IRIS, new online platform for scientific advice
13-10-2020 / Daniela van 't Ent - Ifrim / Branche
Starting with 19th of October 2020, Marketing Authorization Holders of human and veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform in order to request scientific advice regarding the study design.
The following type information may be requested via IRIS:
- human medicines:
- Initial and Follow-up Scientific Advice;
- Initial and Follow-up Protocol Assistance;
- Initial and Follow-up Qualification Procedure;
- veterinary medicines:
- Initial and Follow-up Scientific Advice.
Link to IRIS can be found here.
Guidance on how to register and use IRIS can be found here.
Online training: How to submit initial and follow-up scientific advice application (human) using IRIS (13/10/2020).
Online training: How to submit initial and follow-up scientific advice application (veterinary) using IRIS (14/10/2020).