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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
Senior Director, Head, Global RIM, Analytics & Digital Innovation
Takeda Pharmaceuticals, United States
Cary Smithson, MBA
Managing Partner
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
NNIT, United States
Managing Consultant