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Session 6, Track A: Advancing Digital Submissions: Transforming Documents into Data in Regulatory Affairs
Session Chair(s)
Yatika Kohli, PhD, MBA
Chief Compliance and Strategy Officer
NoNO Inc, Canada
This session explores the shift from traditional document-based submissions to data-driven and content-based approaches in regulatory affairs. Attendees will gain insights into preparedness and collaboration of industry and regulators across domains to transition to data and content-based exchanges that are seamless, secure and efficient. Presentations will cover content standardization, the modernization of the CMC data lifecycle with Fast Healthcare Interoperability Resources (FHIR)- a Health Level Seven International (HL7®) standards and the vision of building a shared semantic layer for exchanging clinical, manufacturing and regulatory information.
- Enabling Digital Filings: Moving from Documents to Data
Todd Georgieff, RWS - Digital Submissions: Path to Real-time Regulatory Workflows and Personalization
Craig Anderson, Pfizer, Canada - Bridging Worlds: Aligning Clinical, Regulatory, and Manufacturing Data
Heiko Waldmuller, ACCURIDs
Learning Objective :
At the conclusion of this session, participants should be able to:
- To provide an overview of industry and regulatory efforts to move from document-based to data and content-based submissions
- To describe the problem statement and opportunity that content management, content governance and digital
- To describe how structured and semantically linked data can unlock automation
Speaker(s)
Enabling Digital Filings: Moving from Documents to Data
Todd Georgieff, MBA, RPh
RWS, Canada
Fonto IAP lead
Digital Submissions: Path to Real-time Regulatory Workflows and Personalization
Craig Anderson
Pfizer Inc , Canada
Director, Data Standards & Continuous Improvement
Bridging Worlds: Aligning Clinical, Regulatory, and Manufacturing Data
Heiko Waldmueller, DrMed, MD
ACCURIDS GmbH, Canada
Senior Consultant: Pharma & Digital Health Solutions
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