Hello everyone,

I have a few questions regarding the notifications that a Qualified Person for Pharmacovigilance (QPPV) receives through the IRIS system:

  1. What types of notifications are sent specifically to the QPPV?
  2. Are these same notifications also received by other users with the "Industry Manager" role?
  3. From where does the EMA source the QPPV details (e.g., EVMPD)?
  4. Are there any notifications that are exclusively sent to the QPPV and not to any other roles?

Understanding these details will help us establish a clear process for which department should act on each type of notification.

Thank you in advance for your assistance!

Best regards,
Vasavi Kalyani