Implementation of Regulatory Information Submission Standards (IRISS) is a global, non-profit professional organization dedicated to the implementation and widespread, successful adoption of electronic regulatory submission standards around the world. Active Topic Groups Include: Global Submissions Operations (GSO), AdPromo, CMC, IDMP IRISS aims to accelerate the adoption of electronic submission standards by making experience and expertise available to its membership through an operating model commonly known as crowdsourcing.
- Issues are broadcast to a wide community of domain experts and novice users
- Solutions and points to consider are offered through the membership community
- Novice users benefit from lessons of experienced early adopters
- Development organizations can benefit from listening to trends and issues in the community of users
- All member organizations benefit from a wider pool of talent than exists within their own organization
IRISS-Forum operates as an independent, neutral body free from regional or vendor solution bias where experts and novices gather, regardless of organizational affiliation to discuss, clarify and address pressing issues relevant to the successful adoption of a paperless regulatory environment for submissions. You’ll find additional information on IRISS activities, membership, and sponsor opportunities throughout the IRISS Forum website.
Specialties
eCTD, IDMP, Regulatory Submissions, Regulatory Operations, CMC, Labeling/AdPromo