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Session 4: eCTD 3.2.2 & 4.0: EMA Updates & Industry Insights on Global Regulatory Efforts
Session Chair(s)
Tamei Elliott, MS
Director, Global Scientific Content
DIA, United States
This session will provide an in-depth overview of the latest developments in global electronic submissions, with a primary focus on regulatory agency perspectives on eCTD 3.2.2 and eCTD 4.0. Attendees will gain insights into ongoing global regulatory efforts and specific agency initiatives, such as the EMA’s technical pilot of eCTD 4.0. This discussion will bring together key perspectives from regulatory authorities and industry representatives to outline the evolving regulatory landscape and expectations for future electronic submissions.
Handsome Ji, Pfizer
Lael McCune, EXTEDO
Kristiina Puusaari, European Medicines Agency
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the current regulatory landscape for eCTD 3.2.2 and eCTD 4.0
- Gain insights on the EMA’s pilot program for eCTD 4.0
Speaker(s)
Overview of Global Regulatory eCTD 4.0 Efforts
Lael McCune
EXTEDO GmbH, United States
Pre-Sales Manager
Update on eCTD v3.2.2 Submissions
Shenqi (Handsome) Ji
Pfizer, China
Publishing Regional Director, Asia, Global Regulatory & International Operations
eCTD v4.0 EU Implementation
Kristiina Puusaari, MBA, PMP
European Medicines Agency, Netherlands
Digital Business Transformation Programme eSubmission Senior Coordinator