RPS R2 MM 090825

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Regulated Product Submissions | RPS Requirements Subgroup Meetings

Meeting Agenda:

   * Discuss Scope for next lifecycle Media:RPS R2 Scope Discussions 29082009.pdf
   * Other?

Date: Tuesday, August 25, 2009

Time: 7:30 AM EDT - 9:00 AM EDT

Phone Number: 770-657-9270

Participant Passcode: 745896

Webinar: http://www.mymeetings.com/nc/join.php?i=SA300482&p=RPS2&t=c

Meeting Notes:

  • M.Velezis reviewed the presentation and each of the scope topics. WGM will be focused on discussing scope topics and providing a recommendation to the project team with prioritized scope topics. Meetings leading up to the WGM will be to refine the scope topics for discussion during WGM.

  • M.Velezis to connect with J.Cippolina to confirm the ICH requirements mappings to RPS R1 and R2 requirements and identify outstanding requirements that need to be discussed in detail during the WGM. If unable to validate mappings, the current mappings will be distributed to the group for discussion.

  • M.Velezis will distribute an agenda for the next set of meetings.

  • Next meeting is Tuesday, September 1, 2009 to discuss ICH Requirements.