Meeting Minutes 5 April 2011

Notes from RPS WG Teleconference 5 April 2011

1. NOTES ON PREVIOUS MEETING

There were no comments about the notes from the previous minutes (except for banter about item 7).

2. OVERVIEW OF PRESENTATIONS & VOLUNTEERS

In response to the discussion last week about the need for more integrated and more tutorial materials Jason asked for suggested presentations and volunteers to put them together. The target presentations include: (a) scenarios and/or test cases (b) model walk-through and other tutorial material (c) eCTD to RPS terminology map (d) reference XML examples

• Marc volunteered to identify the test cases from the R2 DSTU exercise and post them to the wiki.

• Joe volunteered to check with ICH to see if the eCTD glossary that they had prepared could be made available for us to us. Keith volunteered to do the first cut at mapping it to RPS terminology (as defined in the Glossary and Submission Message)

• Jason will reach out to EU representatives to see if we can get someone to contribte to a better description of the new EU requirements.

• Keith volunteered to update the slide deck he had circulated earlier about document life cycle, but said that he would not do that until the outstanding review items concerning life cycle in RPS had been decided.

3. DISCUSSION OF MODEL WALK-THROUGH (Continued)

There role of regulatory and product metadata was discussed. It was agreed that this information was to be used for workflow or document management, and was not intended to be a complete description of the contents of the submission or application.

In a discussion of submission life cycle, Marc noted that the FDA might deem a submission withdrawn, but would not directly change its type; that would be communicated to the submitter separately and they would be expected to change it.

In a discussion of the APPEND operation, it was reported that ICH wants to eliminate that do to the problems that have been encountered with it in eCTD. It was noted that the RPS document construct enables APPEND to be eliminated. No decision was reached.

The FDA affirmed that content, once submitted, could not be deleted by any RPS operation.

4. OUTSTANDING REVIEW ITEMS

Keith gave a brief overview of the RPS: Life Cycle And State Transitions Document to orient readers in preparation for a more detailed discussion next week.