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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
Executive Director, Regulatory Data and Document Operations, Astellas Pharmaceuticals, 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
Assistant Director, Regulatory Affairs, Nabriva Therapeutics, United States
Transitioning to ECTD, a Small Company Perspective
Jennifer Moore
Manager, GRAAS Ops Publishing, Amgen, Inc., United States
Managing a Global Portfolio, a Large Company Perspective
Sandra Krogulski, MA
Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Supporting Multiple Specifications Simultaneously, a Vendor Perspective