Global Project Planning
Calyx RIM Global Project Planning (GPP) facilitates planning and data entry for multiple countries or multiple applications. The Project View provides a centralized view of all applications, events, event countries, notifications, and references associated with a project.
GPP facilitates the process of planning and executing regulatory submissions where there are multiple countries or regions, or multiple applications within the same country, that are targeted at the same time for the same change. GPP is a valuable tool when variations, supplements, annual reporting, and other submissions need to occur simultaneously in more than one country or region, or for more than one application.
The
GPP wizard enables you to create projects for:
- Creating applications for package set registrations
- Creating clinical trial authorization (CTA) applications
- Creating events for package set or product registrations
- Updating PDS details
- Withdrawing product package set registrations
Using the GPP, you can perform the following functions:
- Apply event plans to events
- Create sequences for applications
- Add, replace, or withdraw manufacturers in the PDS
- Add, modify, and withdraw package set component packaging
- Add species details to PDSs for veterinary product families
- Update the status and status date of event countries associated with a project
- Calculate projected dates for one or more event countries associated with a project
- Add event countries to project events
- Create sequences related to selected project events
- Create references for project events and sequences
- Associate workflows to events and sequences