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Session 4 Track 2: Connecting Regulatory, Clinical, and Quality Information
Session Chair(s)
Danielle Beaulieu, PhD
Senior Director, Global Regulatory Business Capabilities
Bristol-Myers Squibb, United States
Regulatory, clinical, and quality teams leverage hundreds of overlapping documents and data points, but this information often exists in disparate systems. This session will focus on strategies for connecting regulatory, clinical, and quality information to streamline complex processes. We’ll hear from two innovation biopharma companies, Vertex and Urogen, on how they faced with data model design and governance and what benefits they hope to achieve.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand methods and design principles for building a cross-functional data model
- Describe practical ways to connect data between regulatory, clinical, and quality processes and systems
- Recognize successful outcomes of connecting data
Speaker(s)
Regulatory, Quality and Clinical Data Connection Points: What Are the Possibilities and How Do We Prioritize?
Alison Marjanowski
Veeva, United States
Director, Vault RIM
Connecting Quality and Regulatory Information
Rebecca Smissen, MBA, MS
Vertex Pharmaceuticals, Inc, United States
Director, RIM Strategy
Connecting Clinical and Regulatory Information
Dominick Gagliostro, PMP
Urogen Pharma, United States
Sr. Director, Project Management and Regulatory Operations
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