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Session 4 Track 2: Use of Regulatory Data
Session Chair(s)
Steven Clark, MSc
Director
Amgen, United Kingdom
In the past, regulatory processes were centered on document management, publishing, and tracking sheets. With continued technology advances, organizations can now “go digital” in their operations by leveraging the data-handling capabilities in their RIM systems to improve everything from health authority interactions to submission management. This session will provide three case studies to illustrate the efficiency benefits of linking RIM with submission documents. Case studies will include managing health authority correspondence and commitments, submission planning, and product registration management.
Learning Objective : Incorporate a quantitative approach to measuring the status and performance of regulatory processes. Link regulatory documents and data in ways that enable greater process automation. Assess the impact of change events by tracing relationships between registrations, commitments, and submissions
Speaker(s)
Connecting Submission Documents and Regulatory Data to Bring True Efficiency to Regulatory Processes
Jim Reilly
Veeva Systems, United States
VP, Vault R&D and Quality
Unifying RIM: End-to-End Submission Development
Sandra Herder
The Medicines Company, United States
Director Regulatory Operations
Dear Excel: I Met Someone Better to Manage My Health Authority Interactions and Correspondences - We’re Breaking Up! Best of Luck, Reg Ops
Ronald Hernando, MBA
Veeva Systems, United States
Sr. Consultant, Vault RIM Business Process Consulting
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