This service offered through the Innovation Office consists on providing scientific/regulatory advice or guidance to academic groups, independent researchers (from academia or hospitals), research foundations, SMEs (if an official certification is provided), patient foundations, non-profit organizations, etc. during any stage of the medicinal product life cycle.
The researchers will have the possibility to request a new follow-up assessment once they reach the milestones mentioned during the initial scientific/regulatory advice.
When to request an Advice through the Innovation office?
As early as possible, ideally even before applying for funding. This will avoid inappropriate developments and will help researchers to use the funding appropriately. This will also have an impact on speeding up the developments, which will allow that new medicinal products get earlier to patients.
Procedure and Schedule
Request for advice
Request for advice from the Innovation Office by sending the following documentation to the mailbox: email@example.com:
- Accreditation as researchers.
- Summary of the product or technology.
- Product development, quality controls, etc.
- Non-clinical studies and results obtained.
- Clinical trials or protocol in their absence.
- Relevant information for the consultation: reports, bibliography, etc.
The more information provided the better.
- Specific questions so that the appropriate assessors within the AEMPS will be involved.
- No fees will be applied.
Validation and evaluation phase
After receiving the request of the Scientific/Regulatory Advice by the applicant, the Innovation Office (through the following mailbox (firstname.lastname@example.org) will validate the request and will start with its coordination.
Depending on the questions raised, the AEMPS will decide whether it is more efficient to answer the questions by Teleconference (TC)/meeting or in writing.
In case of a meeting/TC the Innovation Office will propose possible dates which will be shared with the applicant.
The presentation shall be sent by the applicant one week before the TC/meeting together with the name of the attendees and their position.
TC or face-to-face advice will have a maximum duration of one hour.
Written Evaluation Phase
In the case of a written report, the final report will be sent as soon as possible after the validation of the application.
Post TC/Meeting Phase
It is recommended that the applicant elaborates the minutes of the meeting and sends them to the AEMPS no later than 15 calendar days after the meeting or TC. These minutes are not mandatory, but they can help the researches to collect the indications given by the AEMPS assessors and follow them after the TC or meeting. The AEMPS assessors will review the minutes received by the applicant and a final report will be elaborated and it will be sent to the applicant as soon as possible.
Post National Scientific Advice Phase
It is expected that after the first advice, further interactions will be carried out in order to continue supporting independent researchers and thus boost the research and innovation in our country.