Source: https://www.fitforhealth.eu/faq-page
Timestamp: 2020-08-09 16:56:59
Document Index: 142161548

Matched Legal Cases: ['Art. 13', 'Art. 10', 'Art. 13', 'Art. 11', 'Art 14', '§13', 'Art. 11', 'Art. 13', 'Art. 14', 'art 4']

Frequently Asked Questions (FAQ) | Fit for Health 2.0
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Clinical Trials Webinar 2017 (19)
Can we use the CT template also for SME instrument phase 2 submissions?
The template 'Essential information to be provided for clinical trials…’ mentions Horizon 2020 single-stage and stage-2 topics for which it is mandatory to complete the template. For respective topics you will have the possibility to upload the completed template as a separate part of your application in the submission system. For all other topics - if a proposal contains a clinical study - you are welcome (but not obliged) to use the structure provided in the template (or an adapted version) and integrate this information in section 1.3 (‘Concept and approach’) or in the relevant work package in section 3.1 (‘Work plan – Work packages, deliverables and milestones’) of part B of the proposal. If required, the table provided in section 1.9 of this template on unit costs can in this case be provided in section 3.4 (‘Resources to be committed’) of part B of the proposal.Off White X Max 98
Can you please give an example of technical personnel that can be included in the calculations for the Unit costs?
In a first step categorize the personnel available within your institution into the three personnel categories (doctors, other medical personnel, technical personnel). There is no fixed rule which personnel are to be allocated to which category. The category ‘technical personnel’ is to be understood as a broad category. However, the information given in the employment contract should be in line with the category the personnel are aligned to. The assignment of the personnel to the three categories should be the same for all subsequent applications which will provide a sound basis of personnel allocation to the three categories for the auditor.AIr Jordan Outdoor Basketball Shoes
How detailed does the Ethics section need to be for an observational trial?
The understanding of ethical concerns should clearly emerge from the proposal. Please check which ethics issues in the ethics issues table (part A/proposal submission form) apply for the activities envisaged in your proposal. The information that needs to be provided in proposal section 5.1 (part B) depends on the ethics issues ticked. The EC guide ‘How to complete your ethics self-assessment’ will exactly guide you through the points to be discussed in proposal section 5.1 for each ethics issue.Pánske topánky
At what stage of proposal submission/implementation is it necessary to provide the protocol?
For each Horizon 2020 clinical study, three mandatory deliverables (Annex 2 of the template 'Essential information to be provided for clinical trials…’) have to be included in the proposal, whereby the first mandatory deliverable (due prior to enrolment of first study subject) requests a final version of the study protocol. Mandatory deliverables: 1.	'First study subject approvals package' (prior to enrolment of first study subject): a. Final version of the study protocol b. Registration number of clinical study c. Regulatory and/or ethics approvals 2.	'Midterm recruitment report‘ (to be scheduled for the time point when 50% of the study population is expected to have been recruited) 3.	'Report on status of posting results' in the study registry(s) (to be scheduled for the time of expected results posting or for the last months of the project, whichever comes earlier) Levis X Jordan 6
Could you please show again the link to the document with the method for calculation of unit costs?
Information on the method for calculation unit costs is available in the template 'Essential information to be provided for clinical trials…’ (section 1.9 ‘Unit costs per patient for clinical trials / studies / investigation’ and Annex 1 ‘Method to determine the unit costs’). The template itself is available in the Participant Portal for relevant topics under 'Call Documents'.Adidas
Must all methodology be in the main body of the proposal or can some of it be in the clinical trial template and just referred to in the proposal?
Must all methodology be in the main body of the proposal or can some of it be in the clinical trial template and just referred to in the proposal or should we assume the possibility that an evaluator will read the main proposal only?
Each section of the clinical trial template must be shortly and concisely described. Information outside the scope of this template will not be taken in account for the proposal evaluation. No other chapters or annexes (containing e.g. complete study protocols) can be added to this template. Section headings should not be changed. In case one or more issues do not apply to a particular study, please briefly explain/ justify. Information provided in this template does not need to be repeated elsewhere in the proposal, but can be referred to.Running Shoes, Trainers, Shorts, Spikes and Clothing
If your clinical trial is in year 5 of a complex 5-year project it's very difficult to fill in the clinical trial form - how do we cope with this when filling in the form?
If your clinical trial is in year 5 of a complex 5-year project it's very difficult to fill in the clinical trial form as (by definition) we don't know exactly what the trial will be (depends on output of research in years 1-4) - how do we cope with this when filling in the form?
When the requested information is currently not available (e.g. a clinical study is planned for a later stage of the project and will be based on data from prior studies) the source of required data should be provided and/or the selection of the applied methodology should be described.Adidas
Can the stage 2 budget be somewhat higher than Stage1?
The full proposal must be consistent with the short outline proposal and may not differ substantially. Changes are not recommended, but if absolutely necessary, they should be clearly explained in the Proposal submission form, section ‘Declarations on stage-2 changes’. The evaluators will determine whether or not these changes are legitimate, and whether or not their insertion compromises the evaluator judgement made at stage 1.Air Jordan I Low
Our legislation foresees exceptions in which several bids for subcontracting are not necessary, is this allowed?
When you involve subsites through subcontracting you will need to follow your purchase procedures. However, our legislation foresees exceptions in which several bids are not necessary, is this allowed?
Beneficiaries must award a subcontract ensuring the best value for money and compliance with the institutional rules for subcontracting and – if the beneficiary is a public body – with national and EU legislation on public procurement.Women's shoes
Are the costs reimbursed through the academic CRO (participating in the project as a beneficiary) or through us as a partner hosting the national ECRIN?
If there is an academic CRO (ECRIN) participating in the project as a beneficiary and we as a national partner are both beneficiary and part of the national ECRIN, are the costs reimbursed through the academic CRO or through us as a partner hosting the national ECRIN?
Each beneficiary should budget its own costs. Costs should be budgeted in line with the project activities each partner is involved in.
In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization.
Would it be possible to get an extension for your project due to e.g. changes in regulatory (EMA) guidance, which may cause a delay?
Timely completion of projects is a declared goal under Horizon 2020. There is no flexibility regarding duration – project extensions can generally not be granted in Horizon 2020. Non-compliance with expected timelines and recruitment estimates (significantly delayed key study milestones) might lead to reduced EU contribution or the termination of the grant agreement. Upcoming challenges must be reported quickly and fully to the EC officers in charge. Exceptional project extensions are based on a case-by-case decision by the European Commission.Air Force 1 Low Upstep BR
How many (pre-clinical) efficacy and safety data needs to be presented under Heading 1.6?
Section 1.6 of the template ‘Essential information to be provided for proposals including clinical trials...’ requests concise information on safety and tolerability of study interventions: e.g. pre-clinical data from in vitro or in vivo studies; data from previous clinical studies; data from (pharmaco)vigilance systems or other sources. Furthermore provide concise information on efficacy of study interventions based on (pre-)clinical data.kabelky, ruksaky
Is there a maximum of budget available for third parties and subcontractors?
Only limited part of the action can be subcontracted (Art. 13 MGA). For subcontracting to CROs: If the clinical study is the main activity of the project, core study expertise cannot be subcontracted. However, certain parts (e.g. GMP manufacturing) might be subcontracted as long as general regulatory expertise is available and the study design, high-level study management and oversight remain as tasks within the consortium. If the clinical study is just a small part of the project, i.e. most of the project is preclinical activity, the study might be subcontracted in its entirety. NIKE AIR HUARACHE
I understand well that unit costs should be the same for all beneficiaries?
The ESTIMATION OF RESOURCES (per task on the basis of the protocol) per clinical study subject is the same for all beneficiaries applying unit costs. However, each beneficiary calculates the costs based on its historical costs. Historical costs mean the costs from the last closed financial year at the time of submission of the proposal.Air Jordan IV 4 Running Shoes
Do you have any suggestions on SMEs that are currently preparing for the preclinical phase?
Should we apply to the classic SME Instrument measures and THEN apply for a clinical trial program like the PM-11? (I'm asking this because it isn't clear whether the Horizon 2020 programmes support preclinical studies.)
HORIZON 2020 also supports preclinical activities. The scope section of each topic clearly describes the expected activities. In order to clarify content-related questions please seek advice e.g. from your National Contact Point.NIKE HYPERLIVE EP
Where can I find a link to current H2020 calls?
Is it possible for a clinical partner to choose the Unit Cost modality, but quantifying also costs for management/of grant office? (Project Manager)
The combination of unit costs per patient and actual direct costs within one clinical study is possible. Exception: For the costs of personnel directly assigned to the conduct of a clinical study, each beneficiary or third party may only choose ONE OF THE FORMS (unit costs per patient or actual direct costs). However, this does not apply to personnel costs for horizontal tasks (e.g. study monitoring or coordination).Odzież damska, buty, sneakersy Nike
Can CROs be a party making available resources against payment?
