Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
Place: Holland Cross, Tower B, Room 2048
Date and Time: February 26, 2009, 8:00 to 16:00
Chairperson: Dr. Alexander Paterson
Science Advisor: Thea Mueller
Science and Regulatory Officer: Jackie Moore
Participants: SAC OT members and Health Canada
07:30-08:00
Refreshments
1.
08:00-08:10
Opening remarks
Barbara Benning, Senior Executive Director, Therapeutic Products Directorate (TPD)
2.
08:10-08:30
Conflict of Interest (COI) / Review of Agenda / Introduction to changes in meeting format
Chair
3.
08:30-09:00
Health Canada Presentation: Progression-Free Survival – A Follow-up
Martha Harczy / Questions from SAC
4.
09:00-09:45
Deliberations and Answer Part 1: Question 1
SAC-OT
09:45-10:00
Break
5.
10:00-10:45
Deliberations and Answer Part 1: Question 2
SAC-OT
6.
10:45-11:30
Deliberations and Answer Part 1: Question 3
SAC-OT
7.
11:30-12:00
Question and Answer Teleconference with Dr. Jennifer Knox
SAC-OT
12:00 -12:45
Lunch
8.
12:45-13:30
Deliberations and Answer Part 1: Question 4
SAC-OT
9.
13:30-14:00
Deliberations and Answer Part 1: Question 5
SAC-OT
10.
14:00-14:30
Health Canada Presentation: Progression-Free Survival as an Endpoint in Metastatic Renal Cell Carcinoma
Karen Johns / Questions from SAC
11.
14:30-15:15
Deliberations and Answer Part 2: Question 1
SAC-OT
15:15-15:30
Break
12.
15:30-16:00
Deliberations and Answer Part 2: Question 2
SAC-OT
13.
16:00-16:05
Next steps, Closing Remarks and Adjournment of Meeting