戻る Agenda
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)
A Race to Submit: An Overview of Submitting First-To-File ANDAs
Ryan Hernandez
Radius Health, United States
Director of Regulatory Operations
FDA eSubmissions for Non-Commercial Research INDs – Tools, Problems, and Promise to Reduce the Paper Burden
Mitchell Seymour, PHD, RAC
Biohaven Pharmaceuticals, United States
Principal/Founder; Lead, Regulatory Operations
Integral Submission Lifecycle - A Holistic Approach to Comprehensively Manage CMC Submission Documents and Processes Globally
Romuald Braun, MS, MSC, RAC
Uanotau Gmbh, Switzerland
Managing Director