In Horizon 2020 third parties (i.e. parties not signing the Grant Agreement) receiving payment can be involved as a contractor for other goods and services (Art. 10 MGA), subcontractor (Art. 13 MGA) or as third parties providing in-kind contributions against payment (Art. 11 MGA). Patient data, for example, can be considered as in-kind contribution. A requirement for ‘in-kind contribution against payment’ is a written agreement between the beneficiary and the third party prior to the start of the work. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Wherever possible, third parties should be listed in section B4.2 of the full proposal.Adidas Performance
Please see Guidelines on FAIR Data Management in Horizon 2020 (http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/h...), section 4. ‘Research Data Management plans during the project life cycle’: A funded project must submit a first version of its DMP (as a deliverable) within the first 6 months of the project. The DMP needs to be updated over the course of the project whenever significant changes arise, such as (but not limited to): -	new data -	changes in consortium policies (e.g. new innovation potential, decisions to file for a patent) -	changes in consortium composition and external factors (e.g. new consortium members joining or old members leaving) As a minimum the DMP should be updated and detailed with each periodic report. Furthermore, the consortium can define a timetable for review in the DMP itself. The DMP is intended to be a living document in which information can be made available in more detail through updates as the implementation of the project progresses and when significant changes occur. NIKE AIR MAX
If it is just safekeeping of actual data, any of the big IT companies will likely serve. In general there are (country specific) centers that are helpful or can serve as partners.Marcas de cal?ado, bolsas e vestuário na Spartoo
One approach is to also archive the software to access the data. That said raw data should be in a well described and documented format in such a form that at the very least one can access by reprogramming a tool in the worst case. Thus it is absolutely important to have good metadata and standards which describe standards. In such cases even new software versions can still access, work and use legacy formats (as an example microarray data from the late 90s are still accessible in 2017).Sneaker Release Dates 2019
A DMP should be integrated into the WP (scientific or non-scientific) it fits best. Data management can be part of an already existing task or can form an own task, depending on the relevance of data management in your envisaged project.balerínky
Depending on (i) where the data is coming from, (ii) ‘data intensity’. If the data is OpenData already and from a reliable provider (say data.gov.uk) it is probably fine to just cite this resources. In case of doubt one might want to at least (if copyright etc. allows this) capture the stream or the historical data and deposit this as a dataset. This is definitely possible for not too large data sizes. This has the added advantage, that the analysis based on such data could be reproduced with the exact same ‘primary data’ set. In such case it might thus be useful to archive the underlying data in either a catch all or discipline specific database. Another case might be webservice that provide an analysis on your primary data or provide computational access to a large internal dataset. As such database might go away one might want to capture exact input and output. Some providers experiment with virtual machines and docker images now, which might be a future perspective for long term preservation. Nike Kevin Durant
EDCTP 2 Webinar 05 Aug 2016 (5)
Please proceed with getting documents ready once notification of the award is given by the EDCTP. With regard to the legal entity form – this form has been adapted and it needs to be filled in by all beneficiaries.Nike Magista Obra
EDCTP Webinar (13)
Cofunding (3)
Cofunding can be provided by either public or private legal entities from across the world, including the institution of the lead applicant. Please note however that one of the EDCTP objectives is to promote international research cooperation.Mujer
No, the term cofunding refers to funding for the project in addition to the requested EDCTP funding or awarded grant amount. Cofunding is not required for projects for which EDCTP2 grants are sought (i.e. EDCTP will reimburse 100% of eligible costs) but it is encouraged. If an applicant has secured cofunding for the project, this can be documented at the proposal stage with letters of commitment from other funder(s). Specifically for the current call 'Strategic actions supporting large-scale clinical trials', all organisations that provide cofunding should address an official letter to the Coordinator and these should be submitted by the Coordinator at the Letter of Intent application stage (the electronic form for this call for proposals allows for this). The letter of any cofunder should state the name and organisation of the Coordinator; the title of the EDCTP proposal and the EDCTP call to which the proposal has been submitted. In the Budget and Cofunding section of the application form, the applicant can provide an explanation with details on the committed funds, the timeframe for the commitment and any conditions or restrictions on the funding. Demonstration of major support from other funders at the level of the large-scale clinical trial will be taken into account during the evaluation of the “Impact” criterion. Nike KD
Eligibility for funding (2)
Swiss legal entities are considered entities from a third country not associated to Horizon 2020. This means that Swiss legal entities can participate in EDCTP-funded projects but are not eligible to receive funding and will not count towards the minimum number of legal entities required for a proposal (see the specific eligibility criteria for each call for proposals). For more information on funding by the Swiss government for Swiss participants in projects related to Horizon2020 or Article 185 Initiatives, please see: http://www.sbfi.admin.ch/h2020/index.html?lang=en. Jordan AAA Shoes
There are no specific eligibility criteria in relation to a lead applicant other than the eligibility criteria specified in the call text. Please see the call text for specific requirements. Prior to signing the grant agreement, EDCTP will assess the capacity of the lead applicant’s institution to administer and manage the grant.Crazy BYW PW Boost
General and technical questions (4)
Third-party involvement can be mentioned in the body of the application but currently there are no specific fields requesting this information. All technical questions regarding the application form should be addressed to edctpgrants@edctp.org directly, and for specific questions on the different types of participants to be added in a proposal, please contact the Project Officer (see name and e-mail in the Call Text) in charge of the Call. trail Archives
It is correct that in case of applications in two stages, at the Letter of Intent stage there is no requirement to include figures, charts or other graphics in submitted proposals. In the Letter of Intent stage of this call, the only criteria that are used for the evaluation of the proposals are Excellence and Impact. EDCTP aims to keep the Letter of Intent stage as simple as possible. At the second - full proposal – stage, the quality and efficiency of the implementation in addition to the Excellence and Impact criteria are evaluated. The application form will be equipped with upload functions where applicants can upload supporting documents such as charts. In general, if attachments are required for a specific section of the Letter of Intent or the full proposal, the form will have the necessary upload function, e.g. for the call 'Strategic actions supporting large-scale clinical trials', cofunding letters can be uploaded and attached to the Letter of Intent. Air Zoom Pegasus EM
Pre-clinical development cannot be supported by EDCTP. EDCTP only supports phase I to IV clinical trials. The grant that EDCTP provides, in case a proposal is successful, can be used in part to cover the costs associated with manufacturing a product that is necessary to conduct the clinical trial (phase I and beyond), on the condition that accounting conditions for recognising expenditures are met. Under no circumstances can any (manufacturing) cost incurred before the start of the EDCTP-funded project, be counted as cofunding to the project (in case cofunding is requested). Requests for funding of early pre-clinical work can, for example, be directed to other Horizon2020 programmes. Nike LeBron 16
The ‘Strategic actions’ call supports clinical research activities which are part of a large-scale clinical trial that has the potential to achieve rapid advances in the clinical development of new or improved medical interventions against poverty-related and neglected infectious diseases. In short, the ‘Strategic actions’ call focuses on large-scale clinical trials. The ‘Diagnostics’ call is intended to fund projects that aim to validate the clinical performance and/or implementation of new or improved diagnostic tools and technologies for the detection of any of the PRDs (including as co-infections). Footwear
EDCTP provides funding for research on infectious diseases, especially poverty-related and neglected and/or emergent infectious diseases prevalent in sub-Saharan Africa.Nike Running
Legal and Financial Issues (10)
During periodic reporting, who completes the financial statement of a linked 3rd party: The beneficiary or the linked 3rd party?
See AGA 4.0 p. 151: The linked third parties may declare their costs (in their financial statements; see Article 20.3), if the eligibility conditions set out in Article 6.3 are fulfilled (e.g. actually incurred by the linked third party, necessary for the action, incurred during the action duration, etc.). The costs must be recorded in the accounts of the linked third party. -	Linked third parties may declare costs for all cost categories (as provided for in Article 5), including indirect costs (at the 25% flat rate). -	Each linked third party declares its own costs. The costs of the linked third party must not be included in the beneficiary’s financial statements. Each linked third party has its own financial statements, but these statements must be submitted by its beneficiary (since linked third parties cannot sign them in the IT system; see Article 20). For this purpose, linked third parties must send their signed financial statements on paper to their beneficiary.Børn
For two-stage evaluation proposals, is the total budget specified in the first stage binding for the second stage detailed budget?
Yes. There should be no big deviations to the budget specified in the first stage. But you can make small corrections.
Is there any possibility to apply for 2nd stage when we haven’t applied for the 1st stage of a 2-stage project?
If you mean the second phase of the SME instrument: then yes. Otherwise: no.
Is it possible to include professionals persons (holding TVA) within the personnel budget of the project as in-house-consultants?
You find the rules concerning in-house-consultants in the AGA 4.0 p. 72: Direct personnel costs: Natural persons with direct contract (A.2) 1.2.1 What? This budget category covers typically the costs of in-house consultants and similar persons (i.e. self-employed natural persons) that worked on the action for the beneficiary under conditions similar to those of an employee, but under a contract which is NOT legally the same as for employees. It regards, in particular, contracts qualified as quasi-subordinate work contracts under national law when the conditions under which the work is carried out are similar to those of an employee. Tubular Doom Sock
Are costs made before the start of the project related to the organisation of the kick-of-meeting or website eligible?
No. The only costs eligible before project start are travel costs to the kick-of-meeting IF the travel itself took part within the project duration.
