Pilot Project II: A New Support Activity

With Pilot II we aim to improve the regulatory knowledge of academic health researchers and to enhance regulatory scientific advice.

From 1-30 September 2021, we are opening a one-stop-shop communication platform for Spanish academia exclusively.

This is a quick and informal way to get answers to your regulatory questions and help improve future scientific advice for European academic health researchers.

Pilot II will be performed by our Spanish consortium partner AEMPS (Spanish Agency of Medicines and Medical Devices). This service is free of charge.

Explanation Board

Pilot II Concept

The development of this novel support activity is based on comprehensive survey data that have been 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 has been 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 is 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 is free of charge.

To use this service, you can contact AEMPS by filling in the PDF contact form or by sending an e-mail. For further details proceed to the Communication Board.

info graphic illustration the role of STARS Pilot 2

Image 1. Summary of Pilot II © STARS | click image to expand

Pilot II Invitation

Download our invitation letter in English or in Spanish to learn more about your participation in Pilot II.

STARS Background

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.

Information Board

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'

Communication Board

Please use our CONTACT FORM (please download the form first, then complete and send it) to let us know what kind of query you have about regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products.

We will try to answer your questions as soon as possible. Before sending your enquiry, please check our Information Board for valuable and reliable information on regulatory matters.

You can also contact us vial e-mail: stars_pilot2@aemps.es

Please try to focus on a precise and short question to ensure a quick reply.

Please be aware that this pilot does not replace the Scientific Advice procedure. The objective is 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:

innov_spain@aemps.es

Help us get better at supporting you! 

Our survey tool allows you to give us individual feedback on which support actions would serve you best:

Open survey