eCTD Glossary

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I:
ICH
ICH M2 EWG
IRISS
 
IRISS
Implementation of Regulatory Information Submission Standards. Citation from IRISS website: "The mission of IRISS is to enable successful implementation and practical usage of a 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 specification is the cornerstone of this effort, but other electronic regulatory submissions standards, such as CDISC and HL7 standards are also in scope."

The IRISS Forum is build of several topic groups responsible for discussing aspects related to CMC, lifecycle, metadata, interoperability.
Siehe auch:
ETICS
ETIG



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