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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 3 Track 2 - ERS Diverse Processes

Session Chair(s)

Thomas  Noto

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.


Ryan  Hernandez

A Race to Submit: An Overview of Submitting First-To-File ANDAs

Ryan Hernandez

Radius Health, United States

Director of Regulatory Operations

Mitchell  Seymour, PhD, RAC

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

Romuald  Braun, MS, MSc, RAC

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

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