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Overview

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


Whether you’ve submitted 100 initial filings, or are preparing for your first one, 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 submission and make you better prepared for the rapid responses during agency information requests. This short course will walk through the important regulatory and clinical guidance documents, connecting them specifically to submission needs. It will break down specific requirements by Module, including specific points on SPL creation and data packages, while noting best practices to avoid the dreaded RTF.

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

Learning objectives

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

  • Understand the ongoing international standardization work on IDMP and global regulatory landscape and adoption
  • Recognize the main features of the five IDMP standards and corresponding technical specifications
  • Prepare all relevant stakeholders for the implementation of the new IDMP standards with respect to their business requirements and data management activities (e.g., RIM, MDM)