Bethesda North Marriott Hotel and Conference Center

Feb 03, 2025 7:45 AM - Feb 05, 2025 12:45 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 4: eCTD 3.2.2 & 4.0: EMA Updates & Industry Insights on Global Regulatory Efforts

Session Chair(s)

Tamei  Elliott, MS

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)

Lael  McCune

Overview of Global Regulatory eCTD 4.0 Efforts

Lael McCune

EXTEDO, United States

Pre-Sales Manager

Shenqi (Handsome)  Ji

Update on eCTD v3.2.2 Submissions

Shenqi (Handsome) Ji

Pfizer, China

Regional Publishing Lead, Asia, Global Regulatory Operations

Kristiina  Puusaari, MBA, PMP

eCTD v4.0 EU Implementation

Kristiina Puusaari, MBA, PMP

European Medicines Agency, Netherlands

eSubmission Programme Management, Human Medicines Evaluation

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