Regulated Product Submissions (RPS) Vancouver Meeting Agenda September 2008
Regulated Product Submissions | Meeting Calendar | F2F Meetings
This page details the meeting agendas for Regulated Product Submissions Release 2 (RPS R2) scheduled Vancouver, British Columbia, the week of September 15, 2008.
PLEASE NOTE: ALL TIMES ARE PACIFIC DAYLIGHT TIME (PDT)
Scenario References refer to the Storyboard development page (Regulated Product Submission Release 2 (RPS R2) Business Scenario Development)
Monday, September 15
Session 1: Q3 (1:45pm-3pm PDT, Junior Ballroom A)
Review of Iterations 1 and 2 NOTE: Business Scenarios reviewed in any given session are 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 (Scenario 2.1.1)
- Meeting Requests and Responses (Scenario 2.1.2)
- Pre-submission Activities (Scenario 2.1.4)
- Notification of Decision (Scenario 2.1.7)
Action Items and Assignments
Session 2: Q4 (3:30pm-5pm PDT, Junior Ballroom A)
Business Scenarios:
- Requests and Responses: Follow-up/Post-market (Scenario 2.1.3)
- Questions from Sponsor to Agency and Resulting Response (2.1.14)
- Questions from Regulatory Authority and Sponsor Response (2.1.15)
- Basic Contact and Product Information about the Submission as related to Request/Response Scenarios [Information about the Submission (2.3)]
Action Items and Assignments
Tuesday, September 16
Session 3: Q1 (9-10:30am PDT, Burrard Room in the south tower)
Referencing Business Scenarios:
- Provide Access/Permission to a Submission (2.2.13)
- Permit Use of Master File/Master Access File/Third Party Documentation (2.2.14)
- Comparison Information (Scenario 2.2.15)
Action Items and Assignments
Session 4: Q2 (11am-12:30pm PDT, Parksville, north tower, level three)
Referencing Business Scenarios:
- Referencing Information Owned by an External Party (Scenario 2.2.5)
- Reference Paper Information from Electronic Source (Scenario 2.2.19)
- Basic Contact and Product Information about the Submission as related to Referencing Scenarios [Information about the Submission (2.3)]
Action Items and Assignments
Session 5: Q3 (1:45pm-3pm PDT, Parksville, north tower, level three)
Business Scenarios:
- Labeling and Negotiations: Request for Additional Information (2.1.11)
- Interim Decisions (2.1.7 variant)
Open issues on Business Scenarios
- Parking Lot Issues
- Basic Contact and Product Information about the Submission [Information about the Submission (2.3) continued]
Action Items and Assignments
Session 6: Q4 (3:30pm-5pm PDT, Parksville, north tower, level three)
Overview of the Domain Analysis Activities
Action Item Review
Wrap-up
Other Working Sessions
Consolidation of Assignment Products
TBD
