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Regulatory Submissions, Information, and Document Management Forum

Session 4 Track 2: Use of Regulatory Data

Session Chair(s)

Steven  Clark, MSc

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


Jim  Reilly

Connecting Submission Documents and Regulatory Data to Bring True Efficiency to Regulatory Processes

Jim Reilly

  • Vice President, R&D Strategy
  • Veeva Systems, United States
Sandra  Herder

Unifying RIM: End-to-End Submission Development

Sandra Herder

  • Director Regulatory Operations
  • The Medicines Company, United States
Ronald  Hernando, MBA

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

  • Sr. Consultant, Vault RIM Business Process Consulting
  • Veeva Systems, United States