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Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
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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