Systems
This system first went live at Astellas on November 11, 2011.
What is Planisware?
This chart is most commonly used to provide project updates to management.
What is a Gantt?
This submission is made to the TPD for drug approval in Canada.
What is NDS?
Mirabegron
What is Myrbetriq?
A Project Team is typically required to visit this committee prior to a GDC.
What is SRM?
This system is a global system that contains all regulatory submissions and correspondence.
What is Veeva Vault?
This describes the longest sequence of activities in a project plan which must be completed on time for the project to complete on time.
What is Critical Path?
This submission is used for marketing approval for a biologic.
What is a BLA?
Solifenacin
What is Vesicare?
This document is submitted to GDC for xDAP.
What is a GDP?
This is the name of the original system used to store all governance documents.
This helps a project team break down working into smaller tasks.
What is Work Breakdown Structure (WBS)?
What is MAA?
Tacrolimus
What is Prograf?
This committee approves a project based mainly on the scientific merit.
What is GDC?
System that is used to send budget information to corporate finance.
What is Anaplan?
This describes a limitation or restriction to the timeline.
What is a constraint?
A new drug submission in Japan is submitted to this agency.
What is PMDA?
Enfortumab Vedotin
What is Padcev?
This committee is only required for SDAP, & FDAP.
What is EC?
Actual invoices are received through this system. It is also used for time reporting.
What is SAP?
This is used to ensure the first task is finished before the second task starts.
What is a Finish-to-Start Link
This describes the format used for global regulatory submissions.
What is eCTD?
Romosozumab
What is EVENITY?
This financial report from Helix is included in the GDP.
What is the GDC Budget Report?