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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Hosted Session: Case Study Spotlight hosted by Astrix: Evolving a Sponsor RIM Organization – Supporting Regulatory Excellence leveraging COEs and centralized capabilities

Session Chair(s)

  Sponsored Sessions

Sponsored Sessions

United States

As Sponsors continue to evolve and modernize their Regulatory Information Management (RIM) capabilities, it requires an evolution of the supporting business organization to exploit the value of modern RIM.

This session will explore the current state of RIM in the market, what business capabilities are required to support the modern RIM technology and broader Regulatory organizations’ use of it, as well as the business processes and governance required to “feed the beast.”

We will present different business models for RIM, and outline the pros and cons of each.

Featured Topics:

  • Understand how organizations are evolving and maturing in the strive for world-class RIM capabilities
  • What business capabilities are required to support the broader Regulatory organization?
  • What operating models make the most sense: COE, full centralized capability, or a mix?

Speaker(s)

Lindsay  Fitzgerald

Speakers

Lindsay Fitzgerald

Astrix, United States

Delivery Manager

Kristen  Sauter, MBA

Speakers

Kristen Sauter, MBA

Deloitte, United States

Life Science Consulting, Regulatory AI and Data Practice

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