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Session 8, Track 3: How to Be Data-Centric: A Practical Approach for Data-Driven Regulatory Authoring and Exchange
Session Chair(s)
Rita Algorri, PhD, MS
Senior Manager, Global Regulatory Affairs (CMC)
Amgen, United States
Biopharmaceutical organizations generate and consume large volumes of data throughout the drug development lifecycle. However, this data is often siloed across different systems, unstructured, and unstandardized, limiting its usability. In this session, attendees will learn how to modernize key regulatory business processes by enabling data centricity, interoperability, and data standardization. The session will include discussion of real-world examples of data marketplace implementation, FHIR-based data exchange, and an IDMP-coded structured labeling use case.
Learning Objective : - Understand how a cohesive data management strategy can drive modernization of key business activities
- 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
Speaker(s)
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
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