Training on Scientific Advice for academic medicine developers

Within the European Rare Diseases Research Alliance, EATRIS and the European Medicines Agency (EMA) have partnered to create this tutorial on the Scientific Advice (SA) process. This video is designed for academic medicine developers who want to ensure their research is aligned with regulatory expectations and who seek guidance on generating robust evidence to support medicine development. In this tutorial, we will explain what Scientific Advice is, highlight its benefits, and guide you through the steps of the process — from registering in IRIS, EMA’s secure online submission portal, to preparing your briefing document and formulating clear regulatory questions. You will also learn how to structure effective Scientific Advice questions, how EMA experts evaluate them, and how to use the feedback to shape your development strategy. Finally, we introduce other EMA interaction pathways, including Protocol Assistance, Innovation Task Force (ITF), SME and Academia support offices, and more. Whether you are working on an innovative treatment, repurposing an existing medicine, or developing advanced therapies, this tutorial will help you navigate the EMA Scientific Advice pathway with clarity and confidence.
Timecode
00:00 - Introduction
01:42 - What is Scientific Advice
10:54 - Fee Waiver for Scientific Advice
14:05 - Online submission portal IRIS
19:19 - Preparatory meeting
21:10 - How to write your briefing document
33:48 - What kind of Scientific Advice questions can I ask?
37:24 - Applicant's position
39:33 - How to formulate your questions
45:34 - Scientific guidelines and EPARs as useful resources
47:14 - Submitting your application through IRIS
47:56 - What happens after submitting your SA request
51:07 - SA for veterinary products
55:34 - Protocol assistance
56:42 - Qualifications of Novel Methodologies
58:43 - Emergency Task Force (ETF)
1:03:40 - ACT EU pilots (Pre-CTA SA and SA/CTCG)
1:05:55 - Joint Scientific Consultations (HTA)
1:09:08 - National Scientific Advice
1:11:13 - Academia Briefing Meetings
1:13:22 - SME office
1:15:40 - Innovation Task Force (ITF)
1:18:19 - ACT-EU Helpdesk
1:19:08 - Key messages

Useful links:
IRIS guidance: https://www.ema.europa.eu/en/document...

Scientific guidelines: https://www.ema.europa.eu/en/human-re...

Medicine Finder: https://www.ema.europa.eu/en/medicines

Qualifications of Novel Methodologies:    • EMA's Qualification of Novel Methodologies...  

Emergency Task Force: https://www.ema.europa.eu/en/committe...

Joint Scientific Consultations: https://health.ec.europa.eu/health-te...

EMA Academia webpage: https://www.ema.europa.eu/en/partners...

SME office: https://www.ema.europa.eu/en/about-us...

ACT EU Support for non-commercial sponsors: https://accelerating-clinical-trials....

This video has been developed through funding from the European Rare Diseases Research Alliance (ERDERA). ERDERA is an initiative that has received funding from the European Union’s Horizon Europe Research & Innovation programme under grant agreement No. 101156595.