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Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 4: Keeping up with Trends in eCTD: Submitting in US Module 1 Specification

    Session Chair(s)
      Peter  Terbeek, MBA

      Peter Terbeek, MBA

      • Senior Director, Publishing and Submission
      • Astellas, United States
    This session will explore the good, the bad and the ugly of transitioning to the new US Module 1 Specification. We will examine considerations and obstacles for converting and hear from a vendor on how to support a mixed portfolio. We will cover software and validation considerations, training to understand the regulatory changes, and US M1 metadata and new document fields. This session will encourage your participation by asking questions and polling your experiences.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Understand the benefits and differences in the new US module 1 specifications
    • Identify strategies to implement the new US module 1 specification within their organization
      Greg John May

      Transitioning to ECTD, a Small Company Perspective

      Greg John May

      • Assistant Director, Regulatory Affairs
      • Nabriva Therapeutics, United States
      Jennifer  Moore

      Managing a Global Portfolio, a Large Company Perspective

      Jennifer Moore

      • Manager, GRAAS Ops Publishing
      • Amgen, Inc., United States
      Sandra A. Krogulski, MA

      Supporting Multiple Specifications Simultaneously, a Vendor Perspective

      Sandra A. Krogulski, MA

      • Regulatory Operations Submission Manager
      • Accenture, United States