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Session 8, Track 3: Implementing Innovation Successfully via Robust Data Standards
Session Chair(s)
Rita Algorri, PhD, MS
Senior Manager, Global Regulatory Affairs (CMC)
Amgen, United States
For organizations of all sizes, data is quickly becoming the most valuable and powerful asset. In this session, attendees will learn about the importance of driving data consistency and accessibility using different approaches, including implementation of data standards and centralized data accessibility solutions. The session will explore two distinct use cases on structuring CMC and labeling content with Health Level 7’s (HL7) Fast Healthcare Interoperability Resources (FHIR), as well as demonstrate the utility of a Data Marketplace to bolster data usability and visibility.
Learning Objective : - Describe how a data marketplace can work synergistically to support data standards implementation
- Recognize real-world implications and benefits of implementing a cohesive organizational data framework
- Evaluate the utility of interoperability and centralized data accessibility across domains (linking CMC, labeling, and clinical data to generate and expand insights)
Speaker(s)
FHIR and the Race to Reduce Time and Effort Needed to Achieve Global Regulatory Approvals
Sheetal Gaiki, MPharm
Johnson & Johnson Innovative Medicines, United States
Senior Principal Scientist II, Dossier Development & Operations
Driving Value with IDMP-coded Structured Labeling Content
Niklas Jaenich, PhD, RPh
Boehringer Ingelheim, Germany
Head of Global Labeling Operations and Digitization
How an Enterprise Data Marketplace can Improve Decision-making and Create Measurable Benefits for your Organization
Donna Yosua
Merck & Co., Inc, United States
Director, Master Data Management & Data Governance