds for exclusion (e.g., insolvency, fraud)
Documents required for application
- Part A
- Part B
- Annex: Type of Participants
- Evaluation Form
- MGA
Evaluation criteria
- Excellence
- Impact
- Quality and efficiency of implementation
Description
The Innovative Health Initiative (IHI JU) supports in its 2025 work program the development and validation of AI-based methods for signal detection and risk prediction in pharmacovigilance. In a two-stage procedure, consortia consisting of industry companies, research institutions, authorities, and other stakeholders are invited to develop, optimize, and test novel AI algorithms using diverse real-world data sources in real environments. The focus is on the early detection of potential drug risks to efficiently comply with legal requirements such as EU drug safety and GA conformity. The maximum funding amount per project is €8.906 million, with a funding rate of 100% and a project duration of up to 36 months. Eligibility criteria include compliance with Horizon Europe participation conditions, legal validation, and exclusion of insolvency or fraud cases. Applications must be submitted in the first phase as short projects by 09/10/2025 and in the second phase as full proposals by 29/04/2026.
Following AI model development, practical guidelines, tools, and training materials are to be created to facilitate implementation in industry, regulatory authorities, and research institutions. Key evaluation criteria are excellence, impact, quality, and implementation efficiency. Through close collaboration with regulatory authorities such as the EMA, the recommendations for the qualification of AI procedures in pharmacovigilance are intended to contribute and be integrated into detailed approval and monitoring processes. The consortium partners aim to publish evidence-based recommendations, establish common data models, and create best-practice instruments so that patients and citizens benefit from faster and more precise risk communication.