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RPS R2 MM 090106

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Regulated Product Submissions | Meeting Calendar | RPS Requirements Subgroup Meetings | RPS Meeting Minutes - January 6, 2009

Meeting Minutes

Meeting Details

Date: January 6, 2009

Time: 7:30 AM EST – 9:00 AM EST

HL7 Telecon: 770-657-9270 Participant Passcode: 745896




Preparation for WGM sessions

  • Multi-product Submission
  • Multi- Regulator submissions

Discussion of WGM sessions (Common Product Model, etc)

  • Questions


090106 Participants.gif

Action Items

  • Send updated document to the List Serve from the Multi-Regulator discussion
  • Send pre-read materials to the List Serve for the Requirements Subgroup sessions at the HL7 WGM in Orlando.
  • Schedule Common Product Model overview for the RPS R2 project team


HL7 WGM - Orlando - Schedule for the WGM for the Requirement subgroup: Tuesday, January 13, 2009 - Quarter 2 and Quarter 3

Follow up on Common Product Model presentation Peggy Leizear, Marti Velezis and Karin Sailor have been working to get a presentation on the Common Product Model. There may be time Thursday Q2 during the Common Product Model session to ask questions.

Planning for WGM in Orlando

The topics that will be discussed include Multi-produt and Multi-Regulator submissions. The discussion included what information would be required prior to the WGM in order to meet the objectives at the meeting. The main objective being to create the storyboards and update the domain analysis model with the resulting requirements of the two topic areas.

Multi-product submissions

There are several scenarios that have been discussed that need to be further analyzed. The current document for multi-product submissions is attached Media:RPS R2 Iteration 1 Product Information-KM.doc

In the next week we would like to identify the scenarios (in all affected regulated product areas) for multi-product submissions so that we can analyze the potential new requirements from those that may be handled by the existing set of requirements proposed in previous iterations and releases.

Multi-regulator submissions

The group reviewed an updated the business scenarios for the Decentralised procedure (DCP) for authorising human medicinal products in Europe. The group added comments in the note section for areas where futher work needs to be accomplish before the WGM. See attached document for the details of that discussion.Media:Multi Regulator Submissions Decentralised Procedure 090106.doc

In the next week, project team members should review the multi-regulator document that was posted to the listserve to identify if there are any additional scenarios and analysis (by mutual recognition or other national procedures and any other regional processes that should be included in iteration 2) that need to be added prior to the WGM in Orlando.

If you are interested in contributing to the definition and analysis of scenarios in the next few days, contact Marti[1].

Any final contributions to these two activities, should be posted to the listserve by Friday, January 9, 2009 COB for review and preparation for the RPS R2 Requirements subgroup meetings.