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.
Karl-Heinz Loebel has spent the last 15 years in Regulatory Affairs, focusing on electronic submission, data management and systems implementation. He has been responsible for PharmaLex eCTD submissions in traditional ICH regions ever since and is now also coordinating the extension of the company’s publishing capabilities to the requirements of the regions that joint the eCTD community most recently, like China and EAEU.
Katharina has a master’s degree in Life Sciences (M. Sc. Life Science) and is a member of the Biopharma Excellence (BPE) Division within the PharmaLex group. She is a member of the EU Agent Team focusing on compilation and submission of MAAs (including pre-approval and post approval submissions to EMA). Her expertise is to aid in regulatory strategy and submissions for European and US approval pathways.