Notes from the DIA Doc Management Meeting

DIA held the 22nd annual Doc Management meeting in Philadelphia the week of February 9th.  Attendance at the conference was good.  I talked with colleagues from many different sponsor companies and vendors – both folks I already knew and new acquaintances.  I was interested and encouraged to hear that most are seeing progress in eCTD adoption, despite the recent economic downturn.

 On “Regulatory Day”, we heard from a variety of FDA speakers on the topic of eCTD (and RPS), including:

  • Gary Gensinger, Deputy Director of CDER’s office of Business Support, gave a variety of updates on eCTD-related initiatives and provided various metrics – including the latest count of eCTD sequences received as of February 9th53,970
  • Mary Padgett, Consumer Safety Officer from CDER, spoke about RPS
  • Olivia Easley, a Medical Officer from Division of Reproductive and Urologic Products, presented the Clinical Reviewer perspective for eCTD
  • Arthur Shaw, Research Chemist and DMF Expert, gave a DMF Expert Reviewer perspective
  • David Roeder, Associate Director for Reg Affairs in the Office of Antimicrobial Products, gave a PM perspective
  • Virginia Ventura, Team Leader of the Electronic Submission Support team in CDER’s Office of Business Process Support, provided practical guidance on eCTD issues and best practices

Some key points about eCTD that I heard from the FDA presentations included:

  • FDA is not looking to punish sponsors for every error in an eCTD, and they will overlook many minor errors (both technical and business) that don’t cause them significant problems. If you forget a form, they will just ask you for it. But if you “forget” all of M5 and then take four weeks to supply it – as Gary says, that needs to be on your clock, not his!
  • However, high priority errors are very likely to cause your submission to be rejected, or as they more diplomatically phrase it, to be considered “not received”. (My next blog entry will examine this issue in more detail).
  • FDA will not correct your submission for you. They don’t have clerical staff to do this nor do they always know the sponsor’s intent.
  • The submission gateway is increasingly popular, with 185 companies now using it (the majority for safety reports). However, several sponsor organizations joined the FDA in singing its praises, as it can result in submissions being available to the reviewers in as little as 15 minutes after release to the gateway.
  • For a major submission, you (the sponsor) may want to consider offering reviewers a “tour” of your eCTD a week or so after submission

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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