In the periodic report you have to report the work carried out – not what you had planned to do. So yes, you have to at least communicate it within the periodic report. Also it never hurts to let your project officer know what you are doing.Highsnobiety Sneakers
Yes. This is however not the case if you have personnel working 100% on the action. In that case you need to “sign a declaration on exclusive work for the action [ODT format] (one per reporting period), to confirm that the person worked exclusively for the action, either: during the whole reporting period or during an uninterrupted time-period, covering at least a full calendar month within the reporting period.” (see AGA 4.0 p.175) Brands
If there are persons working part time; there is no special treatment compared to full time employees. For temporary workers see AGA 4.0 p.50: “Staff provided by a temporary work agency — A contract with a temporary work agency qualifies typically as a purchase of services (unless the temporary work agency carries out directly some task of the action — in which case it would be considered as subcontracting). Thus, although NOT eligible as personnel costs, the costs can be charged under other budget categories (i.e. D.3 other goods and services or B. subcontracting), if they comply with the eligibility conditions (e.g. best value for money and no conflict of interest; see Articles 10 and 13).”Zoom Kobe Venomenon VI 6
“Unit costs” are a special type of costs. You can find the definition in Article 5.2. Regarding personnel costs you can use the “unit costs” in very few special cases: “Personnel costs for SME owners or beneficiaries that are natural persons not receiving a salary (see Article 6.2, Points A.4 and A.5) must be declared on the basis of the amount per unit set out in Annex 2a (unit costs)” Mujer
Contracting/Subcontracting (11)
Distinction between subcontract and contract for purchase of goods and services
Distinction between a subcontractor and the purchase of goods and Services: is the crucial point whether or not there is a named/numbered task recorded as part of one of the work packages in the DoW. So is it correct, that depending on the way the text is written, the end result might be a subcontract, or might be a contract for goods/services.
The answer can be found in the Annotated Model Grant Agreement (MGA) under Article 10 (Subcontracting, page 128) and Article 13 (Contracts to purchase goods, works or services, page 119). There is also a table comparing those two options (Article 8 pp 113). http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/a... Nike LeBron
What do you consider a department of an institution that issues invoices for the services provided to the other departments of the institute due to the accounting system of the organisation?
What do you consider a department of an institution that issues invoices for the services provided to the other departments of the institute due to the accounting system of the organisation? Is it a third party?
Since the price is charged by a different department of the same legal entity, this is considered internal invoicing.
For the clinical trial in a project the participating centres have been identified as subcontractors to include patients and it is foreseen that an agreement is signed between the sponsor and the participating centre. Is it an obligation to set up a binding procedure to choose the participating centres?
The beneficiaries must base their subcontracts on the ‘best value for money’ or on the lowest price. The best value for money principle does not require competitive selection procedures in all cases. However, if a beneficiary did not request several offers, it must demonstrate how best value for money was ensured.New Balance Popular Collection
In the AMGA it states that in exceptional cases subcontracts are possible between beneficiaries and affiliates. Does this also apply to linked third parties (no affiliate, but legal link)? Does this rule also apply to contracts?
The Grant Agreement does not exclude the possibility that a contract or subcontract is awarded to a third party with a legal link to a beneficiary (which is not an affiliate). However, the selection of the (sub-)contractor must not be influenced by a conflict of interest. See the examples in article 35 of the Annotated Grant Agreement for further information.Chuck Taylor All Star
The rule is that the tasks to be implemented and the estimated cost for each subcontract must be set out in Annex 1, and the total estimated costs of subcontracting per beneficiary must be set out in Annex 2. The actual price may be higher or lower than the estimation in the budget. There is no ‘% tolerance’ foreseen.Nike Air Jordan 1 Retro
Difference Subcontracts / Contracts to purchase goods: When you need to buy a special machine, specially designed for the project, to carry out the work programme, what kind of third party is the supplier? Contractor? Subcontractor? Is the cost of the machine an eligible cost (the full cost or only the depreciation costs of the machine during the project)?
We are afraid it is impossible to answer your question regarding contracts/subcontracts in general without knowing further details. Regarding durable equipment such as machines, only the share of the depreciation costs used for the action (taking into account the equipment’s ‘full capacity’) is eligible. Air Jordans
Is subcontracting possible with the affiliates if they are a 3rd party in the contract through Art 14? The question is if a linked third party is also the usual provider for the use of equipment (but not the same general direction) is it possible to consider them as contractor. Hence, they will make an invoice to the R&D department of the Beneficiary.
By definition, a Linked Third Party does not charge a price, but declares its own costs in line with the eligibility conditions of the Grant Agreement. Therefore, a Linked Third Party cannot be a subcontractor of a beneficiary in the same project.Buty, koszulki, bluzy Męskie
We are not sure if we understand your question correctly. As a general rule, service contracts do not cover the implementation of an action task (as defined in Annex 1), but are necessary for the implementation of a task by beneficiaries themselves. As long as the analytical work performed does not cover the implementation of action tasks, it is considered a service and not a subcontract. สินค้าออกกำลังกายผู้หญิง คุณภาพ ราคาพิเศษ
According to the Annotated Model Grant Agreement, ‘framework contract must (have) be(en) awarded on the basis of best-value-for-money and absence of conflict of interest.’ Moreover, general eligibility conditions such as compliance with the principles of sound financial management, apply. There is no rule that explicitly requires a re-evaluation of the framework contract after several years.Nike Air Max 97
How can you distinct between subcontracts and cost for services as service contracts in research projects: are pure measures of scientific samples belonging to services (if not including scientific work) and in contrast is a R&D contract including research belonging to subcontract? How can you then proceed in a marginal case like blood measurements with a resulting standard analysis which later on will be scientifically evaluated and incorporated into the work action?
To a large extend, the distinction between contracts and subcontracts is project-specific. If the work to be outsourced is defined as an action task in Annex 1 of the Grant Agreement, the related contract is considered a subcontract. In contrast, a contract does not cover the implementation of an action task, but is necessary for the implementation of a task by beneficiaries themselves.Nike Zoom Vomero 14
Linked Third Parties (6)
Implementing tasks as a Linked Third Party is an option, not an obligation. It is up to the potential Linked Third Party and to the consortium do decide if it makes use of this option or includes the organisation as an additional beneficiary. In general, entities performing a substantial part of the work (i.e. tasks) should be beneficiaries, and not linked third parties. Linked third parties should only exceptionally perform a major part of the R&I work.Buty dzieci?ce
Unless otherwise agreed with the Linked Third Party, the beneficiary should transfer the money to the Linked Third Party after it has received it from the coordinator.Обувь
We are not sure if we understand your question correctly. As a general rule, entities performing a substantial part of the work (i.e. tasks) should be beneficiaries, and not linked third parties. Yoanjii
Subcontracting to affiliates is only allowed if there is a framework contract or the affiliate is the usual provider, and the subcontract is priced at market conditions. Moreover, an affiliated entity is not automatically considered a Linked Third Party of a beneficiary, but only if it has been identified as such in the Grant Agreement.Adidas Fotballsko
It can be a Linked Third Party if it is under the ‘direct or indirect control’ of the beneficiary. This means that the large company must (directly or indirectly) hold of more than 50% of the nominal value of the issued share capital, or a majority of the voting rights, or the decision-making powers in the R&D unit.EQT Support Boost
A unit cost is a ‘fixed amount’ per unit which is charged instead of a price which has ‘actually incurred’ by the beneficiary. Regarding SME owners: SME owners not receiving a salary must declare their personnel costs on the basis of unit costs (an hourly rate fixed by the Commission).Zoom Kobe Venomenon VI 6
What happens in the case of third parties of third parties: sometimes Hospitals who are dependent on Health Services have third parties that control the budget of the proposal on a free of charge basis (clause 12). If an institution has the national service as third party that means that the entity is obliged to mention the Hospital foundation as a third party. In this case, how could the entity proceed?
We understand you are referring to third parties of Linked Third Parties. Since Linked Third Parties are subject to the same conditions of eligibility as beneficiaries, they may also declare costs of in-kind contributions provided by third parties.Kids Footwear Online
Is "Action Task" defined in the MGA?
An “action task” is a task of the project described in Annex 1.
Third parties providing in-kind contributions (12)
Which amount will be reimbursed from the beneficiary to its third Party providing in-kind contribution
actual direct costs of third Party for ist infrastructure: 20.000 Euro, actual indirect costs 10.000 EURO (total 30.000 EURO costs); beneficiary will receive from EU only 25.000 EURO (100%+25% indirect costs), does the beneficiary has to pay to the linked third Party providing in-kind contribution at the premises of the Third Party only 25.000 EURO or the complete 30.000 EURO
The beneficiary will reimburse the actual direct costs. Concerning the reimbursement of the indirect cost two different cases my apply: either not taken into account if the in-kind contribution is used in the premises of the beneficiary or taken into account by using the 25% flat-rate if the in-kind contributions are used in the third party’s premises. In this case, the direct costs actually incurred by the third party may be increased by a flat-rate of 25% on those costs. For more details and examples see annotated Grant Agreement Article 11.ЖЕНЩИНЫ
What is the advantage/disadvantage to be involved as third party providing in-kind contribution over linked third-party?
Advantage: no legal link is necessary so also third parties with no legal link are able to provide in-kind contributions Disadvantage: the third parties are not able to do project work on themselves whereas linked third parties are able to do some project workMercurial Superfly CR7 High
Is a third party ‘providing in kind contribution’ in contrast to a ‘linked third party’ never intended to be a research co-operation partner as the other contractual beneficiaries?
Is a third party ‘providing in kind contribution’ in contrast to a ‘linked third party’ according to the existing definition in the AMGA never intended to be a research co-operation partner as the other contractual beneficiaries?
