eCTD 4.0 Migration: Managing the Technical Hurdles of the New Electronic Submission Standard for Global Filings
Date: June 10, 2026
Duration: 60 Minutes
Time: 12 PM EST
Why You Should Attend
The “old way” of managing submissions—relying on rigid folder structures and manual hyperlinking—is becoming obsolete. eCTD 4.0 introduces bi-directional communication, document reuse, and advanced lifecycle management that can significantly reduce submission timelines. However, the technical hurdles are steep.
Attending this session will move you beyond the theoretical ICH guidelines and into the reality of implementation. You will learn how to:
- Avoid the “Refuse to File” traps associated with new XML schemas and UUID (Universally Unique Identifier) requirements.
- Bridge the gap between current 3.2.2 systems and the 4.0 future without duplicating your workload.
- Understand the “Forward Compatibility” pilots currently being run by the EMA and FDA.
Key Topics to be Covered
- The New XML Backbone & Metadata Revolution: Moving from regional DTDs to a single, harmonized ICH XML schema based on HL7 RPS standards.
- Document Lifecycle Operations (The “Replace” Logic): Master the new “one-to-many” and “many-to-one” document replacement capabilities that replace the old “Append” and “Replace” functions.
- Controlled Vocabularies & Keyword Management: Transitioning from free-text headings to standardized, machine-readable keywords for better reviewer navigation.
- The Challenge of Active Dossier Migration: How to handle ongoing applications that were started in 3.2.2. When and how to “baseline” for a 4.0 transition.
- Bi-Directional Communication: Preparing your IT infrastructure to receive “Information Requests” and “Reviewer Comments” directly through the eCTD gateway.
- Global Roadmap & Mandatory Deadlines: A 2026–2030 compliance calendar for the US, EU, Japan, Canada, and Australia.
- Software Validation & 21 CFR Part 11: Technical requirements for upgrading your publishing tools and ensuring audit trail integrity in a data-driven environment.
Who Will Benefit
This webinar is specifically designed for high-level professionals who manage the technical and strategic aspects of regulatory filings:
- Regulatory Affairs Directors & Managers: To lead the strategic transition and manage regional compliance risks.
- Regulatory Operations & Submission Managers: The “power users” who need to understand the granular changes in XML building and validation rules.
- IT & System Architects: Professionals responsible for upgrading RIM (Regulatory Information Management) and eCTD publishing software.
- Quality Assurance & Compliance Officers: To ensure that new digital workflows meet data integrity and 21 CFR Part 11 standards.
- Clinical Data Managers: Who must understand how structured data from clinical trials will now integrate more tightly with the eCTD backbone.
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
