Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

Core Objective: To enhance drug safety and improve patient safety through the development and implementation of AI-powered signal detection and risk prediction methods in pharmacovigilance.
Target Recipient Type: Legal entities, including research organizations, universities, SMEs, and large enterprises.
Target Recipient Size: Not explicitly defined, open to various organizational sizes given the collaborative nature of research and innovation actions.
SECTOR-SPECIFIC
Geographic Scope: Primarily EU Member States and countries associated with Horizon Europe, excluding the UK and Canada for funding.
Key Filtering Criteria: Projects must focus on applying Artificial Intelligence to pharmacovigilance, specifically for signal detection and risk prediction. Emphasis is on research and innovation activities that lead to practical guidance and tools.
Grant Frequency and Program Context: This is a specific topic within the Innovative Health Initiative (IHI) Joint Undertaking's Call 11 (HORIZON-JU-IHI-2025-11-two-stage), which is part of the broader Horizon Europe framework. IHI calls are recurring within the Horizon Europe program.

Financial Structure

Total Funding Amount (per grant): 8,906,000.0 EUR.
Minimum Funding Amount (per grant): 8,906,000.0 EUR.
Maximum Funding Amount (per grant): 8,906,000.0 EUR.
Currency: EUR.
Co-financing/Matching Funds: For the second stage of the call, an IHI-specific additional eligibility criterion is a 45% industry contribution, which refers to an in-kind contribution commitment from industry participants.
Eligible Costs: Detailed in Annex G of the Horizon Europe Work Programme General Annexes and IHI JU Work Programme. Specific IHI budget items (e.g., IKOP, IKAA, FC PAID, FC RECEIVED) must be reported using provided templates.
Financial Reporting: Requirements are described in Annex G of the Horizon Europe Work Programme General Annexes.
Audit Requirements: Not explicitly detailed in the provided text but typically part of Annex G.

Eligibility Requirements

Organizational Eligibility

Legal entities are eligible to apply.
Exclusion: Legal entities established in the UK and Canada are not eligible to receive funding for this specific topic.
Consortium Requirement: Participation in a consortium is required, as indicated by references to 'consortium' in budget and application annexes.

Geographic Requirements

Eligible countries are those listed in Annex B of the Horizon Europe Work Programme General Annexes, with the explicit exclusion of the UK and Canada for funding.

Capacity Requirements

Applicants must demonstrate financial and operational capacity as described in Annex C of the Horizon Europe Work Programme General Annexes.

Project Scope Exclusions

The use of AI for Individual Case Safety Report (ICSR) management and processing, as well as periodic reports, is out of scope for this topic.

Application Process

Submission Procedure: Two-stage call.
Application Deadline: 2026-04-29 00:00:00+0000 (latest deadline for second stage).
Planned Opening Date: 2025-06-17.
Submission Platform: Electronic Submission Service via the Funding & Tenders Portal.

Required Documentation

Stage 1 (Short Proposals):
- Part A: Generated by the IT system; general information, participant details, overall budget.
- Part B: IHI JU Proposal template (RIA/SP) – Part B (limit 20 pages).
- Annex: Type of Participants (compulsory Excel template to be uploaded separately).
Stage 2 (Full Proposals):
- Part A: Generated by the IT system.
- Part B: IHI JU Proposal template (RIA/FP) – Part B (limit 50 pages).
- Annex: Annex to the budget and type of participants (compulsory Excel template for IHI-specific budget items and 45% industry contribution).
- Annex: Declaration of in-kind contribution commitment (compulsory Word template for single-stage and second-stage calls).
- Annex: Essential information for clinical studies (compulsory if applicable, otherwise upload a statement declaring no clinical studies).
Optional Annexes:
- In-kind contributions to additional activities (IKAA).
- Ethics (for additional information beyond Part A).

Support and Guidance

Online Manual, Horizon Europe Programme Guide, Funding & Tenders Portal FAQ.
Research Enquiry Service, National Contact Points (NCPs).
Enterprise Europe Network (EEN) for SMEs.
IT Helpdesk for technical issues, European IPR Helpdesk for intellectual property.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk for standardisation advice.
Partner Search tool available to find partner organizations.

Evaluation Criteria

Award Criteria

Award criteria, scoring, and thresholds are described in Annex D of the Horizon Europe Work Programme General Annexes and in the 'Conditions of the Calls for proposals and Call management rules' section of the IHI JU Work Programme.

Expected Impact & Outcomes

Enhanced Patient Safety: Proposals will be evaluated on their potential to improve drug safety through faster and more accurate signal detection and proactive risk management.
AI-Driven Insights: Expected to lead to AI-powered algorithms and methods for highly accurate signal detection and risk prediction.
Efficiency and Streamlining: Contribution to increased efficiency and streamlined processing by automating routine pharmacovigilance tasks.
Policy and Regulatory Support: Evidence generated should support future policies and shape regulations regarding AI use in pharmacovigilance, including alignment with the European Health Data Space (EHDS) and the EU Artificial Intelligence Act.
Practical Implementation: Development of evidence-based and practical guidance, tools, templates, and training materials for implementing AI-powered signal detection and risk prediction systems.

Quality and Trustworthiness

Transparency and Ethics: Adherence to ethical and legal principles for the use of patient-level data and proprietary information, emphasizing transparency, trustworthiness, and compliance with ethical AI frameworks (e.g., ALTAI).
Regulatory Strategy: Presence of a clear regulatory strategy and interaction plan for evidence generation and engagement with regulatory bodies (e.g., EMA).
Stakeholder Engagement: Proactive and early involvement of regional healthcare systems and health authorities.

Compliance & Special Requirements

Regulatory Compliance

Projects must adhere to EU policies and regulations concerning AI for signal detection, including the Regulation on the European Health Data Space (EHDS) and the EU Artificial Intelligence Act.
Engagement with the European Medicines Agency (EMA) is expected, specifically aiming for endorsement of recommendations via the 'Qualification Procedure'.
Applicants are expected to develop a regulatory strategy and interaction plan.

Ethical and Data Protection Standards

Adherence to ethical and legal principles regarding the use of patient-level data and proprietary information is paramount.
Trustworthy AI principles, including human oversight and verification, must follow regulatory frameworks such as the Assessment List for Trustworthy Artificial Intelligence (ALTAI).

Intellectual Property (IP) Policies

The Joint Undertaking (JU) retains the right to object to the transfer or exclusive licensing of intellectual property.

Project Scope Specifics

The focus is on AI for signal detection and risk prediction in pharmacovigilance.
Development of recommendations for 'human-in-the-loop (HITL)' and 'human-on-the-loop (HOTL)' AI in pharmacovigilance signal detection is expected for optimal performance and oversight.
Proactive and early involvement of regional healthcare systems and health authorities in all stages of discussion and decision-making processes is encouraged.

Exclusions

The use of AI for Individual Case Safety Report (ICSR) management and processing, as well as periodic reports, is explicitly out of scope for this topic.

Grant Details