By definition, a third party providing in-kind contributions does not perform any work in the project, so it does not play an active role in the project. Even if it seconds personnel to a beneficiary, this personnel works under the instructions of the beneficiary and not of the third party. In contrast, a Linked Third Party actively carries out work in the project.Nike LeBron
Is it possible to include an industrial company with pure economic interest as ‘Third party in kind contribution’, if it only receives reimbursement of the eligible costs according to the guidelines?
The beneficiaries may declare their costs for paying the in-kind contribution (e.g. the invoice from the third party), but only up to the costs actually incurred by the third party. If an audit shows that the costs declared by the beneficiary are higher than those actually incurred by the third party, the difference will be rejected as ineligible (even if they correspond to the amount actually paid by the beneficiary).Puma
Can a scientist choose any third party in kind contribution partner without having a selection by three offers or a call if the contract will be above 30.000 €?
Can a scientist choose any third party in kind contribution partner without having a selection by three offers or a call if the contract will be above 30.000 €? Regarding existing laws: why is it not obligatory to obtain offers/do a public procurement for any third party in kind contribution?
A selection procedure regarding in-kind contributions by third parties is not required by the Grant Agreement. However, every beneficiary must respect its usual practise (i.e. its internal rules) and comply with the national public procurement law, if applicable. Regarding your question about existing laws, we are not quite sure what you mean. Zoom Kobe 1 Protro
Do you need to provide timesheet for in kind contribution provided by third party free of charge?
If the in-kind contribution is declared as a cost, it needs to be supported by evidence. Therefor, personnel provided as an in-kind contribution free of charge need to be supported by time records or a declaration on exclusive work on the action.womens nike shoes
Regarding the ‘Third party in kind contribution’ definition and the existing tax law: Is it compulsory to add value added tax on the third party partner with in kind contribution?
For information on tax regulations in a specific country, please contact your internal support facilities or tax consultant.
What happens if the costs for third parties (in-kind contribution) is more than the declared cost in the GA, for example by 30%?
The estimated budget (Annex 2) may be adjusted by transfers of amounts between beneficiaries or between budget categories (or both) as long as the project is implemented as described in Annex 1.Air Jordan XIII Melo PE
If an in-kind contribution free of charge is also considered a receipt, which is the benefit of declaring those cost?
A receipt does not necessarily lead to a reduction of the grant, but only if the receipt would produce a profit at the level of the consortium. Please see article 5.3 of the Grant Agreement for further information.Air Jordan 1
If a PhD candidate works part-time for a beneficiary, in an in-kind contribution free of charge, does the beneficiary declare costs of in-kind contributions for this 10% work in "Other direct costs"?
On the in-kind contribution without payment: if a PhD candidate works 10% of his time for a beneficiary, in an in-kind contribution free of charge, does the beneficiary declare costs of in-kind contributions for this 10% work in "Other direct costs"? If yes, how does the beneficiary give the corresponding funding to the university paying for the PhD candidate? Under the "financial support for third parties" section?
‘Financial support for third parties’ is an option which is not applicable in most grants; it has nothing to do with ‘in-kind contributions provided by third parties’. If the in-kind contribution is free of charge (or, as you write, ’without payment’), the university does NOT receive a payment for seconding the PhD candidate. If the university charges the beneficiary for providing the PhD candidate, this is considered an ‘in-kind-contribution against payment’. The beneficiary charges the costs it incurs under the category A.3 (costs of personnel seconded by a third party against payment) and reimburses the university.Cheap Nike Air Max
Are international experts on the Advisory Board Third parties providing in kind contributions? Can we pay them only travel and substance costs or also a fee (at actual costs)?
No, they are not considered as in-kind contributions. If the experts are paid a fee, the relationship would usually be considered a contract or subcontract.Air Force High
How can In kind contributions given by third parties be considered "Receipts"?
In-kind contributions by third parties are only considered receipts if they have been provided by the third party free of charge and specifically to be used for the action, and declared as an eligible cost by the beneficiary. Since the beneficiary receives both a free-of-charge service (by the third party) and a financial reimbursement for the costs borne by the third party, these in-kind-contributions are likely to produce a profit.BRANDS
Approval (Ethics / Orphan drug) (12)
You cannot start any project activity without ethics approval. Ethics approval is not required by the time you submit your proposal (even though you should add any relevant documentation that you already have in place), but is indispensable for the start of activities. If your project is selected for funding and your ethics approvals are not in place yet, you should start the procedure immediately. Once you obtain your ethics approvals, they have to be submitted to the EC. Mens Nike Trainers
Approval needs to granted by EMA, but they offer a lot of assistance - contact them EARLY enough! The FDA approval might help as enabler/ door opener so you might receive Orphan drug designation earlier.Air Force 1
Consortium / Partners / Third Parties (13)
Our company has succesfully passed the 1st stage evaluation of the "H2020-PHC-2015-two-stage" call. Coordinator of the project is a new entity, subsidiary of a big dermatological company, but with no financial data at the moment. We wonder if this financial situation will penalize our stage 2 proposal. Will it be better that the parent company coordinates the project? Explaining that the parent company fully supports the new entity is it enough? Thank you for your help,
Regarding the very limited information given here, we strongly recommend to contact your local National Contact Point for "Legal and Finance" which you can find here: http://ec.europa.eu/research/participants/portal/desktop/en/support/nati... and Financial/1/1/0&+person.last_name/desc If you are in doubt of the financial situation of your company, you can find information on the financial viability self-check here: http://ec.europa.eu/research/participants/docs/h2020-funding-guide/grant... In principle, a change of coordinator is possible, but needs to be very well justified. marka
Beneficiaries must award the subcontracts ensuring best value for money or, if appropriate, the lowest price. The best value-for-money principle does not require competitive selection procedures in all cases. However, if a beneficiary did not request several offers, it must demonstrate how best value-for-money was ensured. For the best price-quality ratio, price is an essential aspect (together with quality criteria, such as technical quality, etc.), but it is not automatically necessary to select the offer with the lowest price. In order to provide a good analysis of the price-quality ratio, the criteria defining ‘quality’ must be clear and coherent with the purposes of the action task that is subcontracted (AMGA, §13, S. 130-135). Producttags : Nike Trainers
I would be more than grateful if you could bring more clarity on subcontractors participation in a clinical trial.
I would be more than grateful if you could bring more clarity on subcontractors participation in a clinical trial. Is it fine to have a certain number of sub-contractors providing clinical recruitment and sample collection?
It is OK to subcontract in general. But it depends on the nature of the tasks. Core tasks cannot be subcontracted, they have to be done by partners. Minor tasks can be subcontracted. If subcontracting, you have to do so via procurement according to your organization's rules. So you cannot name the organization which will be subcontracted in the application. Dame
Can you add a study site at a later stage, i.e. while the CT is running as subcontractor although centers with the same tasks are listed as "partners" in the initial proposal?
Can you add a study site at a later stage, i.e. while the CT is running as subcontractor although centers with the same tasks i.e. conducting the trial, are listed as "partners" in the initial proposal? I guess the question is what are the options to add study site to a running CT, due to recruitment difficulties in the existing sites.
In this case you will have to make an amendment to your grant agreement. I understand that it is getting more difficult to add amendments. I would recommend to plan as conservative as possible and try to include "enough" study sites. We are not sure how high drop-out rates will be handled. Zapatillas Running trail
How should the hospitals recruiting patients be included in the project?
How should the hospitals recruiting patients be included in the project? As subcontractors, partners, service providers? Sometimes at the beginning of the project the list of the hospitals is not available or it is not possible to quantify how much budget they will need to manage the patients. In some case it is necessary to add additional hospitals during the project.
The EC prefers to include study sites as partners. Other options are to subcontract the task (Attention: Only minor tasks can be subcontracted), to include them as In-kind contributions provided by Third Parties against payment or affiliated entitities and third parties with a legal link to a beneficiary. Please refer to slide 29 and 30 of the first presentation (webinar on 18.3.2015) for details. If you need to add study centers during the running project, it depends on how you have included them in your project. If you need additional partners, you have to file an amendment. Men Nike Air Huarache
If we have around 10 different recruiting centers, should we include them as beneficiaries or subcontractors?
Including them as a beneficiary is always the preferred option. However, subcontracting is also possible. This has to be decided individually for each project. The document “Frequently Asked Questions” concerning the Horizon 2020 societal challenge “Health, demographic change and wellbeing” says: Every clinical center can be a beneficiary, and the Commission will not oppose or discourage a large number of beneficiaries for this purpose. Alternative ways to include and reimburse such clinical centers are: (i) As third parties providing in-kind contributions against payment (Art. 11 of the grant agreement). A requirement for this is a written agreement between the beneficiary and the third party prior to the start of the work. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Wherever possible, third parties should be listed in section B4.2 of the full proposal. (ii) As subcontractors (Art. 13 of the grant agreement). In this case, the beneficiary needs to ensure that it complies with the obligation to ensure the best value for money and institutional rules for subcontracting and if the beneficiary is a public body, with national and EU legislation on public procurement. Subcontractors would not usually be named in a proposal given the necessity to undertake the processes required to ensure compliance with the conditions described above. If however such processes have been undertaken in advance, subcontractors may be named in a proposal. (iii) Another option, to participate as ‘linked beneficiary’, is limited to entities that fulfil the specific conditions of Art. 14 of the grant agreement on ‘affiliated entities and third parties with a legal link to a beneficiary’. As these conditions are rather specific, the use of this option is likely to be limited. Mens Eyeglasses
We are a SME in Barcelona. We have experience in several FP7 projects, developing the recruitment database for patient’s data collection. I don't know where to find Institutions and other partners that can be interested in such a partnership.
