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TOPIC : Strengthening regulatory sciences and supporting regulatory scientific advice

Topic identifier: SC1-HCO-05-2018
Publication date: 27 October 2017

Types of action: CSA Coordination and support action
DeadlineModel:
Opening date:
single-stage
07 November 2017
Deadline: 18 April 2018 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

A large proportion of EC and nationally funded projects in biomedical clinical research is focusing either on the development of novel active substances or on the optimisation of pharmacological treatments, such as novel indications or new treatment/dosing schemes for already registered pharmaceutical products.

For such innovations to achieve full impact, it is necessary to file for new marketing authorisations or request significant changes of the regulatory labelling of existing marketing authorisations to bring improvements from academic research into clinical practice. However, in a majority of cases, the clinical research conducted by researchers in academia does not fulfil regulatory requirements and thus, innovations do not reach the patients in a timely and efficient manner. Researchers often do not allocate enough time and resources and also lack specific relevant know-how to develop strategies enabling successful regulatory Scientific Advice procedures. This is partly because regulatory sciences are not well addressed in medical teaching and training programmes.

Scope:

Proposals should; (i) establish, regularly update and disseminate a comprehensive inventory[1] of existing support activities for regulatory Scientific Advice and Protocol Assistance in Europe such as the Innovation Task Force (ITF[2]) briefing meetings; (ii) analyse the effectiveness of existing support activities and develop a common strategy for training programmes to strengthen regulatory sciences and improve support for successful outcomes from regulatory Scientific Advice and Protocol Assistance based on identified best practices; (iii) support and/or advice for the delivery of corresponding pilot training programmes in an efficient and collaborative manner, and (iv) assess the need for and possibly propose additional mechanisms sustainably supporting academic groups in regulatory Scientific Advice and Protocol Assistance procedures.

A crucial objective is to complement, coordinate and/or harmonise efforts among Member States and at European level in order to support the main target group: academic clinical scientists. The aim is to reach these researchers very early in the planning process for relevant grant applications. A further aim is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualifications.

The relevant stakeholders must be involved in the consortium that will implement this action, in particular all interested national competent authorities (NCAs) alongside academic and industry representatives and associations with relevant experience. NCAs should have clearly identified contact points. Proposals should consider the involvement of the European Medicines Agency (EMA[3]), the Heads of Medicines Agencies (HMA) network[4] and EUnetHTA[5] at European level, in order to ensure (i) the comprehensiveness and validity of analyses, (ii) the feasibility and effectiveness of implemented and implementable activities and (iii) the impact of the whole project.

The Commission considers that proposals requesting a contribution from the EU of between EUR 1.5 and 2 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:
  • Improved knowledge of Regulatory Sciences among academic clinical researchers.
  • Improved success in regulatory Scientific Advice and Protocol Assistance procedures.
  • Improved direct regulatory impact of results from academic clinical research to ensure benefits for patients and healthcare systems.

[1]Already existing initiatives and infrastructures should be integrated efficiently and to the fullest extent

[2]The Innovation Task Force (ITF) is working on matters relating to emerging therapies and technologies. EMA and the EU national competent authorities (NCAs) strengthened their collaboration to support medicine innovation and early development of new medicines by establishing the EU innovation network.

[3]European Medicines Agency: www.ema.europa.eu

[4]The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area http://www.hma.eu/

[5]EUnetHTA Joint Action 3 is a European network of national/regional HTA bodies under the EU Third Health Programme http://www.eunethta.eu/

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
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. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
The same applies to the second stage of the two-stage call for topics SC1-BHC15-2018, SC1-BHC01-2019, SC1-BHC02-2019, SC1-BHC14-2019, SC1-BHC19-2019, SC1-BHC22-2019, SC1-BHC25-2019

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Coordination and Support Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

7. 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. See the Online Manual.

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.

8. Additional documents:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

Submission Service

To access the Electronic Submission Service of the topic, please select the type of action that is most relevant to your proposal from the list below and click on the 'Start Submission' button. You will then be asked to confirm your choice of the type of action and topic, as these cannot be changed in the submission system. Upon confirmation you will be linked to the correct entry point.

To access existing draft proposals for this topic, please login to the Participant Portal and select the My Proposals page of the My Area section.

Type of Action Coordination & support action [CSA]
Topic Strengthening regulatory sciences and supporting regulatory scientific advice - SC1-HCO-05-2018
Guidance on proposal submission: H2020 online manual
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