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Session 10 Track 1: “Good RIM” – Key Considerations on Establishing Comprehensive Data Readiness, Governance & Quality Management
Session Chair(s)
Kristen Sauter, MBA
Life Science Consulting, Regulatory AI and Data Practice
Deloitte, United States
Cary Smithson, MBA
Managing Partner and Owner
LeapAhead Solutions, Inc., United States
Regulatory Information Management System (RIMS) implementations are hard. However, RIM Systems are a critical component for Regulatory organizations to manage global regulatory registrations and submission information. With the increasing complexity of the data that is managed and shared, it is important to take a comprehensive approach to ensure data readiness, migration and establishing a data governance and data quality framework. This session will include going one-step beyond RIMS implementation and will outline novel approaches and methodologies for data cross-functional data unification, especially from supply chain, R&D, and regulatory affairs, without direct system linkages.
Learning Objective : At the conclusion of this session, participants should be able to:
- Review key elements of establishing a Data Governance Program
- Learn approaches to data unification and sustaining data unification without system integration
- Understand the impact of implementing RIMS with poor data quality
Speaker(s)
Implementing RIM Governance
Olivier Hustin
Takeda Pharmaceuticals, United States
Director, Regulatory Operations - Governance
Novel Concepts to unify Cross Functional Data Silos
Stephen Blanchard, MS
Johnson & Johnson Consumer Health, United Kingdom
IDMP Programme Lead
Is Your Data Ready for RIMS?
Samuel Thompson
N/A, United States
Managing Consultant
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