Pilot II - A New Support Activity
With Pilot II we aimed to improve the regulatory knowledge of academic health researchers and to enhance regulatory scientific advice.
From 1-30 September 2021, we temporarily opened a one-stop-shop communication platform for Spanish academia exclusively.
This was a quick and informal way for clinical researchers to get answers to their regulatory questions and to help improve future scientific advice for European academic health researchers.
Pilot II was performed by our Spanish consortium partner AEMPS (Spanish Agency of Medicines and Medical Devices). This service was free of charge.
Pilot II Concept
The development of this novel support activity was based on comprehensive survey data that were collected within the course of the STARS project. We surveyed a wide scope of stakeholders regarding different aspects on regulatory awareness, knowledge, and support. In total, we analysed data from 449 academic health research groups, 88 health research centres, 40 funding bodies and 21 NCAs with a view to best practices and gaps in the level of regulatory awareness, knowledge, attitude and approaches in relation to academic clinical research and regulatory science.
Comprehensive data analysis revealed that there the academic community has a requirement for tools to improve the communication between regulators and academia, and that a timely response is probably the most remarkable need.
Based on these findings, Pilot II was developed as a one-stop-shop platform that enables academic researchers to access general content on regulatory aspects but also ask some quick questions.
The objective of this platform was to facilitate an informal exchange of information and provide basic regulatory guidance in the development process, complementing and reinforcing existing formal regulatory procedures (like the National Scientific Advice and Innovation Offices). This service was free of charge.
To use this service, researchers were able to contact AEMPS by filling in a PDF contact form or by sending an e-mail. For further details proceed to the Communication Board.
Pilot II Invitation
Download our invitation letter in English or in Spanish to learn more about Pilot II.
What is STARS? Who are the STARS Partners? What other STARS Pilot Projects are there? Find out more following the links or download our info sheet.
In this section, you will find documents with relevant regulatory information.
Some of the linked documents under 1-6 are in Spanish.
1. Regulatory Guidelines and Legislation
2. Quality Guidelines (Chemistry)
3. Quality Guidelines (Biologics)
4. Planning of Clinical Trials
5. Non-clinical Guidelines
6. Clinical Guidelines
In addition, our Comprehensive Inventory will help you to find support in regulatory affairs. Listed service providers include national competent authorities, public actors and private entities in your country.
Please also have a look at the slides from our Pilot I training course:
'The Winding Road from a Brilliant Idea to Drug Approval: An Online Course in Regulatory Science for Academic Researchers'
Here we provided an interactive PDF contact form so Spanish academia could let us know what kind of queries they had about regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products.
Our contact e-mail-address for Pilot II ist still available: firstname.lastname@example.org.
However, the pilot phase ended on 30 September 2021.
Please be aware that this pilot did not replace the Scientific Advice procedure. The objective was to facilitate informal exchange of information and guidance in the development process, complementing and reinforcing existing formal procedures.
In case you need comprehensive regulatory advice from AEMPS please write to: