Knowing where we are going: Interoperability, eCTD, and Regulatory Information Standards

September 9, 2015 10:00–11:00 Eastern Time (US & Canada)

The increasing importance of In-Licensing plus Merger & Acquisitions plus the need for automation efficiencies is driving a need for interoperable Regulatory Information Management (RIM) systems. This presentation will lay out the importance of interoperable RIM systems, focusing on eCTD submissions. Then it will consider some gaps and impacts of current e-Submission standards needed for interoperable systems.

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