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Session 1 Track 2: Preparing for the New Module 1 (3.3 Format)
Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
Learning Objective : Creating an eCTD Application in the new US module 1, 3.3. Understanding how to input contact information in the new Module 1 Understanding how to cross-reference other applications new Module 1 Reviewing new file formats for promotional material.
Speaker(s)
Using the New FDA Module
Robert Connelly, MBA
Incyte, United States
Senior Director, Global Regulatory Operations
Lessons Learned Creating Sequences in the New FDA Module 1
Michael Frantz
Pharmaceutical eConsulting Inc., United States
Sr. Principal Consultant
FDA's Module 1 Update: From Ideas to Implementation
Jared Lantzy, PMP
Novavax, Inc., United States
Executive Director, Global Regulatory Operations