Please have a look at the FFH website: http://www.fitforhealth.eu/news/new-fit-health-20-partner-search-and-mat....
Does the rule of not subcontracting of core tasks also apply to PHC12, which is SME Instrument? A small biotech or IVD company might not have the capabilities to conduct the CT, so it must be obliged to subcontract them entirely.
The clinical study partners should be partners= beneficiaries whenever possible, this is right; but in PHC12 only SME are eligible for funding. So you either can identify a for-profit CRO that is willing to act as beneficiary (as it is 100% funding rate this is not too bad), or they act as subcontractor. If you are or prefer working with non-profit CROs or with academic partners (university hospitals), they must be subcontracted for this topic. The commission is aware of the dilemma, but confident that the amount of subcontracting will not be a major hurdle for the applicants respectively the evaluation result. Note that in PHC12 like in any other SME instrument topic, the “impact” is even more important than in research & innovation actions, compared to “excellence”. This is: plan and write your project proposal in the best way for your company so that you will be able to become a champion in your market.Hombre
Could you explain a bit more the in kind contribution option against payment? Why can we not use unit cost for this?
That is what EC told us. Sorry we do not know more on that.
What does "too much" subcontracting means? Will it depend only on the evaluators' criteria?
"Too much" is not budget-wise. It is referring to amount and scope of tasks: how central/ crucial is the task you are going to subcontract, compared to the rest of you project?NIKE
Can CROs or recruiting sites be named as subcontractors or is this still subject to the normal subcontracting rules about openness, transparency and cost effectiveness?
No and yes, the task to be subcontracted must be named in the application, but not the name of the subcontractor. For any subcontracting, respect the guidelines on procurement (European, national and of your institution).NUESTRAS MARCAS
What is the opinion of the EC on CRO being a partner in the consortium, with its core task of documentation preparation and quality control and Quality assurance?
It is possible to include a CRO.
Giving the fact any Horizon project involve a consortium maybe it will be useful that participants in this webinar share their email address and key interest for finding potential partners.
There is a partner search tool on the FFH2.0 website which you may want to check out for this purpose: http://mm.fitforhealth.eu
(Unit) Costs / Budget (26)
Funding of Phase 3 or Phase 4 Trials depends on the topic. Some topics might even require later phases of trials as well. Generally, it is possible to claim partial costs. Just make sure to explain how you will cover the remaining costs that won’t be requested from the EC, so it will be clear to the reviewers that you will be able to conduct the CT properly. If you will apply only for partial costs of the study in the scope of the EU project, e.g. for certain study sites but will cover other sites by yourself, you will have to convince the reviewers that data of those sites not included in your project will still be obtained to ensure the feasibility of your project. New Balance Womens Shoes
Yes, please see page 5 of the template. It states: Costs incurred in another currency shall be converted into Euro at the average of the daily exchange rates published in the C series of the Official Journal of the European Union, determined over the corresponding year N-1. If no daily Euro exchange rate is published in the Official Journal of the European Union for the currency in question, conversion shall be made at the average of the monthly accounting rates established by the Commisson and published on their website. Nike Jordan Melo Shoes
Does the EU finance clinical trials other than medicines or devices?
Depends on the topic. They also fund observational studies, if there is a respective topic for that.
Do we understand correctly that it will be allowed that one beneficiary makes a choice for unit costs while other beneficiaries opt for actual costs.
Yes that is correct. Each beneficiary can decide to be reimbursed on basis of unit costs or actual costs for a given clinical study.
How can the unit costs be calculated to "be the same for all members of the consortium” as stated in 1.9 in the template for clinical trials?
In a clinical study involving different countries with very different actual cost levels, (personnel costs of doctors, other medical personnel and technical personnel) e.g. one very high, one very low, how can the unit costs be calculated to "be the same for all members of the consortium” as stated in 1.9 in the template for clinical trials?
For unit costs, the EC foresees different cost levels for different beneficiaries (see table in the template you are referring to column 3 & 4 + example provided in the table). While the total amount per unit can vary between beneficiaries of a consortium, the estimated effort (e.g. time of a doctor spent per unit & amount of resources used per unit) must be the same for one trial, study investigation.Nike News
And what about costs of hospital care that we as a clinical trial sponsor have to pay?
Costs for hospital care that are paid through the national healthcare system/covered by health insurance cannot be charge to the project. Any costs for managing the patient that incur only due to the implementation of your project can be listed in the project budget.sneakers
Are "Research & Innovation Actions" funded 100% or 70%? I am asking concretely on PHC-14-2015.
How to calculate unit costs if the trial is a new process (was not carried out in the past)?
You would have to estimate as good as you can, based on information that is available and that has been recorded in the past. For example, even if that specific clinical trial has not been implemented at your site yet, you should be able to estimate the amount of time that your staff will spend per patient, and use the personnel costs from the last recorded year to calculate the personnel cost per patient included in this new study. All other components, such as consumables etc., should be calculated similarly.Nike
For a given consortium, can one beneficiary use unit costs and another real costs?
How can evaluators assess the unit cost of a specific beneficiary? Do they have guidelines?
As this system is completely new, we have no information as to how the evaluators are briefed. Nevertheless, the calculation of unit costs must be based on recorded & certified figures and the methodology of calculation can be audited in the CFS / by the EC.Air Jordan IV 4 Shoes
How are the unit costs audited and on what extent the details must be identifiable in the accounts of the beneficiary?
How are the unit costs audited and on what extent the details must be identifiable in the accounts of the beneficiary? In other words, can we include in the unit costs that are usually used by hospitals, based on a national tariff system?
Unit costs that are usually used by hospitals may be a very good option for estimates on some components of your unit costs per patient, yes. Please note that costs which are paid for by the national health system cannot be charged to the project though. The calculation of the unit costs (see table in template for clinical studies) will become part of the Grant Agreement (Annex II). The methodology applied in order to calculate unit costs will thus be auditable in the frame of a CFS or an official audit by the EC. The number of actual units claimed during the action must comply with the following conditions: - the units must be actually used during the project - they must be necessary for implementing the action & identifiable and verifiable, in particular supported by records and documentation. adidas yeezy boost 350 v2 zebra
In the scope of PHC14: How detailed should be the submitted budget in such a case?
In the scope of PHC14: as the clinical development is depending on the data that will be obtained in preclinical studies, it will be difficult to have a precise budget to submit. How detailed should be the submitted budget in such a case? How detailed must be the study information that we will submit to H2020?
For PHC 14 (rare diseases) you are advised to contact EMA very early in the process. This is: before submitting stage 2 you MUST HAVE received orphan drug designation, so start contacting EMA today! http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen... http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen...Air Max 90 Woven
Can costs for the experimental drugs be regarded as consumables?
Study medication I personally would put under "other direct costs", but NOT to use in the "unit costs per patient". With the study medication, you have some more steps to get funded: packaging, blinding/ coding, maybe even (GMP) manufacturing. Overall, I would put it as bigger tasks than just as "consumables".Niños
Certificate on Financial Statement and an audit by the EC
For the Certificate on Financial Statement and an audit by the EC, I assume that the beneficiary should be able to specify the unit costs with actual and auditable costs (which origin from the year in which the application was written)? In other words, it cannot be a ballpark figure?
No ballpark figure, no. Numbers must be based on actual costs recorded in last closed accounts of beneficiary, described in detail in the full proposal, and will be assessed by the evaluators.Gifts for Runners
Any costs that will be reimbursed by health care providers/ insurance are NOT eligible for funding via the EU project.
If the project involves more partners from different countries, how can we define the unit cost per patient, considering that each country may have different costs?
Unit costs are partner specific - i.e. you will most likely have different unit costs for each partner.
Can unit costs be used for linked third parties even if the beneficiary they are linked to does not use them?
Yes - they would have to be defined for that linked third party specifically in any case.
Must unit costs be used for ALL proposal or is this just "all patients within this project"?
Unit costs "for all patients at this institution": If one institution participates in several proposals: Must unit costs be used for ALL proposal or is this just "all patients within this project"?
The use of unit costs is a decision that can be made project by project, i.e. one institution can use unit costs in one project and actual costs in another project.Puma
Remark: you may use different approaches (unit costs/actual costs) for one beneficiary for different clinical trials.
Yes, this is true. Unit costs per patients have to be used for ALL patients of a beneficiary, for ONE CT. For a second CT, a second template will be filled-in (make sure to upload in ONE document).Adidas Adilette Slides
In another NCP presentation it says that it gives an exception to this rule for clinical trials - use of unit cost for in kind contribution...?
Is the discussion ongoing or does it give a clear written statement on that?
