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Session 9: Track 4: eSubmissions Revolution 2.0: Leveraging Lessons of Today’s Standards Implementations to Prepare for Increased Use
Session Chair(s)
Stacy Tegan
Program Director, Transcelerate Biopharma Inc., United States
It’s been almost 20 years since submissions were revolutionized to become “electronic.” Since that time, the way we access and consume information in every aspect of our lives has changed dramatically. It’s time for another revolution for submissions – one that will leverage structured contact and data standards. What changes are coming? What lessons of experience can we apply in the future? Session includes a case study of SEND standard implementation.
Learning Objective : At the conclusion of this session, participants should be able to:Explain how structured information improves regulatory review and describe potential areas for expanded use of standards and structured content
Speaker(s)
Katherine Dubrow
Research Scientist, Bristol Myers Squibb, United States
Standards Implementation: BMS Case Study and Plans for Expanding Use of SEND
Jared Lantzy, PMP
Executive Director, Global Regulatory Operations, Novavax, Inc., United States
eSubmission Evolution: Structured Data and Data Standards
Fred Wood, PHD, MS
Vice President, Consulting Services, Data Standards Consulting Group, A Division of TalentMine, United States
SEND: What is it and Where Are We as an Industry?
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