Show:
Registration/GRIP Changes
Workflows/Misc
100
What Lifecycle state does MRI/RDA manually move the registration to (usually at Submission) and can be done from either the RO or Activity?

In-Progress

100
What days of the week does the eCTD submitted sequences report run to complete registrations?

Monday, Wednesday and Friday

200
Name two Lifecycle states for Activities that update based on pre-defined rules?

In Regional Assessment

Pending Strategy

200

True/False:

You will receive a workflow completion notification only if the LRR/RRL approves the registration workflow?

False

300

True/False:

You have to approve RO and complete all registrations in order to close out the approval GRIP request?

True

300

Give two submission examples when you would send a registration workflow for review?

Original MA

Original CTA

MA Renewal

Labeling Change with New Indiciation

400
How would the LRR/RRL send changes to us that they require on the registration they have reviewed?

AMGEN RIM and EPIC (until system retirement)

400

What action does MRI/RDA take if they receive a request to create a CMC L2 or L3 change events and activities?

Inform the requester that MRI are not responsible for this, add a comment to the Execution Notes, and cancel the request.

500

What action does MRI/RDA take if at the time of Proof of Submission request and the Event/Activity does not exist?

Query the requestor to have the GRL place a Submission Planning GRIP request to ask for the Events and Acitivities for that change. Place the Proof of Submission on hold until you hear further. 

500

What two GDEs are the most important as you get through R2

GDE 407487 - Submission Planning and Updates

GDE 407488 - Archiving