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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
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)
Speakers
Lindsey Fitzgerald
Astrix, United States
Senior Consultant
Speakers
Kristen Sauter, MBA
Takeda Pharmaceuticals, United States
Senior Director, Head, Global RIM, Analytics & Digital Innovation
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