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Session 7 Track 1 - Best Practices for eCTD Submission Development: Upstream and Downstream Activities that Impact the Submission Date
Session Chair(s)
Emily Onkka
Senior Director, Regulatory Affairs
Pfenex, Inc., United States
Learning Objective : Prepare for a large eCTD submission at your company. Discuss how to mitigate issues with thorough submission planning. Describe executing and adjusting the submission plan for a successful submission.
Speaker(s)
Case Study: Preparing Your Largest eCTD NDA Submission
Vishu Manegari, MBA, MS
Daiichi Sankyo, United States
Executive Director
The Big Picture of eCTD Document Navigation: How Process, Perspective and People Make Measurable Impacts on Regulatory Subm
Craig Gassman, MS
Karyopharm Therapeutics, Inc., United States
Manager, Regulatory Operations
Presentation Title TBA
Michelle Petty
Biogen Idec, United States
Associate Director, Regulatory Operations
The eCTD Red Zone: Managing Critical Path Activities to Accelerate the Submission Date
Emily Onkka
Pfenex, Inc., United States
Senior Director, Regulatory Affairs
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