The European Medicines Agency (EMA) has created the IRIS platform to facilitate the exchange of regulatory and scientific information with industry for some regulatory procedures out of scope of the usual eCTD format regulatory submissions, used for obtaining and maintaining marketing authorisations. IRIS is more than a simple submission portal but provides an online workspace to the applicants where application key particulars need to be assembled using structured data based on controlled terminology. Before preparing any submission in IRIS, applicants must overcome several hurdles including user and company registration, role management, and ensuring the availability of the controlled terminology for their products and intended tasks. Potential pitfalls are abundant on the applicant’s path from login to successful submission. In this online seminar, you will learn what they are and how to circumnavigate them.
The speakers Karl-Heinz Loebel (PharmaLex) and Katharina Weißenborn (Biopharma Excellence by PharmaLex) will give you a technical overview on IRIS platform and the submission requirements for scientific advice requests, orphan designation application and the recently introduced i-SPOC applications.
Key learnings:
- Know the important requirements for submissions via the IRIS platform
- Become familiar with the role management and registration for IRIS accounts
- Understand the submission requirements before requesting scientific advice and orphan designation
- Find out if i-SPOC is relevant for you as Marketing Authorisation Holder
