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eINFRASTRUCTURE FOR TESTING, INTEGRATION AND CONFIGURATION OF SOFTWARE (ETICS)
Session Chair(s)
Harv W Martens
Technical Expert for JPMA on ICH M2 and M8 Expert Working Groups
United States
After 11 years in the public domain, the eCTD standard: • Is more stable • Is better understood by industry, regulators and vendors • Is more widely implemented in ICH and non-ICH countries • Has mature tools available However, anyone who has tried to migrate submissions from one eCTD publishing tool to another, or has submitted eCTDs to multiple regulatory agencies, will likely agree that issues of compliance and interoperability between tools remain. The ETICS study, now in its third iteration and a special project of the IRISS Forum, was designed to explore these issues and to guide vendors toward a better understanding of ICH and agency requirements as well as demonstrate how their tools interoperate with competitors’ tools. This session will review the findings of ETICS III in the US, EU and Canada.
Speaker(s)
Panel
Bryan Ennis
Veeva Systems, United States
Director, R&D Customer Success
Panel
Ted Hanebach, RAC
Mapi Group SRS, Canada
Director of Regulatory Operations
Panel
John-Paul Smith
Astellas Global Regulatory Affairs Europe, Netherlands
Associate Director Regulatory Operations
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