Sponsored Webcast: One Foundation, Four Deadlines: Sequencing Structured Submissions Across a Staggered Global Timeline

ePI, eCTD v4.0, and structured CMC are being run as separate programs on separate clocks. However, they are one requirement with structured and reusable and traceable content, arriving in one region at a time. This webinar gives regulatory teams a way to decide first, what structure and then shows how Docuvera builds that single content foundation only once.

Upon completion of this webinar, attendees will have learned:

The current, staggered structured-submission timeline across PMDA, EMA, and FDA, plus EU ePI.
Why ePI, eCTD v4.0, and structured CMC are one content requirement, not four.
The sequencing decision: what to structure first, given each region’s status.
How reuse and traceability make structured content defensible at inspection and portable across regions.

Learning Objectives

Identify the current status and key timelines for ePI and eCTD v4.0 across PMDA, EMA, and FDA.
Explain the shared structured-content requirements underlying ePI, eCTD v4.0, and emerging structured CMC initiatives.
Prioritize which content to structure first based on regional requirements, portfolio needs, and submission timelines.
Evaluate how governed, component-level content reuse and traceability can reduce duplication and support regulatory defensibility.

Who Should Attend?

This webcast is designed for:

Regulatory affairs and regulatory operations professionals
Submission management and eCTD specialists
Labeling and ePI professionals
CMC regulatory and content teams
Regulatory information management leaders
Structured-content, content governance, and technology professionals
Digital transformation and regulatory systems leaders responsible for global submission readiness

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.