The mission of IRISS is to enable successful implementation and practical usage of paperless regulatory submissions environment which supports current regulatory processes and enables efficient and effective assembly, review, and maintenance of required regulatory information in support of clinical trial applications and marketing applications around the globe. The current ICH eCTD specifications is the cornerstone of this effort but other electronic regulatory submissions standards, such as CDISC and HL7 standards are also in scope.
Electronic submissions standards are created and developed by a variety of different organizations with different needs and objectives.
IRISS (Implementation of Regulatory Information Submission Standards) Forum was created to address the need for a single central forum for open, and broad stakeholder discussion of evolving standards, user requirements and practical, global implementation issues of these standards for the mutual benefit of both industry, government agencies and ultimately, public health.
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Subscriptions are free for government agency employees.