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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 3: Rethinking Documents: the Digital Content Revolution

Session Chair(s)

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations, 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)

Matthew  Eisenberg

Matthew Eisenberg

Chief, Business Process and Information Management Branch, NIH, United States

Accelerating Compliant Digital Transformation and Optimizing EDM Workflows

Kimberly  Sivananthan, MPH

Kimberly Sivananthan, MPH

Quality Management Analyst, NIAID, United States

Accelerating Compliant Digital Transformation and Optimizing EDM Workflows

Karen  Jones

Karen Jones

Head of Regulatory Innovation, Accumulus Synergy , United States

Operationalizing Regulatory Content: A Future of Regulated Transactions

Jan  Benedictus, MS, MSC

Jan Benedictus, MS, MSC

Managing Director, Fonto, RWS, Netherlands

The Future of Documents: Structured Content and Integrated Data

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