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Session 7 Track 4: Keeping up with Trends in eCTD: Submitting in US Module 1 Specification
Session Chair(s)
Peter Terbeek, MBA
Senior Director, Regulatory Operations
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)
Transitioning to ECTD, a Small Company Perspective
Greg John May
Nabriva Therapeutics, United States
Assistant Director, Regulatory Affairs
Managing a Global Portfolio, a Large Company Perspective
Jennifer Moore
Amgen, Inc., United States
Manager, GRAAS Ops Publishing
Supporting Multiple Specifications Simultaneously, a Vendor Perspective
Sandra Krogulski, MA
Bristol-Myers Squibb Company, United States
Director, GRSO Innovation and Business Operations Lead
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