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Session 1 Track 1 - Leveraging the eCTD for Global Efficiency
Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
This session will share best practices in preparing eCTD (and CTD) submissions for multiple regions. For competitive advantage, it is critical for global companies to maximize registrations across multiple regions. The eCTD format was intended for efficient reuse and this session will explore the realities involved. Topics include decisions regarding simultaneous submissions, readiness and evaluating regional publishing support. It is also important to plan for life-cycle maintenance in a global context and how to handle non-eCTD submission in some regions.
Speaker(s)
Repurposing eCTD for Multiple Regions
Robert Connelly, MBA
Incyte, United States
Senior Director, Global Regulatory Operations
An Affiliate Submission Perspective from EU
John-Paul Smith
Astellas Global Regulatory Affairs Europe, Netherlands
Associate Director Regulatory Operations
Beyond eCTD Consolidation Effort and Resubmission (CTD)
Meredith K Sewell
Sarepta Therapeutics, United States
Vice President, Regulatory Operations
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