14th DIA Conference on European Electronic Document Management

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.