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.
How to apply and benefit from Scientific Advice
The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575.
The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.