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Difference between revisions of "Regulated Product Submissions (RPS) Vancouver Meeting Agenda September 2008"

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

Latest revision as of 04:32, 16 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