Project Leadership Team Meeting Minutes: 16-Mar-2010

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Present: Geoff Williams, Mark Gray, Mary Padgett, Joel Finkle, Andrew Marr, Joerg Lautz, Pam Cafiero, Taku Watanabe, Bob Gatling, Jason Rock, Luois Boulay, Bernie Liebler, Joe Cipollina

1. Minutes and Actions from Last Meeting The notes from the last meeting were published on Monday, not according to the timeline agreed at the last meeting (within 24hrs). This was partly due to Geoff learning to edit Wiki pages at the same time.

The action to follow up with Don Lloyd of HL7 was about to be completed. Post Meeting Note: A message explaining the way that the RPS Project has used the terms R2 and R3 was sent to Don. The message proposed that no review or effort to change the naming/numbering be undertaken until at least the end of 2010, when the alignment and plans for the two pieces of work will be better understood.

2. Regional/Domain Objectives The action to send regional/domain objectives for the R3 project to geof has been completed by Louis (for HealthCanada) and Taku (for PMDA). Geoff will write something up for EFPIA/EU. Mark promised something from FDA (CDER) by end of Thursday.

Geoff asked if it was explicitly stated anywhere, by any of the regulators, exactly which submission types they planned to use the RPS message for. For example, FDA CDER uses the current eCTD specification for INDs and NDAs (and DMFs and ANDAs). This is not explicitly stated in the RPS R3 project plan, though the implication is that by using the RPS message to align with the ICH goals and objectives, the currently accepted set of submission types will be accepted in RPS R3. The interesting thing is whether there might be submission type specific vocabularies developed, rather than a fit to the current ICH eCTD (e.g. an IND specific vocabulary so that the exact reqirements of the IND could be met). Mark said that there had been some "corridor conversations" to start a discussion on this within CDER, but nothing more in depth than this. Geoff suggested that the regional/domain objectives might like to be a little more explicit as to what types of submission might be included or excluded.

Geoff plans to update the Project Plan on Friday this week with the comments on objectives (and other areas) and sned this around for final review to the Listserv on Friday/Monday for discussion and completion at the meeting next Tuesday (23rd March).

While discussing this topic, mark asked if the project panned to use the regular Project Working Group Meeting slots for discussion on requirements. Geof said that this would be OK, as long as any other project communication and update messages were also given some time in the time available. Certainly, it would be sensible to avoid setting up a separate meeting if there was time available in the Working Group Meeting time.

3. Project Timelines There was a long discussion on the project timelines that have been proposed so far in the Project Plan document. As currently described (in Section 3 of v0.3) the timeline proposes a DSTU ballot in Jan 2011 and Normative Standard ballot in Jan 2012.

In working back from a DSTU ballot date of Jan 2011, we covered a number of the planned milestones. The Ballot package has been identified as needing to be prepared from Oct 24th 2010, thrugh to the end of November. Prior to this date would be a period to carry out the modelling and develop three deliverables, the RIM Model (the diagram with the coloured boxes and arrows!), the description of the state transitions (e.g. if a submission is "in review" what comes next?) and the update of the descriptive walkthrough of the standard. Jason commented that for many of the other projects he has worked on, the development of the model, the creation of these documents and their review has taken as long as the requirements gathering (if not longer). Jason also commented that the review, particularly of the RIM model, was important because if errors are found during the DSTU ballot, these can only be corrected by a second DSTU ballot.

Assuming we build more time into the plan for the preparation of the model and the associated documents, then this work would probably need to begin no later than June 2010. This date has two potential problems associated with it. It cuts down the time for the development of the regional/domain requirements (which are in varying states of readiness now) and also does not allow us to take learnings from the R2 DSTU testing. The current R2 DSTU testing pan does not foresee delivery of a tool to enable testing before the end of June or in early July, which would be too late to allow any testing conclusions to be incorporated into the R3 model development.

Because of the link to the work in the R2 DSTU testing, it was decided to move the DSTU ballot for R3 back to May 2011. A four month addition to the timeline should allow more opportunity to transfer learnings from the R2 DSTU testing into R3. There was a view expressed by several people that we would like to get this right first time, rtaher than have to run another project (R4!!!) to fix things in the future.

As a result of proposing to move the DSTU ballot to May 2011, it was also decided to move the Normative Standard ballot to May 2012. It was felt that compressing the DSTU reconciliation and testing into an 8 month period was not realistic.

Geoff will incorporate these changes into the update to the Project Plan.

4. AOB There was no other business

Next Meeting: Tuesday 30th March. The European clocks wil have changed by then so the 7.30am EDT time will be 12.30pm (BST) and 1.30pm (CET). Japan does not change its clocks for daylight savings, so the meeting will be at 8.30pm. Mark and Bernie will not be available to join the meeting.

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