CCDS Label Change Management demo
Grows each Company Core Data Sheet change into a cascade: every country label it touches, the local text drafted, the submission type, and a forecast against each market's own deadline. 1:15
What the demo shows
A labeling solution for regulatory affairs that updates local labels after a CCDS change.
Six agents compare the old and new CCDS, classify each change, find every local label and section it lands in, draft the local wording from approved translations and registered deviations, and open a task per market. The Deadline Planner forecasts each market's filing date against its own deadline, marks the ones that will miss, and proposes a way back. The global labeling lead decides deviations and pull-forwards; affiliates approve the local text.
Transcript
- CCDS Label Change Management updates every local label as CCDS change touches for global labeling teams.
- One safety change lands in 16 markets, each with its own procedure and deadline.
- Today, Talmarek's 23.0 adds a warning for severe skin reactions.
- Maya runs the cascade.
- Six agents map every label, draft the text, and set each market's clock.
- Japan turns red. Its PMDA window closes October 28th, but it would file November 2nd.
- The deadline planner finds a way back.
- Express translation. Reviews section by section.
- Japan now files a day early.
- In Brazil, the Anvisa wording is kept in one click.
- Every label found on day one.
- And every market on its own clock.
- built on Botminds, agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.