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Session 8 Track 2: Driving Process Optimization with Unified RIM
Session Chair(s)
Brooke Casselberry, MS, RAC
Vice President, Advisory and Delivery
Epista Life Sciences, United States
In this panel session, three regulatory leaders from Viela Bio, Radius Health, and Alexion Pharmaceuticals will join the director of RIM strategy at Veeva to explore how modern RIM technology can streamline regulatory processes like registration tracking, submission management, health authority interactions, submission document authoring, and submission archiving and viewing. In addition, they will talk about the planning that happens in parallel to ensure system adoption following go-live, including change management, training, and procedural document development and updating. Lastly, they will discuss how a modern RIM platform can flex and support regulatory operations as companies enter new markets around the globe.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Recognize how a modern RIM platform can enable regulatory process optimization and drive other efficiency gains
- Identify several ways to improve RIM system adoption before, during, and after launch
- Assess how RIM technology can support growing regulatory efforts as your company expands into new markets and new areas of medicine
Speaker(s)
Speaker
Christina Kim
Veeva Systems, United States
Director, Vault RIM
Speaker
Lisa N Pitt, PharmD
Viela Bio, United States
Head of Regulatory Affairs
Speaker
Ryan Hernandez
Radius Health, United States
Director of Regulatory Operations
Speaker
Michael Sauter
United States
Senior Director, Global Regulatory Operations
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