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Bethesda North Marriott Hotel and Conference Center

Feb 05, 2018 8:30 AM - Feb 05, 2018 12:00 PM

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

Course 2: Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)

Overview

Short Course Registration: 8:00AM-12:00PM

Whether you’ve submitted 100 initial filings, or are preparing for your first eCTD sequence, getting your team ready for that initial submission is always important. Dotting all the i’s and crossing all the t’s can lead to a successful eCTD sequence submission and make you better prepared for providing rapid responses during agency information requests. The course will walk through the important regulatory and clinical guidance documents, connecting them specifically to submission needs. This tutorial will focus on US applications. The Marketing applications break down will include specific requirements by Module, including specific points on SPL creation and data packages. The transition from paper to eCTD sequences for the upcoming IND/DMF eCTD format FDA mandate will be covered along with tips and tricks to ease this transition for your organization.

Return to Regulatory Submissions, Information, and Document Management Forum.

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Apply best practices for US eCTD Submissions
  • Recognize how clinical data packages impact the regulatory world
  • Implement best practices for managing an application’s lifecycle

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