This episode offers a concise guide to IRIS at the EMA for managing post-authorization procedures. It outlines key changes, timelines, and required actions to ensure a smooth transition.
Highlights:
SIAMED Replacement: By December 2024, IRIS will fully replace SIAMED in managing procedures for centrally and nationally authorized products (CAPs and NAPs).
Transition Timeline: Submissions before the cutoff date stay in SIAMED; post-transition, they move to IRIS.
Submission Process: Submission methods remain unchanged; IRIS focuses on post-submission management.
User Roles: Assign roles like Manager or Contributor in IRIS for access and management. Individual email addresses are mandatory—no generic mailboxes.
QPPVs and Collaboration: QPPVs are encouraged to register in IRIS to support safety referrals. IRIS replaces Eudralink for secure document sharing and procedure management.
Actions for MAHs: Ensure personnel have EMA accounts and IRIS roles. Replace generic mailboxes with personal email addresses. Attend training webinars and review guides to master IRIS.
The IRIS transition improves transparency, streamlines communication, and efficiently manages post-authorization procedures. This episode prepares MAHs to adapt to and thrive in the updated regulatory environment.