It is possible to include study centres as 3rd parties providing in-kind contributions against payment. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Please also see question 8 under “Consortium / Partners / Third Parties”.News
Topic-related Questions (7)
Regarding the description of CT in PHC 12 (SME instrument) the same "instructions" apply as to the description of CT in projects addressing other SC1 topics where the template is not mandatory. That means: The template should be used as a checklist or guidance document and all information about the trials that is requested in the template should be provided in the Concept and Approach section of part B of the proposal application. Since projects funded under the SME Instrument should focus on the exploitation of the results (closer to market) this should be considered as well. Since funding of projects with only one SME as partner is possible under the SME-Instrument, it is possible to subcontract the CT (but again: subcontracting rules apply), so in this case the expertise for the CT does not have to lie within the consortium (and this is even not possible in case of only one SME). Adidas Fotballsko
Yes it is correct that for PHC 12, the clinical trial template is NOT mandatory. Info regarding the trial needs to be included in the main template (= Part B).Air Jordan XVII 17
No, not compulsory (mandatory), but EC sees good chances that applicants will present "Concept & approach" where CT is a part of. If you will not conduct a CT in such a topic (*), please reflect on the budget. Of course the budget has been drafted to fund CT as part of the project.Zapatos Nike Mujer
Proposal Structure (7)
Reviewers may have different backgrounds. Therefore the proposal should be written in such a way that it can also be understood and assessed by an evaluator who is not an expert in exactly that scientific field. Pánske oblečenie
Is it possible to just give a few information on the CT in the file that we submit, as our clinical development will be conditioned by the preclinical data that we will obtain?
Yes, you give as many details as you are able to give at that moment. The later the CT will happen, the less details you will know at the time of application. Evaluators need to be convinced, nevertheless, so at least give a vision of your idea.Sneakers
Is part 4 used by the experts for evaluation, or do they have to disregard it (only to assess the capability of the consortium).
Evaluation criteria are applied for chapters 1-3 only. As I mentioned, I would put as much info as possible into the chapters which are not page limited, but you should of course MENTION them in chapter 3 as well (and make reference to the extended versions).Nike Air Max
Can you explain how the different Phases (I to IV) of clinical trials correlate with the TRL scale (1 to 9)? Which Phases of clinical trials can be funded under SME Instrument or Fast Track to Innovation, which both require a minimum TRL of 6?
If we only work on the collection of samples is that it falls within the principle of a clinical trial?
Any work related to the observation of, data collection from or diagnostic or therapeutic intervention on patients is defined for the purpose of using the template and thereby is a CT. Air Jordan Releases 2019
It was said that no major changes should be made between step 1 and step 2. What is considered as major changes?
There is no EC definition of ‘major change’. It is up to the evaluators to decide whether a change is significant or not. In some calls (e.g. LEIT-BIO; SFS ), consortia were asked to list any substantial differences between the 1st stage & 2nd stage proposal (i.e. changes with regards to partnership, budget, approach, workplan) and indicate the reasons in the proposal submission forms.ЖЕНЩИНЫ
At the stage of the application, documents like informed consent form, information sheets, ethics approvals etc. are not available yet. These will often be established during the project. How should one deal with that?
Say as it is – we have this, we are here, but xyz is not yet precisely projectable.
Based on the points made about time planning would you expect the duration of a project including clinical trials to be longer than those under FP7, for example, 6 years instead of 5? Do you think this will be accepted by the Commission?
With regards to “realistic” 6 years might be better than 5 years – so you need to argue accordingly. With regards to credibility and manageability – I would not recommend to prolongate the projects too much. The longer a project is, the more may happen meanwhile which affects results etc. You might rather consider to leave out 1 or 2 Work steps and make the project more tiny and focused.Adidas
What are the consequences if you do not finish your project / clinical study in the time that stands for the particular PHC?
EC told us that a cost-neutral prolongation of EU projects will be more difficult now, compared to FP7. I would say that in worst case, you will not be able to deliver all deliverables that you are committed to (Grant agreement), so that you might lose some of the final funding portion.Nike
Studies without drugs (4)
You are mainly talking about drug studies. Are there any topics where psychotherapy research is mostly recommended?
How would Usability Studies with Medical Devices fit in this scheme?
Please refer to the following presentation explaining that usability study is no clinical study: http://de.slideshare.net/Banderlin/usability-testing-medical-devices.Schuhe
If the therapy does not involve drugs, does the EMA need to be contacted? Is there another relevant organization which should be contacted?
Please see here for non-pharmaceutical products: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen.... In general, we advise you to contact your national competent authority very early - and you might get great support from ethic committees located at your local/ regional university hospitals etc.Adidas sneakers
It would be great if there was some mention of clinical trials which do not involve drugs, such as psychological therapy.
EC does not make big differences here. They clearly say (in the additional template) that they have a very broad definition of CTs - as long as you COLLECT human data (patients/ volunteers). Sure all we are presenting today is applicable for psychological therapy. Whenever a question in the template is not to answer, just write "not applicable".Jordan Shoes
Could you please briefly restate the importance and role of the TEMPLATE?
The template for essential information on clinical trials is mandatory at stage 2 (full proposal) for projects addressing all topics marked with an asterisk in the slides (slides are available on the FFH2.0 website) or indicated on the template. Apparel
If our project foresees a clinical trial to be performed in 4 different enrollment centers across Europe, how many templates should we fill in?
You are supposed to fill in the template for each study, no matter how many study centers will be invlvoved in one study. If you have 3 Studies included in your project, you'll have sections 1-9 filled in for each of those (1.1, ...1.9; 2.1,...2.9 ....), please remember to upload everything as one single document. Running Shoes, Trainers, Shorts, Spikes and Clothing
In the case of multicentered clinical trials, is there one document or one for each pilot?
There is one template consisting of 9 sections. All sections have to be completed for each study of your project. So there will be one single document to be uploaded containing information (section 1-9) for each study. Air Max
Must the template for clinical studies be uploaded together with Part B (included) or as separate PDF in the PPT?
For a recent PHC-2014 call I have uploaded the clinical trial template even while it was not required for the topic. Might be that this is no longer possible for the 2015 topics?
Yes, this was a technical mistake.
You have pointed out PHC11 as a call requesting for clinical trials and indicated with an asterisk. This is not the case in the work program.
Can you please clarify whether the clinical trial approach is mandatory?
In the version of August 2014 it is mentioned: " Single-stage- and stage-2 proposals: The use of this template is mandatory for all clinical studies included in a single-stage- or stage-2 proposal submitted to topics PHC-2, PHC-3, PHC-11, PHC-14, PHC-15, PHC-16, PHC-18, PHC-22, PHC-24, PHC-33 and HCO-62. For these topics, you will have the possibility to upload the completed template as a separate part of your application in the submission system."Kobiety
If the template is not mandatory, can we anyway use it as an annex, to 'save' place in the proposal?
The template can only be uploaded for those topics that are marked accordingly. For all other topics, you can use it as a 'checklist' to make sure you cover all relevant aspects, but cannot upload it. All info needs to be mentioned in the proposal body in those cases.Boots
Is the compulsory annex also used for the evaluation, e.g.: we do not have to repeat what we said, to cut down the number of pages? What level of information is expected at stage 1?
Annexes are to be uploaded with the full proposal, and yes, accessible for the evaluators. You do not have to repeat everything in the proposal body, but can be more concise there and make cross references to the annexes. In stage 1, you must be very brief, as the overall page limit is the same for all proposals, including those that entail clinical study elements.SOCIETY
How/where do you use the protocol in the H2020 application? There is a specific appendix in H2020 about the essential information on clinical trials. How does this relate to the protocol?
Some of the information that is part of the protocol will also appear in the proposal body at places where you describe your study. The protocol as such can be included in a draft version as part of the extra documents that are to be uploaded. The final protocol does not have to be part of the proposal.Best Seller
Recruitment should be very closely monitored. There are different software or web-based solutions available that can indicate recruitment progress at the different sites and on project level. As a coordinator, it is advisable to have access to this information in real time throughout the implementation period of the study. Adidas
Can you advise as to how sponsorship should be dealt with for the clincial trial?
The sponsor should not have significant say in the study protocol so that it will still be seen as “investigator initiated”; also, sponsor shall not have access to raw data/ uncoded data.Mujer
General rules and conditions (3)
Work Programme, Calls and Topics (5)
Where can I find „Health“-related topics in the new Horizon 2020 Programmes?
You can find a series of health-related topics in doing a keyword search under the European Commission > Research & Innovation > Participant portal
Click Here to search for topics by keywords
In addition, see all the open calls of Marie Sklodowska-Curie actions (MSCA) and European Research Council (ERC) grants for individual researchers of any nationality and research teams. The MSCA grants include opportunities for companies and SMEs. The MCSA and ERC grands are not restricted to specific topics.
Does my project idea fit into the relevant call topic?
The idea should hit as exact as possible the wording of the topic. Please contact your National Contact Point to clarify if and where your project idea can be positioned in the Horizon 2020 Health thematic.Nike Hypervenom Phantom III
How can I influence the workprogramme?
You can provide your recommendations through workshops organised by the EC, via ongoing projects, or by contracting the Programme Committee members in all countries of the future consortiumSneakers
Where and how to find information on open calls and all related documents?
All information can be found on the participant portal under http://ec.europa.eu/research/participants/portal/desktop/en/opportunitie... Air Max Shox 2018
What means Horizon 2020 and what are the main opportunities for SMEs?
What means Horizon 2020 and what will be the main advantages for me as an SME?
You can find a detailed description about the participation in the new SME-instrument, in the collaborative projects, as well as information about access to Debt and Equity Financing in the Participants portal.
SME-Instrument (34)
SME-General (1)
Is subcontracting allowed for clinical validation in PHC 12?
