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DIA 2018 Global Annual Meeting

Electronic Submissions Demystified

    Session Chair(s)
      Tessa  Brown, MPH, RN

      Tessa Brown, MPH, RN

      • Deputy Director, Div of Data Management Services & Solutions (FDA/OBI)
      • FDA, United States
    As of May 5, 2017, eCTD is required for NDA, BLA, and ANDA. As of May 5, 2018 Commercial INDs, and Master Files are required in eCTD format. Standardized study data is required. What are the typical issues FDA has seen with industry submitting in eCTD? How is industry doing in meeting the electronic submission standards? This session will provide an update on these topics and others focused on eCTD, submission metrics, and validation.
    Learning Objective : • Describe changes to registration and listing regulation • Define the National Drug Code (NDC) and its role in drug listing • Describe how to reserve an NDC • Describe how to certify a drug listing file
      Jonathan  Resnick

      FDA Perspective

      Jonathan Resnick

      • Project Management Officer, OBI, OSP, CDER
      • FDA, United States
      Sandra A. Krogulski, MA

      Submission Lifecycle Maintenance: Managing the Chaos

      Sandra A. Krogulski, MA

      • Regulatory Operations Submission Manager
      • Accenture, United States
      Julian  Chun, PharmD, MBA

      Are You Prepared for the Change? New and Updated Requirements in Drug Registration and Listing

      Julian Chun, PharmD, MBA

      • Pharmacist, OPRO, OC, CDER
      • FDA, United States