RPS 2 Vancouver Working Group Meeting

An RPS2 Working Group meeting was held in Vancouver the week of September 15.

The working group discussed a number of business scenarios including:

Two Way Communication – Pre-Submission Correspondence

Submission Activities – Request Submission Number

Submission Activities – Meeting Request and Responses

Notification of Decision or Action

Request/Response for Additional information during a review cycle

Follow-up/Postmarket Correspondence

Referencing – Permit Use of Master file, Master Access File or Third Party Documentation

Referencing – Comparison Information

Referencing – Reference Information sent to an external party

Referencing - Paper Submission

Labeling Negotiations

Interim Actions (i.e., complete response letter, tentative approval, non-final actions, hold decisions, etc.)

Administrative Actions – Technical/Validation Reports/Errors

Some of these scenarios were removed from requirements iteration #1 or merged with other scenarios.