Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence

Last updated: 16.7.2025
Grant

The HORIZON-JU-IHI-2024-06-02-two-stage program, part of the Innovative Health Initiative (IHI) Joint Undertaking, focuses on developing practical guidance for sponsors on using real-world data (RWD) and real-world evidence (RWE). This initiative aims to streamline the use of RWD/RWE in regulatory, Health Technology Assessment (HTA), and payer decision-making processes for innovative medicines and health technologies. By providing structured, evidence-based recommendations, the program seeks to improve patient access to innovations and enhance resource allocation within healthcare systems.

Who is Funded

This section outlines the eligibility criteria for applicants, the geographical scope of the program, and its core objectives. It details which organizations and entities are invited to participate, specifies the regions where project activities should be implemented, and clarifies the primary goals that the program aims to achieve, emphasizing its strategic impact on healthcare innovation and decision-making.

What is Funded

This section outlines the types of projects, thematic areas, and activities eligible for funding, focusing on how real-world data and evidence will be utilized to improve healthcare innovation. It clarifies the specific sectors supported and the typical development stages of projects that align with the program's objectives.

Type and Scope of Funding

This section provides detailed information on the financial support available under the program, including the type of financial instrument, the maximum funding amounts per project, and relevant financial conditions. It clarifies the nature of the financial contribution and any co-financing requirements.

Conditions and Requirements

This section outlines the essential rules, regulations, and specific conditions that applicants and beneficiaries must adhere to throughout the application and project implementation phases. It details requirements for submission, consortium formation, budgetary stipulations, and other key provisions that ensure compliance and effective project execution.

Application Procedure

This section provides a comprehensive guide to the application process, from preparation and submission to evaluation and award. It outlines the procedural steps, required documentation, and the channels through which applications are assessed and decisions are communicated.

This section details the fundamental legal and official documents that establish and govern the HORIZON-JU-IHI-2024-06-02-two-stage funding program. It identifies the primary sources of its legitimacy and outlines the key overarching regulations and policies that shape its implementation and management, ensuring transparency and adherence to established legal frameworks.

Similar Programs

#Real-world data guidance#RWD/RWE evidence#Healthcare innovation funding#Horizon Europe Health#IHI JU grants#Medical device regulation#Drug-device combinations#Regulatory affairs#Health technology assessment#Clinical development funding#European health data#Research and Innovation Actions#Health outcomes#Epigenetics#Consortium funding

Funding Overview

Funding Status

Funding Status:

Closed

Maximum Amount

Maximum Amount:

13,300,000 €

Allocated Budget

Allocated Budget:

13,300,000 €

Open Until

Open Until:

Ongoing

Award Channel

Award Channel:

Framework Programme Call

Region

Region:

European Union and non-EU/non-Associated Countries with specific funding provisions for Horizon Europe projects.

Sectors

Sectors:

Healthcare, Medical Technology, Pharmaceutical Industry, Research and Development, Other

Beneficiaries

Beneficiaries:

Healthcare, Pharmaceutical Industry, Medical Technology

Application Type

Application Type:

Consortium Required

Funding Stages

Funding Stages:

Applied Research, Experimental Development, Prototyping, Pilot Testing, Product Development, Process Optimization, Commercialization, Implementation

Funding Provider

Program Level:

European Union

Funding Body:

Innovative Health Initiative Joint Undertaking (IHI JU)

Managed By:

Innovative Health Initiative Joint Undertaking (IHI JU)

Additional Partners:

European Medicines Agency (EMA), GetReal Institute, REDDIE, More-EUROPA, Oncovalue, Real4Reg, RWE4Decisions, TEHDAS, QUANTUM, CORE-MD, REALM

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