2022 年 5 月 16 日

The Practicalities of Implementing eCTD 4.0

Part 1: People and Processes

The timelines for the implementation of eCTD 4.0 in the major markets are approaching. Although initially the use of the new standard will be optional it is becoming increasingly important to start preparations for what will be a significant change for Regulatory Affairs and in particular, those who publish, plan, author and review the submissions.

This series will examine some of the major considerations that will need to be addressed during an eCTD 4.0 implementation, beginning with the impact to people and business processes.

People Impacts

A successful implementation is not just reliant on the technology; one of the most important considerations is to understand and communicate the impacts on the end users. In any major change management program, buy-in from the people who will be directly affected is vital. Making the time to address the most basic questions should not be overlooked; given the opportunity to discuss these questions often highlights changes in business process that may not have been fully realized.

Identifying each role and providing regular oversight of the ‘What, Why, When and How’ will help to establish positive end user engagement. Encouraging ownership of the changes by identifying lead users to support the messaging and to coordinate questions, concerns, and feedback will start to build trust and confidence.

CALYX-20-Headshots-KarenHarry2-FINAL

“In any major change management program, buy-in from the people who will be directly affected is vital.”

– Karen Harry, Director Regulatory Information Management, Calyx

Business Processes

The management of processes across submission planning, authoring, publishing, and archiving requires a significant number of documents, varying from high level policies & SOPs to detailed step by step work instructions to be maintained.

eCTD 4.0 will require updates to existing processes and in preparation identifying documents that need to be updated by conducting a review of in-scope SOPs, Work Instructions and Quick Reference Guides will provide a starting point to help recognize potential gaps and the amount of work that will be needed to be eCTD 4.0-ready.

Because there will be a need to support both eCTD 3.2.2 and eCTD 4.0, both sets of documents will need to be available. Specifically for eCTD 4.0, thought should be given to new business processes with respect to the management and maintenance of structured data, impacts to the authoring processes, and additional requirements for reviewers.

Having made these assessments, a plan can be developed; identifying authors, reviewers, and the timelines for the updates. Coordinating the upload of the new processes in Learning Management Systems and identifying the impacted roles will also need to be considered to ensure that all end users have completed the training within the required timeframe.

The need to complete additional training and to update documentation will require time away from daily activities which may result in additional time pressures for end users, so it is important to factor these into the overall implementation plan.

User Awareness

Identify the audiences, the relevant content, and the cadence for awareness sessions in advance, make sure that attendance at the sessions is prioritized. Engage the lead user network to encourage attendance and to raise questions and topics to discuss in advance.

Among many other areas, understanding the practicalities of the hand-off content and the associated controlled vocabularies will need to be addressed along with any update to the reviewing process and impacts on submission planning timelines.

For companies that outsource publishing activities, communication will be crucial to ensure that the third-party companies are working with their teams to raise awareness of the forth coming changes and for the vendors to have a full understanding of the strategic plan for the company’s implementation of eCTD 4.0.

Don’t miss Part 2 of the series which focuses on socialising the new concepts, terminologies and the increased dependence on structured data.


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