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Overview

Primer Registration: 9:30-10:30AM


Based upon the success of last years Primer, this activity is being offered again! All material has been reviewed and refreshed as needed to reflect industry and agency current state.
This activity is designed to meet the needs of individuals who are either new to biopharmaceutical-based document management, information management, and regulatory submission publishing for authorities, or already experienced in one area, looking to gain a broader understanding of the full spectrum of the regulatory submission, information, and document management arena.  Understanding the various steps throughout the life of document components from their conception, publishing into a submission, delivery to regulatory agencies, and ultimate company archival, will yield “ah-ha” moments for the attendees of this offering form all functions along the life-span of content.
Return to Regulatory Submissions, Information, and Document Management Forum.

Learning objectives

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

  • Describe the benefits of understanding the complete life phases of regulatory content and the impact that decisions in one place along the life path will have at other stages of the process
  • Identify key drivers within each of the life phases and potential pros and cons associated with solution choices
  • Recognize the needs of the other organizations involved within the life span of the regulatory content and fairly assess their concerns in process and procedure decision-making
  • Comprehend newly released regulations, guidance documents, and industry best practices and gain an awareness of their impact