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Overview

Primer* Registration: 8:30-10:30AM


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 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 “aha” moments for the attendees of this offering from all functions along the lifespan of content.
At the conclusion of each section the attendees will be provided a list of the sessions at the forum, which can provide additional depth for that specific topic. Relevant DIA Communities will be identified at the conclusion of each session of the offering.
 
*Primer is not included in the forum registration and requires a separate fee.

Who should attend?

This offering is geared for professionals with 2-5 years experience within the field of electronic data management, regulatory information management, and/or electronic regulatory submissions.

Learning objectives

At the conclusion of the core curriculum, 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 the newly released regulations, guidelines, and industry best practices, and gain an awareness of their impact