Regulated Product Submissions (RPS) Vancouver Meeting Agenda September 2008

This page details the meeting agendas for Regulated Product Submissions Release 2 (RPS R2) scheduled Vancouver, British Columbia, the week of September 15, 2008.

Monday, September 15

Session 1: Q3 (1:45-3, room TBD)

Review of Iterations 1 and 2 NOTE: Business Scenarios reviewed in any given session is subject to change based upon this review and progress in any given session

Identify Mission Scenarios

Scenario and Storyboard Development Assignments

Requests and Responses Business Scenarios:

• Submission Activities
• Meeting Requests and Responses
• Pre-submission Activities

Action Items and Assignments

Session 2: Q4 (3:30pm-5pm, room TBD)

Business Scenarios:

• Remaining business on Requests and Responses scenarios from Q3
• Requests and Responses: Follow-up/Post-market
• Basic Contact and Product Information about the Submission [Information about the Submission (2.3)]

Action Items and Assignments

Tuesday, September 16

Session 3: Q1 (9-10:30am, Burrard Room in the south tower)

Referencing Business Scenarios:

• Referencing Information Owned by an External Party (2.2.5)
• Comparison Information (2.2.15)
• Reference Paper Information from Electronic Source (2.2.19)

Action Items and Assignments

Session 4: Q2 (11am-12:30pm, Parksville, north tower, level three)

Referencing Business Scenarios:

• Referencing Information Owned by an External Party (2.2.5)
• Comparison Information (2.2.15)
• Reference Paper Information from Electronic Source (2.2.19)

Action Items and Assignments

Session 5: Q3 (1:45pm-3pm, Parksville, north tower, level three)

Business Scenarios:

Action Items and Assignments

Session 6: Q4 (3:30pm-5pm, Parksville, north tower, level three)

Overview of the Domain Analysis Activities

Action Item Review

Wrap-up

Other Working Sessions

TBD