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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 2: Driving Process Optimization with Unified RIM

Session Chair(s)

Brooke  Casselberry, MS, RAC

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


Christina  Kim


Christina Kim

Veeva Systems, United States

Director, Vault RIM

Lisa N Pitt, PharmD


Lisa N Pitt, PharmD

Viela Bio, United States

Head of Regulatory Affairs

Ryan  Hernandez


Ryan Hernandez

Radius Health, United States

Director of Regulatory Operations

Michael  Sauter


Michael Sauter

United States

Senior Director, Global Regulatory Operations

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