Mapping the hurdles for the clinical applications of Advanced Therapy Medicinal Products (ATMPs)
Summary
Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.
Programme Name
Programme Description
Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.
Call
Detailed Call Description
The proposals should address all of the following activities:
- Map the regulatory, safety and efficacy assessment, manufacturing, organisational and infrastructural needs to improve the translation of ATMPs from preclinical development to clinical use.
- Address the gaps and uncertainties in regulatory and policy aspects pertinent to complex innovative ATMPs.
- Address predictivity of preclinical data for safety and efficacy testing of ATMPs. Improved novel models could be proposed.
- Tackle decision-making processes relating to ATMPs, such as for instance the assessment of their values, the demonstration of the long-term safety and effectiveness, or new pricing and reimbursement frameworks.
- Propose opportunities for an improved knowledge of the regulatory processes among academic ATMP developers.
- Involve regulatory authorities, Health Technology Agencies (HTA), clinicians, ethics committees, and patients, with the aim to ensure higher clinical use of ATMPs. The findings of the project will be available to competent authorities, ATMP developers and manufacturers as well as to national/regional funding agencies.
Financing percentage by EU or other bodies / Level of Subsidy or Loan
100%
Contribution per project: €3,00 million
Eligibility For Participation Notes
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
Programme Category
EU Competitive ProgrammesTotal Budget
€3,00 millionThematic Categories
- Education and training
- Health
- Research, Technological Development and Innovation
- Small-Medium Enterprises and Competitiveness
Eligibility for Participation
- Associations
- Central Government
- Educational Institutions
- Investment Funds
- Local Authorities
- NGOs
- Non Profit Organisations
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- Semi-governmental organisations
- Small and Medium Enterprises (SMEs)
- State-owned Enterprises
- Training Centres
Call Opening Date
12/01/2023Call Closing Date
13/04/2023National Contact Point(s)
Research and Innovation Foundation
29a Andrea Michalakopoulou, 1075 Nicosia
P.O.Box 23422, 1683 Nicosia
Telephone: +357 22205000
Email Address: support@research.org.cy
Website: https://www.research.org.cy/en/
Contact Persons:
George Christou
Scientific Officer
Email: gchristou@research.org.cy
Ioannis Theodorou
Scientific Officer
Telephone: +357 22 205 038
Contact Email: itheodorou@research.org.cy
(Publish Date: 07/02/2023-for internal use only)
EU Contact Point
European Commission, Directorate-General for Research and Innovation
https://ec.europa.eu/info/departments/research-and-innovation_en#contact