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Overview

Primer Registration: 9:30-10:30AM *Primer requires an additional registration fee*

These talks are designed to meet the needs of individuals who are either new to biopharmaceutical-based regulated document management, information management, and regulatory submission publishing for authorities or already experienced in one area looking to gain a broader understanding. This Primer will present the full spectrum of the regulatory submission, information and document management arena. Understanding the various steps throughout the life of document components from their authoring, publishing to PDF, assembling into a submission, delivery to regulatory agencies, and ultimately company archival will yield “aha” moments for the attendees of this offering from all functions along the life-span of regulatory content. Ice breakers will motivate and the “Hands-On” exercises will provide the attendees the ability to apply material as the day progresses.

This Primer will educate you as well as prepare you to optimize your RSIDM experience. Hands on use of the DIAglobal app and roadmap to finding relevant sessions will be shared.

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 lifespan 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