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Agenda: February 26, 2009, Scientific Advisory Committee on Oncology Therapies (SAC-OT)

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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