Frequently Asked Questions (FAQ) - FTI-Specific aspects

What is the definition of 'on the market'? The point at which a new medical device is on the market is after completion of all clinical trials?

Answer:

“on the market” can be sale of device after completion of clinical trials. But out-licensing after Phase 2 can be considered as market uptake.

Of the max 30 pages, how many pages roughly would you suggest the Implementation section should be?

Answer:

There is not a rule for that.

Clinical Trials Phase 2

Question details:

What would happen, if a Phase 2 is funded, but the company owning the drug candidate decides afterwards to develop the program further through Phase 3 to market (and thus does no longer comply with the 36-months-to-market dogma)?

Answer:

Not reaching this goal will most probably have negative effects for the evaluation of the FTI instrument, but there will be no penalty for the consortium.adidas

Are specific adaptations of existing products that are already marketed in the EU towards ex-EU markets eligible for funding?

Answer:

You should have the EU market in focus. If you can also deliver solutions for additional markets you can do so.

Is the definition of markets restricted to EU markets, or can we also submit proposal that are primarily targeted towards marketing outside the EU (BRIC countries and low income countries)?

Answer:

You should have the EU market in focus. If you can also deliver solutions for additional markets you can do so.

Could you please clarify, 36 months from project start, not project end?

Answer:

Yes, 36 months from project start.

What is the maximum duration of the projects?

Answer:

There is no other limitation than the fact that the time to market-uptake has to be no later than 3 years after the beginning of the project. So the project must not exceed 3 years. Expected are projects of 1-2 years.Men Nike Air Huarache

What is the duration of the project?

Answer:

Although there are no formal limits in the Work Programme, you should note that in terms of impact, the expectation is that initial market take-up of the innovation should happen no later than 36 months after the start of the action.Air Jordan 1

Do you have a dissemination plan template specific for this action (or otherwise)? May you send it to us by e-mail?

Answer:

A dissemination plan is highly dependent on your project! There is not such a template.

Are there any limitations for target markets? Is it needed to be the end user?

Question details:

For a proposal of an Active Pharmaceutical Ingredient (API) manufacturing method development the target is pharmaceutical industry market. Would it be applicable to FTI?

Answer:

There are no limitations for target markets.

It sounded as if there would be a fine/penalty if you not make the projected time-to-market. Is that correct? And if so, what is the penalty?

Answer:

There is no penalty. You must convincingly explain this time to market, which risks you could face and how you could overcome them.

Is there any limitation of number of proposals to submit in FTI? Can an enterprise participate in 2 different FTI projects?

Answer:

No, there is no limitation.

Would a partner that has NOT participated in a H2020 call be considered New? Even if they have applied previously but not been funded?

Answer:

The PIC number must be new and not been used for FP7 projects

What would be the consequence, if the 36 month-to-market timeline cannot be kept?