IRISS-Forum Introduction

Implementation of Regulatory Information Submission Standards (IRISS) (pronounced ‘Iris’ – the flower) is conceptualized to be a global, open, multidisciplinary, non-profit organization dedicated to the implementation and widespread, successful adoption of electronic regulatory submission standards around the world.

IRISS aims to accelerate the adoption through creation of a diverse and dynamic stakeholder environment led and managed by experts in their field, without bias or commercial gain. IRISS will create a forum that is inclusive of life sciences companies of all sizes, industry service providers, health authorities, and technology development companies. The purpose is to collaborate, learn and share experiences and knowledge regarding practical global and regional application of electronic submission standards and processes. The scope is inclusive of clinical trial and marketing applications around the globe, including regional aspects and administrative processes. The current ICH eCTD specification, and its evolution, is the cornerstone of this effort. Other electronic regulatory submissions specifications, guidance, and standards, such as CDISC, HL7 SPL, PIM and NeeS, are also in scope.