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Session 4: eCTD 4.0 in Action: Readiness and Alignment Across Global Health Authorities
Session Chair(s)
Tamei Elliott, MS
Director, Global Scientific Content, DIA, United States
Lorelle Leonienco, PMP
Executive Lead – Government & Regulatory Intelligence, LORENZ Life Science Group, United States
As health authorities worldwide move toward eCTD 4.0 implementation, global collaboration and harmonization are key to realizing its full potential. This session will bring together global regulators to share updates on regional progress, highlight opportunities to strengthen global alignment, and discuss how eCTD 4.0 can improve the quality, consistency, and efficiency of regulatory submissions. Participants will gain a high-level understanding of current timelines, readiness activities, and the broader vision for how eCTD 4.0 supports digital transformation and more agile regulatory review processes.
eCTD v4.0 Implementation Update
Jonathan Resnick, FDA
Kristiina Puusaari, European Medicines Agency, Netherlands
eCTD 4.0 in Action
Andrea Johnson, Medicines and Healthcare Products Regulatory Agency (MHRA)
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the overarching goals and expected benefits of eCTD 4.0 implementation across regions
Speaker(s)
eCTD v4.0 Implementation Update
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Speaker
Kristiina Puusaari, MBA, PMP
Digital Business Transformation Programme eSubmission Senior Coordinator, European Medicines Agency, Netherlands
eCTD 4.0 in Action
Andrea Johnson
Deputy Director of Future System Business Requirements, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
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