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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

      Peter Terbeek

      • Director, Regulatory Affairs
      • 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
    Speaker(s)
      Greg John May

      Transitioning to ECTD, a Small Company Perspective

      Greg John May

      • Assistant Director, Regulatory Affairs
      • Nabriva Therapeutics, United States
      Representative Invited

      Managing a Global Portfolio, a Large Company Perspective

      Representative Invited

      • Amgen, Inc., United States
      Sandra A. Krogulski

      Supporting Multiple Specifications Simultaineously, a Vendor Perspective

      Sandra A. Krogulski

      • Regulatory Operations Submission Manager
      • Accenture, United States