TOPIC : Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: 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)|
11 January 2017 10:28
Switzerland as associated country
From 1 January 2017 Switzerland is associated to the whole Horizon 2020 programme instead of the previous partial association.
This applies to all the grant agreements signed on 1 January 2017 and afterwards.
For more information please see the relevant Note on the Participant Portal.
Topic DescriptionSpecific Challenge:
The development of new biotechnology-based products needs to be complemented with a scientifically valid identification of the potential hazards from these biomaterials to human health and to the environment, together with the monitoring and reduction of the risk that these new technologies pose. Current knowledge is still incomplete and the established methods may be inappropriate for specific materials in view of their eventual deployment. The necessary integration of physical, chemical, biochemical and clinical methods is an open challenge. Hence, future production system engineering requires development of integrated and validated methodologies as basis for an appropriate integrated risk management.Scope:
The development of new biotechnology-based products needs to be complemented with a scientifically valid identification of the potential hazards from these biomaterials to human health and to the environment, together with the monitoring and reduction of the risk that these new technologies pose. Current knowledge is still incomplete and the established methods may be inappropriate for specific materials. Hence, future production system engineering requires validated methodologies as basis for an appropriate integrated risk management. As relevant, the proposed activities should address sex and gender specific aspects.
Projects are expected to initiate and support standardisation of the proposed biomaterials and methods, including methods that will reflect their eventual deployment as part of Advanced Therapy Medicinal Products and/or Medical Devices.
The expected projects should be related to validating, adapting and/or developing a reliable methodology for risk assessment and thorough overarching hazard identification for engineered biomaterials and should address the following areas:
- Comparison and validation of current (and/or development including validation of new) test methods and test schemes, including in vitro and in silico methods, to detect adverse effects from biomaterials to:
- human health including acute and chronic toxicity (oral, inhalation, dermal);
- modelling toxicity behaviour of engineered Biomaterials, including development of ready-to-use predictive models (web services etc);
- the environment; eco-toxicity tests, bioaccumulation, persistence, bioavailability and life cycle impacts onto all forms of biota.
- Relevant reference and/or certified reference materials;
- Management of accidental risk including explosion and massive release;
- Methods for performance assessment of hazard and exposure monitoring systems and on the field detection systems;
- Methods for evaluation of risk reduction strategies and systems.
The implementation of this topic is intended to start at TRL 4 and target TRL 6.
This topic is particularly 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.Expected Impact:
- Development of comprehensive understanding of the properties, interaction and fate of engineered biomaterials in relation to human health and environment;
- Support to policy and decision making concerning biomaterials research in respect to various stakeholders: public authorities, industry, researchers and citizens;
- Validated test methods and schemes for the identification of potential adverse effects from biomaterials and contribution to the future definition of appropriate measures, where needed;
- Support to pre and co-normative activities, such as with reference to the implementation of the REACH regulation;
- Support to good governance in biomaterials research following the safe, integrated and responsible approach as laid down in "Nanosciences and Nanotechnologies: An action plan for Europe".
See definition of the 'gender dimension approach' in the introduction of this Work Programme part.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC and amendments
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:
The criteria, scoring and threshold are described in General Annex H of the work programme.
The following exceptions apply:
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.
The procedure for setting a priority order for proposals with the same score is given in General Annex H of the work programme. The following exceptions apply:
Under 3 (a)
Proposals are first ranked in separate lists according to the topics against which they were submitted (‘topic ranked lists’). When comparing ex aequo proposals from different topics, proposals having a higher position in their respective 'topic ranked list' will be considered to have a higher priority in the overall ranked list.
Under 3 (b)
For all topics and types of action, the prioritisation will be done first on the basis of the score for Impact, and then on that for Excellence.
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
Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
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.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
- Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs.
- Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
- 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
No submission system is open for this topic.
National Contact Points (NCP) - contact your NCP for further assistance.
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
Partner Search Services help you find a partner organisation for your proposal.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
H2020 Online Manual your online guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
IT Helpdesk- contact the Participant Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues