Dashboard: Expired and Expiring Registrations

This video details the functionality and operational requirements of a regulatory compliance dashboard, specifically focusing on managing product registrations that are either expired or approaching their expiration date. The dashboard, likely a component within a Veeva Vault Regulatory Information Management (RIM) system, is designed to provide immediate visual feedback and drive necessary regulatory actions to maintain compliance and market access. The presentation breaks down three primary components: the count of already expired registrations, a four-month expiry forecast, and a six-month expiry forecast.

The first and most critical component tracks registrations that have already passed their expiration date. This metric is color-coded, appearing red when the count is high, signaling an urgent compliance risk. To resolve an expired registration, the regulatory team must take one of two primary actions: either generate a new regulatory action to initiate the submission for renewal, or update the existing expiration date if the submission is already approved or pending final system update. The speaker notes that if a renewal is not planned, the product registration status must be formally updated within the system—options include changing the status to 'expired,' 'canceled,' 'discontinued,' or 'historic'—to remove it from the active, high-risk bucket. The integrity of the dashboard relies entirely on the accuracy of the expiration date field within the registration record.

The subsequent components, the four-month and six-month expiry forecasts, serve as essential proactive planning tools for the regulatory team. These forecasts identify registrations that will expire within the specified timeframe, allowing the organization to initiate submissions well in advance of the deadline. The speaker emphasizes that the timing of these forecasts is customizable; if a specific region requires a longer lead time for regulatory approval (e.g., six months), the forecast window can be adjusted accordingly. This flexibility ensures that the dashboard aligns with real-world regional regulatory timelines, optimizing the submission process.

A key operational insight provided is the necessity of early document preparation. For registrations appearing in the longer-term forecast (the six-month bucket), regulatory teams must immediately begin the process of requesting necessary supporting documents. The recommendation is to allow at least six months for the creation and gathering of these documents, highlighting the need for efficient internal workflow management and coordination between regulatory affairs and other departments involved in document generation. The overall methodology promotes a shift from reactive crisis management (addressing expired registrations) to proactive, planned submission management using integrated system dashboards.

Key Takeaways: • Expired Registration Resolution: Registrations that have already expired require immediate attention and can only be cleared from the high-risk dashboard component by either generating a new regulatory action for renewal, updating the expiration date (if renewal is pending), or formally changing the product status to 'expired,' 'discontinued,' or 'historic.' • Data Integrity is Foundational: The entire dashboard and its associated reports are driven by the accuracy of the 'expiration date' field on the registration record; maintaining up-to-date and accurate data in this field is crucial for effective compliance monitoring. • Proactive Forecasting: The 4-month and 6-month expiry forecast components are designed to enable proactive planning, allowing regulatory teams to initiate submission processes before the deadlines become critical, thereby minimizing the risk of market access disruption. • Customizable Lead Times: The forecast windows (4 months, 6 months) are not fixed and should be customized based on regional regulatory requirements and known approval timelines; if a region typically requires six months for approval, the forecast should be adjusted to match that lead time. • Regulatory Action Status Tracking: Registrations will remain in the 'expired' bucket even if a regulatory action has been created if that action is still in the 'planned' status; the system requires the action to be approved and the new expiration date updated before the registration moves out of the urgent queue. • Document Request Lead Time: A minimum of six months should be allocated for requesting and gathering necessary supporting documents for renewal submissions, especially for registrations appearing in the 6-month forecast, necessitating the creation of regulatory actions specifically for document requests ahead of the submission itself. • Dashboard Prioritization: The use of color coding (red for high counts/expired, green for low counts) provides a visual cue for regulatory teams to prioritize which registrations require immediate attention and resource allocation. • Status Management: Utilizing the full range of product statuses (canceled, discontinued, historic) is a necessary administrative step to ensure the dashboard accurately reflects currently active and relevant registrations requiring renewal, preventing clutter from legacy or irrelevant records.

Tools/Resources Mentioned:

• Veeva Vault (Implied, specifically Regulatory Information Management/RIM functionality)

Key Concepts:

• Regulatory Action: A formal workflow or process initiated within the Veeva system (or similar RIM platform) to manage a submission, renewal, or change request related to a product registration.
• Expiry Forecast: A proactive dashboard component that calculates and displays the number of registrations scheduled to expire within a defined future window (e.g., 4 or 6 months), serving as a trigger for planning and submission initiation.