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Session 7 Track 3: Rethinking Documents: the Digital Content Revolution
Session Chair(s)
Cindy Chiu
Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States
This session will challenge the audience to think about the evolution from paper documents to digital content. We will share a use case for an EDM implementation at National Institute of Allergy and Infectious Diseases (NIAID), then transition to discussing the future of Regulated Transactions. Finally, we will dive into structured content authoring and management and share examples from pharma and other industries.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the increased urgency surrounding compliant digital transformation across life science organizations amidst the COVID-19 pandemic
- Discuss how technology can become a true enabler to automate, manage and trace the information we create to bring safe medication to our patients faster
- Understand structured content and recognize strategies for content reuse
Speaker(s)
Accelerating Compliant Digital Transformation and Optimizing EDM Workflows
Matthew Eisenberg
NIH, United States
Chief, Business Process and Information Management Branch
Accelerating Compliant Digital Transformation and Optimizing EDM Workflows
Kimberly Sivananthan, MPH
NIAID, United States
Quality Management Analyst
Operationalizing Regulatory Content: A Future of Regulated Transactions
Karen Jones
Accumulus Synergy , United States
Head of Regulatory Innovation
The Future of Documents: Structured Content and Integrated Data
Jan Benedictus, MS, MSc
RWS, Netherlands
Managing Director, Fonto
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