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Session 3 Track 2 - ERS Diverse Processes
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations, Lexicon Pharmaceuticals, United States
This session will focus on a broad spectrum of environments where eCTD is being implemented. First, we will explore the challenges of submitting eCTDs in the high-pressure world of generic drugs. Second, we will identify barriers and potential tools to accelerate adoption of eCTD in academia. Finally, we will discuss processes to increase the performance of CMC-driven variations through automated content creation processes.
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
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