Currently we are interested in the Health topic of the SME Instrument. The question we have is that according to the Proposal Template for Phase 2 the core activities of the project cannot be subcontracted. As in PHC12 the core activity is the clinical validation of biomarkers and/or diagnostic devices, does this means that we cannot subcontract the services of a CRO and/or a hospital? Will we have to hire our own doctors and recruit patients? We don't have the intention of becoming a CRO, we just want to commercially exploit our devices.
As opposed to other instruments, the SME instrument (Phase 2) does not have any restrictions when it comes to subcontracting of tasks; see article 13 (p. 370): […] The rules on subcontracting for SME Instrument Ph2 actions are similar to those of the General MGA (see Article 13 General MGA). However, subcontracting is not restricted to a limited part of the action. […] This means that the participating SMEs can subcontract the services of a CRO and/or a hospital without a problem. Air Jordan V Low Supreme
SME-Target group, role of partners & subcontractors (10)
As phase 1 and phase 2 will be considered as different projects, and for different steps in the innovation cycle you might need different partners, yes you can change partners.adidas
Research organisations can only be subcontractors, this is possible in both phases (depending on the topic); it depends on the applicants - what they intend to do during the phase 1 or phase 2, and for which kind of activities they ask for funding.adidas
No problem from where your consortia partners are coming from, provided that the SMEs are established in a EU-member state or associated country; SMEs can be from the same country - but make sure that you can show that the business idea will be disseminated Europe-wide esp. internationally (which might be easier with partners from different member states).NIKE
As long as your company has an application for phase 1 or 2 open, OR has a phase 1 or 2 project running, you cannot apply again. For phase 3 application which is not yet possible, we do not know.Saldos - Entrega gratuita
Innovation has many facets; important ones are of course SUCCESS. How many new products/ technologies have your company launched successfully in the past years, how many patents filed, etc.? If you can show this for past innovations, evaluators might trust you that with your new idea you will be successful again.Nike Laufschuhe und Bekleidung online kaufen
Those SMEs are legally not excluded, but the commission aims at SMEs with HIGH growth potential with at least European market potential; as a start-up or very small company this might be difficult to argue, but most important will be the POTENTIAL. Adidas
SME-Phase 2 (1)
Do we have equal chances to receive phase 2 by applying directly compared to someone going through phase 1 before?
The Commission would like to give higher chances for phase 2 applicants, but of course this depends on the number of applicants. SMEs that have gone through phase 1 first MAY have some advantage when applying to phase 2 - as the Commission likes to have SME go through all the phases (make it properly).Nike Hyperdunk 2017
SME-Financial issues (4)
Can these phase III trials have a much higher real budget versus money requested from the EC (max 3 million)?
A complementary funding is not excluded in the work programme.
Should the costs for Phase 1 be shown in the final report? What is the hourly rate of internal hours in phase 1?
The commission does not ask for financial details, so no hourly rate; just try to reach the 71,000 euro (of which the 70% will be reimbursed as the lump sum).Nike Air Max
Are the 50.000 EUR for subcontracting or for internal personal costs?
The 50.000 EUR can be used for any kind of activity (personnel costs, subcontracting, costs for patent search etc).
When will the lump-sum for Phase 1 be paid?
The lump sum will be paid in two portions - 40% with project start, the rest afterwards, at end of project. The projects that you might get financed as phase 1 and phase 2 are seen INDEPENDENTLY.adidas
SME-Technology readiness levels-TRLs (1)
Which TRL is related to Pre-clinical Studies for a drug?
Pre-clinical studies would be TRL 3 (maybe even lower); for the commission, clinical studies phase I and II is still research (could be TRL 4); so far we have never received such a "translation" of TRLs into medical research but will push for it.Air Jordan IV 4 Running Shoes
SME-Partner description (1)
How extended should the CVs be? Is a 5-6 lines summary sufficient?
For the section 4 talking about the members of consortium, there is no page limit; but for sure you should not go too much into details - and only list experiences relevant for your proposal. Try to be precise and to the point.Air Jordan VII 7 Retro 304775
SME-PHC12-2014/2015 Topic related questions (3)
Isn't PHC-12 funded at 100% in Phase 1 as well?
Yes for the PHC topic, funding rate is 100%
Feasibility assessment: could this be clinical trials?
No, the feasibility assessment in phase 1 is addressing activities like risk assessment, description of bottlenecks, market study, user involvement, IP regime, partner search etc. Clinical studies are activities planned in phase 2.Air Max 2018 Flyknit
What is the definition for a Known biomarker? What do you understand by drug biomarker? How do I need to interpret the and/or in the Health call?
A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NHI Biomarkers Definitions Working Group; 2001)
A valid biomarker is defined as “a biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is an established scientific framework or body of evidence that elucidates the physiologic, toxicological, pharmacologic, or clinical significance of the test results
SME-Submission (4)
Yes. In principle you can directly apply for phase 2; this really depends on how far advanced you are with your market assessment/business plan (for phase 2 you really need some deep insight into your market and competitors!) At the end of phase 1, you will write a short final report. As summary of your findings, you will come up with a conclusion of your feasibility study. This can be: yes it is feasible, but we need xyz budget for conducting this and this --> go and apply for phase 2; if you come to other conclusions (no freedom to operate; no market, market not attractive enough or too complicated,...) you will of course NOT continue the development and not apply for phase 2. Nike Shox TLX 0018
SME-Evaluation (3)
How we should make sure that an evaluator does not have to see our proposal because of confidentiality reasons or competitive reasons?
During the submission process you can name up to 3 people (companies) you wish to exclude; honestly, I would also write it on the cover page of part B.adidas
At least 2 evaluators are planned to evaluate a proposal.
Once Phase 1 has been completed, the results will be somehow evaluated? Or will they be evaluated when presenting the application for Phase 2?
The obtained results in phase 1 will be reported at the end of this phase, but not evaluated once again. However, those results are the basis for the application in phase 2 (and consequently will thus be evaluated when submitting a proposal for phase 2).Nike React Element 55
SME-Reporting (2)
During the implementation of Phase 2, will there be also "reporting periods" with project reviews by the EC as in FP7's Research for SMEs?
Yes, reporting periods such as once a year; the general rules H2020 apply.
You have to provide a report at the end of the project. This will comprise a business innovation plan, recommendations for further, additional activities and your private financing needs as wellNike & Jordan Performance Reviews & Release Date
SME-Business Coaching (3)
How can we become a member of the coaching pool? Is the pool of experts for coaching defined until 2020 or still open for submissions (and if so how)?
EASME is working on a database that is not ready yet. EEN will be included in this.
Business Coaches specialised in a sector are available?
Do we know already how/who will provide the complementary business coaching?
Business Coaches are selected from a pool that is offered by the EC. You will select one of them based on his/her expertise, as of course there are specialists in the particular fields that can assist you. Together with the coach you will work on a coaching plan for phase 1 and coaching will be important also to help you in preparing the application for phase 2. This procedure is intended to be accompanied by the Enterprise Europe Network (EEN).Runners Point
Partner search strategy (1)
How can I advertise my expertise as a partner to larger research organisations/ research projects?
Please use the Fit for Health 2.0 support network and publish a profile on the Fit for Health 2.0 match-making facility
How should the results of EU funded projects be treated and protected?
The type of protection needed depends on the nature of the results. In case Intellectual Property Rights come out as necessary it should be recommended choosing the adequately IPR that suit with the aim of the project and be the most cost efficiently. Grant agreement contents specific rules to follow, for instance, the obligation to adequately and effectively protect the results got (“foreground”) and that is capable to industrial and commercial replication.
SMEs definition involves several criteria. You can test them and see detailed explanation of SME-definition on http://flt.uwe.be/ . This site will allow you to answer an easy question: am I an SME or not ?Nike Jordan Superfly 2017
Fast Track To Innovation (62)
Innovative Medicines Initiative (IMI) (9)
IMI-Projects (4)
Which companies will be partners for these two topics in Call 1?
For topic 1 and 2: Sanofi (Coordinator), Novo Nordisk (Co-coordinator), Eli Lilly(To be confirmed), Other potential partners are still under consideration.Ni?os
Are there ongoing project on personalised medicine and reduction of costs?
The topic of personalised medicine is central to many IMI projects, for an overview, please consult the IMI projects database at http://www.imi.europa.eu/content/ongoing-projectsZapatillas trekking
What will happen with RADAR? It has been taken out of call 11. Can we have an idea of when it will be published?
The RADAR topic is still under discussion between the industrial partners in order to ensure the involvement of other industrial sectors such as the imaging companies.Mężczyzna
Was the subject Multiple Drug Resistance (MDR) treated up to now?
The IMI Project COMBACTE deals with antimicrobial resistance (AMR) http://www.imi.europa.eu/content/combacte
IMI-Participants (2)
The proposers within IMI2 should be at least 3, each from a different country?
According to the Horizon 2020 „minimum conditions“ for participation,(a) at least three legal entities shall participate in an action;(b) three legal entities shall each be established in a different Member State or associated country;c) the three legal entities referred to in point (b) shall be independent of each otherAir Max 90 Hypfuse
I am in the staff of a university hospital that is looking to increase participation in European research programs. Do you have information on which SME from Italy participating in IMI projects in the health sector?
For this question, I would recommend to contact the Italian Delegate to the IMI States Represenatives Group, Giovina RUBERTI (grubertiAT ibc.cnr.it ). Furthermore, you can check all running IMI projects at http://www.imi.europa.eu/content/ongoing-projects IMI-Partnering-Database Partner search for the 1st IMI2 Call via: http://www.imi-partnering.de Аксессуары
IMI-Application (3)
Will IMI funding be applicable for covering costs associated with preparation of an EOI (expression of Interest)?
