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Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations, Lexicon Pharmaceuticals, United States
Learning Objective : -Overview of an original ANDA submission. -Distinguishing legal factors that make an ANDA first-to-file. -Identifying critical publishing standards to avoid receiving an RTR. -Identifying key miles stones when developing a project plan.
Speaker(s)
Ryan Hernandez
Director of Regulatory Operations, Radius Health, United States
A Race to Submit: An Overview of Submitting First-To-File ANDAs
Mitchell Seymour, PHD, RAC
Principal/Founder; Lead, Regulatory Operations, Biohaven Pharmaceuticals, United States
FDA eSubmissions for Non-Commercial Research INDs – Tools, Problems, and Promise to Reduce the Paper Burden
Romuald Braun, MS, MSC, RAC
Managing Director, Uanotau Gmbh, Switzerland
Integral Submission Lifecycle - A Holistic Approach to Comprehensively Manage CMC Submission Documents and Processes Globally