From 19 October 2020, scientific advice applicants will be required to use the IRIS Platform for Regulatory and Scientific Information Management to manage the scientific advice processes with EMA. To start using the platform, it is extremely important that scientific advice applicants meet all the requirements described in the IRIS guide to registration (Quick interactive guide to IRIS registration process).
EMA will hold the following online training sessions to guide and support you in the transition to IRIS:
- IRIS registration and request of RPI
- How to submit an Initial and Follow-up Scientific Advice (human) application in IRIS
- How to submit an Initial Scientific Advice and Follow-up (veterinary) application in IRIS
More information about training sessions available on the EMA corporate website. Links to the broadcast will be published closer to the training dates and EMA will publish the training video recordings.
IRIS will provide a single space for applicants to submit and manage all information related to their scientific advice applications, and will allow them to check the status of their applications from any device as well as to receive automatic status-update notifications. This is expected to reduce the time needed to prepare and submit applications and ensure better data quality through integration with other EMA systems.