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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 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

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?


Lindsey  Fitzgerald


Lindsey Fitzgerald

Astrix, United States

Senior Consultant

Kristen  Sauter, MBA


Kristen Sauter, MBA

Takeda Pharmaceuticals, United States

Senior Director, Head, Global RIM, Analytics & Digital Innovation

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