UNICOM Cooperates with “Implementation of Regulatory Information Submission Standards” (IRISS) Forum
On 12 March 2020, Prof. Dr. Karl A. Stroetmann, scientific coordinator of UNICOM, was invited to present at the IRISS IDMP Topic Group’s monthly (online) meeting to spread the word about UNICOM’s vision, mission, and objectives, as well as to share initial implementation planning and to explore cooperation options. A global audience of around 60 experts attended.
IRISS stands for Implementation of Regulatory Information Submission Standards forum, that has an IDMP Topic Group focusing on enabling successful implementation and practical usage of a paperless regulatory submissions environment. It supports current regulatory processes around medicinal products. Apart from that it enables efficient and effective assembly, review, and maintenance of required regulatory information in support of clinical trial applications. Marketing applications for new medicines around the globe are also covered by IRISS.
Members come from a wide range of organisations with different needs and objectives from both sides of the Atlantic involved in electronic submissions standards creation, development and implementation. They assemble monthly to update each other on the progression of IDMP implementation and related topics.
It turned out that by now UNICOM is already a widely known European initiative supporting faster implementation and diffusion of the IDMP suit of standards for univocal identification of medicinal products. Several presentations at this meeting referred to UNICOM, which underlines the prospective fruitfulness of the project and its already high visibility on both sides of the Atlantic. As the chair of the meeting formulated it, UNICOM has already become “a shot of steroids” for the process of implementation of IDMP across Europe.
Lively interest was invoked from the side of stakeholders participating in the teleconference, and the UNICOM consortium is looking forward to the agreed further cooperation with IRISS.