One Foundation, Four Deadlines: Sequencing Structured Submissions Across a Staggered Global Timeline | RAPS

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 helps regulatory teams decide what to structure first and shows how Docuvera builds that single content foundation once.

Upon completion of this webinar, attendees will have learned:

1. The current, staggered structured-submission timeline across PMDA, EMA, and FDA, plus EU ePI.

2. Why ePI, eCTD v4.0, and structured CMC are one content requirement, not four.

3. The sequencing decision: what to structure first, given each region’s status.

4. How reuse and traceability make structured content defensible at inspection and portable across regions.