We are updating our Privacy Policy and Terms and Conditions to help you clearly understand how your personal information is collected, stored and managed. Learn More
Menu Back toElectronic-Submissions-Demystified

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Electronic Submissions Demystified

    Session Chair(s)
      Tessa  Brown, MPH, RN

      Tessa Brown, MPH, RN

      • Deputy Director, Div of Data Management Services and Solutions, OBI, CDER
      • FDA, United States
    During this session, FDA and industry will provide a summary on electronic submissions. As of May 5, 2017 and May 5, 2018, eCTD is required for NDA, BLA, and ANDA and Commercial IND and DMF submissions, respectively. FDA will provide an update on submission metrics and industry will provide an overview of best practices for successful submission. Additionally, FDA will provide an update on requirements for drug registration and listing, which are intended to improve FDA and industry processes.
    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, DRLS, OPRO, OC, CDER
      • FDA, United States