Annual Event Joins Electronic Data Management and Electronic Regulatory Submissions

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Today’s entry was provided by Emily Onkka, Director of Project Management and Regulatory Operations at GlobalSubmit and new regular contributor to Based in San Diego, CA, she will be leading GlobalSubmit’s professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations at Ardea Biosciences, Inc.

This year, DIA combined two conferences joining the electronic data management (EDM) and electronic regulatory submission (ERS)/eCTD into one event. The conference provided three tracks split into content generation, content management, and electronic submission focus areas. There were also several collaborative sessions that allowed meeting attendees to share ideas and best practices for managing the content continuum from authoring to submission delivery and maintenance. The meeting was well attended both by FDA and industry alike; allowing sponsors access to first-hand updates from the FDA speakers on electronic submission initiatives.

FDA speakers communicated that the Agency will likely begin accepting eCTD Version 3.2.2 in early 2014. Sponsors will not be required to upgrade to eCTD Version 3.2.2; however, once a sponsor starts submitting in eCTD Version 3.2.2, they cannot revert to the old format. With regard to RPS, although eCTD Version 4 is still in testing at ICH, the FDA continues to convey their commitment to implementing the standard and begin accepting it potentially as early as 2015. All of the new functionality in eCTD Version 3.2.2 will be part of eCTD Version 4. Therefore, although the two new versions seem to have relatively close implementation dates, the effort sponsors will go through to update internal business processes that will support the implementation of eCTD Version 3.2.2 will not be lost when implementing eCTD Version 4 (RPS) a year or so later.

As in years past, the conference continues to provide practical and relevant information to attendees. One final note, be sure to also check the FDA Forms Page for new versions of forms 1571 and 356h that were released on October 1, 2012.

Author: Emily Onkka

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