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Session 6: Track 4: eCTD Publishing – eCTD Publishing Management and Efficiencies – Individual Submissions, Lifecycle, and Lifespan of Your eCTD.
Session Chair(s)
Daniel Orfe, MS
President and CEO, Regulatory eSubmissions, LLC, United States
Managing the publishing of an individual eCTD sequence is just the starting point. It is critical that lifecycle management be fully understood to provide for efficient and effective eCTD sequence production throughout the lifespan of a drug/biologic. Appropriate strategies and standards establishment can provide for a higher quality eCTD sequence deliverable as well and improved efficiency and turn-around time. This session will bring these important concepts to life over the course of these three presentations and Q&A.
Learning Objective : At the conclusion of this session, participants should be able to:
Speaker(s)
Submission Management and Archiving, Understanding Lifecycle Management
Sr Director, Regulatory Operations, Arena Pharmaceuticals, Inc., United States
Lifecycle Management: Surviving the Chaos
Senior Director, Head of Submission Sciences, Biogen, United States
eCTD Reference Citation Construct: What is it, Why it’s needed, Why an Industry Standard Would be Beneficial
President and CEO, Regulatory eSubmissions, LLC, United States
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