TOPIC : Regulatory Science Framework for assessment of risk benefit ratio of Nanomedicines and Biomaterials
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Planned opening date:||two-stage 11 May 2016||Deadline: 2nd stage Deadline:||
27 October 2016 17:00:00
04 May 2017 17:00:00
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
The application of nanotechnology and nanobiomaterials has great potential to advance medicine for the benefit of citizens. However, the use of these new technologies poses considerable challenges for assessing the quality, safety and efficacy of the novel nanomedicines and medical devices.Scope:
Proposals should advance the field of medical regulatory science and practice through the development and validation of science based regulatory knowledge and standardisation of innovative technical tools and methods. The intention is to lead to a new and better methodology for pre-clinical and clinical evaluation and help to take appropriate stock of and to apply innovative scientific advances as and when they occur. As relevant, the proposed activities should address sex and gender specific aspects.
Proposals should focus on the development of new regulatory standards and tools that are based on scientific principles that already have a Proof-of-Concept at the laboratory scale.
Where appropriate, proposals should make use of the opportunities for obtaining scientific advice from medical regulatory bodies to support the qualification of innovative development methods.
International cooperation and participation of Member States funding programmes with complementary funding is encouraged to facilitate development of new regulatory science on the global scale.
Established methods, including related equipment, should be brought to Technology Readiness Level 6 and beyond, whereas those based on new concepts are expected to reach TRL 5.
This topic is suitable for international cooperation.
The Commission considers that proposals requesting a contribution from the EU between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
No more than one action will be funded.Expected Impact:
- To reduce the cost of pre-clinical and clinical development for new medical products and therapies, that are based on the application of nanotechnology and nanobiomaterials;
- To reduce the time for innovations to reach the patients;
- To provide a set of tools for more informed risk assessment and decision making;
- To improve standardisation of regulatory practice at the European and international level;
- To establish a close collaboration among regulators, industry, science and patients with regard to the knowledge required for appropriate risk management, and create the basis for common approaches, mutually acceptable datasets and risk management practices;
- To establish a European Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicines, involving industrial, medical, academic, regulatory and patient representative stakeholders;
- To identify within the consortium critical issues for innovative products and establishment of an action plan for further studies;
- To establish links with existing European Infrastructures active in the field, along with relevant European Research Networks;
- To elaborate an action plan for a better integration of the European Union with other regions of the world.
See definition of the 'gender dimension approach' in the introduction of this Work Programme part.
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
- LIST OF COUNTRIES and APPLICABLE RULES FOR FUNDING
described in part A of the General Annexes of the General Work Programme.
Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to Australia, Brazil, Canada, China, Hong Kong &Macau, India, Japan, Republic of Korea, Mexico, Russia, Taiwan).
- ELIGIBILITY and ADMISSIBILITY CONDITIONS
described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme , with the following exceptions:
For single-stage and second-stage evaluations, the threshold for the criteria Excellence and Impact will be 4.
The overall threshold, applying to the sum of the three individual scores, will be 12.
In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except that proposals will be ranked on the basis of individual scores for the Impact criterion before the Excellence criterion.
In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except, when comparing ex aequo proposals of different topics, the proposals will be ranked first according to the position in the topic ranked lists
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- INDICATIVE TIMETABLE for EVALUATION and GRANT AGREEMENT
Information on the outcome of two-stage evaluation:
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- PROVISIONS, PROPOSAL TEMPLATES and EVALUATION FORMS
for the type of action under this topic
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- ADDITIONAL PROVISIONS
Horizon 2020 budget flexibility
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.
- OPEN ACCESS
must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
- ADDITIONAL DOCUMENTS
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
H2020 Work Programme 2016-17: Introduction
H2020 Work Programme 2016-17: Introduction to Leadership in enabling and industrial technologies (LEITs)
H2020 Work Programme 2016-17: Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology
H2020 Work Programme 2016-17: Cross-cutting activities (Focus Areas)
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
The H2020 Work Programme 2016-17 is currently under revision.
An updated version is expected to be published by late July 2016.
The submission service will be opened as soon as the updated version of the H2020 Work Programme 2016-17 is published.
Please consult the updated version of the Work Programme when preparing your proposal.
National Contact Points (NCP) - contact your NCP for further assistance.
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H2020 Online Manual your online guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
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