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Session 6 Track 4: Submissions Are Data – Changing Formats and Improving the Submission Process
Session Chair(s)
Joel Finkle
Industry Expert
Retired, United States
Submission format changes are coming and are more like a database than a table of contents. The trend that started with US FDA’s Module 1 and the HL7 RPS project is finally coming to life in eCTD 4.0. Meanwhile, EMA’s DADI initiative, the HL7 FHIR format, the Eurasian Economic Union’s submission format, and others, should make it easier to maintain submissions and submission software.
Learning Objective : At the conclusion of this session, participants should be able to:
- Communicate trends in electronic regulatory submissions
- Prepare for new submission requirements in Europe, Japan and elsewhere
- Evaluate costs and benefits of upcoming agency format changes
Speaker(s)
You Got Your Data in my Submission Format! You Got Your Submission Format in my Data!
Joel Finkle
Retired, United States
Industry Expert
SPOR-DADI-ePI - The Future Starts Now and is on FHIR
Frank Dickert
EXTEDO Gmbh, Germany
Senior Business Consultant
Journey to eCTD 4.0 Standard: Simplifying the Review of Regulation
Sadia Ahmed
IQVIA, United States
Associate Director Product Management, Regulatory Technology