In Germany only for stage 2, not for the EoI preparation
Are there further details/examples of clinical trials funded through IMI?
I suggest to check the IMI Newmeds project as an example: http://www.imi.europa.eu/content/newmeds
Are there funds available for human clinical trials in Call 9? Can a research organization use IMI funds to contract a clinical trial with a Clinical Research Organization?
Call 9 has unfortunately already closed, but clinical trials can be funded within IMI projects
FP7 (for still running projects) (35)
FP7 related Ethical issues (2)
When patient data are in use, research on animals, stem cells, and others specified on cordis web pages in section ethical issues…
You use the local and actual salary rates. You can use Lump Sums for International Cooperation Partner Countries (ICPC) ICPC got the option being reimbursed: the basis of eligible costs or may opt for lump sums lump sum contribution is defined per country income group in the „list of ICPC economies“:
Economy contribution (€/researcher/year) low income 8 000 €
lower middle income 9 800 €
upper middle income 20 700 €
upper funding limits have to be applied disadvantage of lump sum payment: it is deemed to cover all costs (see also: Guide to Financial Issues, p. 69 ff)
FP7 Financial issues (12)
The magnitude of research funding is usually specified by topic. It depends on the type of projects. Large, medium/small collaborative projects are from € 3 mil up to € 12 mil , the same for NoEAir Jordan 1
If you use the flat-rate, overheads do not need to be justified. If effectively money is left over after covering your overhead this can be used any way. This of course does not apply if you calculate the actual costs!ADIDAS
It does not necessarily depend on the time if someone will be regarded as a subcontractor or as a real partner. It depends on the task one has in a FP7 project. Subcontracting is limited to side-tasks which are not central and crucial for development of the project.Nike Air Max Plus
You only have to show the 3 offers in case of a second level audit by the Commission which can be done up to 5 years after the end of the project (good project documentation is needed!).Niño/a
In principle yes, when the cost cover flights and hotel fees as well as daily allowances only. It is always recommended to get a confirmation from your SO in advance. If it will be a substantial part of the project budget you should think about subcontracting.adidas
Here the internal rules of your organisation apply. As the salary has to be according to the usual practice of the beneficiary it is always very problematic to get an EU-project bonus because this cannot be reimbursed in the project. If the top-up corresponds to more hours work for the beneficiary there is no problem – national labour law is the limit here.Баскетбольные кроссовки
FP7 Project management aspects (10)
How detailed has management to be in an EU FP7 Project?
Management depends on the complexity of the project. Management can be much more detailed in difficult phases of a project. As a co-ordinator one of your tasks is to follow the progress of your project to avoid undue delays. Especially in the first phase of the project you need to monitor the people if they are on the right track. Delays in critical tasks will trickle down and have an effect of the entire project. The focus of all partners in a project has to be on agreeing on objectives. As a co-ordinator you have to pay attention that the partners deliver their reports in time. Delays in reporting leads to a delay of the interim payments for the whole project.Jordan Eclipse Chukka
How does the justification of hours worked on a FP7 project to be documented? Are time sheets required?
Not necessarily. When you have a consistent, high-quality documentation system you can convince your auditor to take this instead of time-sheets. But time sheets are default for most of the organisations, because they are easy to handle. The time recording needs to be signed and countersigned by either the project leader or the hierarchical supervisor. If the time recording system of your organisation is able to do this (e.g. by electronic signatures) then there are no time sheets needed. As the most organisations do not have such a system it is best to print out and sign and have counter-signed the time sheets on paper.Femme
Is the coordinator of a FP7 project responsible for the money spent in the project?
Each partner is responsible for the costs in the Form C and has to keep the documentation in its organisation (including the co-ordinator). But if a partner exceeds the amount of money he is allowed to spend it is the responsibility of the co-ordinator and the management board to monitor that. The co-ordinator is responsible for a good conduction of the project as well as for all the payments to the partners.Nike Series
Is the coordinator of a FP7 project responsible if time sheets form project partners are not correct?
No, that is the responsibility of each partner (Annex II of the Grant Agreement). The partners have to be able to justify the costs of their Form C themselves until 5 years after the end of the project.Nike Hypervenom Phantom II FG Low
Are second level audits for FP7 only targeted to projects or can they also be related to a whole organisation, having several EU-projects?
In FP7 the Commission usually audits 3 projects at a partner's place at once (for large organisations). A Commission' audit is always based on the organisational rules and the systems used in EU-projects. However, the EU COM audit unit has the power and the possibility to involve all other EU projects when they find a logical / consistent error that seems to be “systematic”. Then an extrapolation of the audit findings on all other projects is possible and all other projects may be recalculated.Nike Air Jordan
Can you please tell me what the situation is with reporting in FP7? One of our deliverables should already be completed by Month 5 which has just passed. I have the information for the report. Should this be uploaded and submitted online now or can we wait for the reports of the 1st reporting period, after 18 months?
If you have arranged Month 5 for this deliverable in your Annex 1, this should be uploaded now. Here are some references from the relevant documents:
Guidance notes for reporting: 2.1 During the course of the project, to be submitted:
1. The deliverables identified in Annex I to the Grant Agreement, according to the timetable specified in the Deliverables list.
Guide for Applicants Health Theme: Please note that each deliverable will have to be submitted as a distinct document/report. In order to keep your deliverables manageable, small related deliverables should be grouped as specified parts (equivalent to 'subdeliverables') of a single more substantial deliverable. Progress towards achievement of the full deliverable can then be demonstrated in the periodic reports by reference to the smaller parts. The full deliverable will only be submitted when all parts have been -completed. Ideally this will be at the same date as a periodic report.
Under FP7, how much budget does a coordinator receive for the pre-financing finally, considering the amount reserved for the guarantee funds and the amount that will be kept until the last payment?
One single pre-financing payment Received by the coordinator within 45 days of entry into force of GA, to ensure positive cash-flow during project. The pre-financing equals 160% of average EU funding per period for projects with more than 2 reporting periods, or it equals 60-80% of total EU contribution for projects with 1 or 2 reporting periods. The pre-financing remains the property of the EC until the final payment. Form the amount of pre-financing which depends on the project length, 5% of the total EU funding is transferred to the Guarantee Fund. During project implementation the amount reported in the Form C are paid by the EC (ownership of this money is transferred) – but only up to a limit of 90% of the total EU funding. (10% retention is kept until the final payment – with the final payment the Commission pays 10% as well as 5% are coming from the Guarantee Fund.Dame
When do I have to provide a certificate on financial statements in a FP7 project?
in FP7, every partner who receives more than 375.000 EUR or exactly 375.000 EUR funding has to give a certificate on financial statement (CFS). Together with the financial statement (Form C) which reaches the threshold of 375.000 EUR, the CFS has to be submitted. E.g. in the first period you receive 200.000 EUR funding – you need no CFS. In the second period you receive another 200.000 EUR funding – now you reached the threshold (as 400.000 EUR is more than 375.000 EUR), therefore you have to bring in a CFS. In the next (last) period you receive another 200.000 EUR funding – you don’t need a CFS as you don’t reach the threshold anymore. If you receive less than 375.000 EUR funding in a project, you don’t have to bring in a CFS at all. In projects with less than 2 years if you receive more than/or exactly 375.000 EUR funding, you only have to hand in a CFS at the end of the project. (The same is valid for organisations with a valid Certificate of Methodology, they don’t need a CFS for interim payments, just one at the final payment if they get >= 375.000 EUR funding). Costs for CFS can be reimbursed under Management – Subcontracting.Zoom Lebron XI 11
My question is in relation to direct and indirect cost in FP7. If we allocate some of the time of the Director of the Research Centre, where do we allocate this cost? As direct costs or personnel costs?
Here it depends if the Director receives a salary or not. If the Director does not receive any salary the Marie Curie rates can possibly be taken. Otherwise there has to be made the distinction if his salary is completely in the overhead costs (indirect costs). If so and he wants to get reimbursed hours in the project, these hours have to be taken out of the indirect costs and booked under the direct costs – only then these costs can be reimbursed under personnel costs. I just add here that a complete time recording for the Director is needed too.
Can costs for dinners during FP7 project meetings be claimed on the project?
If it is a project management or a project board meeting and if the dinner is necessary for networking among the consortium partners andis necessary to conduct the project, yes, it is possible to claim it on the project. But it needs to be justified for networking issues. Best advice is to ask the Project Officer in advance if the costs for a common dinner will be covered by the project. It is always good to have an agenda so you really can show that the dinner was a working dinner and not for entertainment. As it is with all costs, the dinner has to fulfil all the eligibility criteria and have to fall under the usual practice of the partner who wants it reimbursed in the Form C (e.g. the organisation only allows the cheapest caterer, then a 5-star expensive catering can never be reimbursed).ACE 17 Purecontrol TF
In FP7, any double funding (e.g. national funding) is forbidden, isn't it?
Yes, it is forbidden. Only complementary financing is allowed.
Any other issues (4)
The standard eligibility conditions for participation, depending on the type of action, can be found in the General Annexes to the Horizon 2020 work programme: http://ec.europa.eu/research/participants/data/ref/h2020/other/wp/2016-2.... Nike
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