Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET) - Agenda, November 15-16, 2007

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Contact: Policy Bureau Enquiries

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Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET)

Agenda

Place:
1600 Scott Street, Ottawa
Holland Cross, Tower B, Room 2048

Date & Time:
Thursday November 15^th 2007/ 8:00 a.m. - 4:20 p.m., EST
Friday November 16^th 2007 / 8:00 a.m. - 12:30 p.m., EST

Participants:
SAC members, Health Canada and sponsor representatives (agenda items 12-16 only)

Chairperson: Dr. Peter Walker

Scientific Advisor: Dr. Colette Strnad

Logistics Coordinator: Jackie Moore

Day One

1. Opening Remarks
Dr. S. Sharma, Director General, Therapeutic Products Directorate, Health Canada

2. Introductions & Conflict of Interest Declarations
SAC, moderated by Chair

3. Review & Acceptance of Terms of Reference (ToR)

4. Presentation: Regulatory Review Process
Health Canada

5. Coffee Break

6. Presentation: Definitions and Clinical Trial Requirements for Prevention of Type 2 Diabetes Mellitus (T2DM)
Health Canada

7. Review of Stakeholder Comments and Committee Recommendations to Health Canada: Definitions and Clinical Trial Requirements for Prevention of T2DM (Questions 1-5)
SAC, moderated by Chair

8. Lunch

9. Final Recommendations to Health Canada (Questions 1-5, continued)

10. Brief Comments Regarding Day Two
Chair

11. Adjournment of Day One

Day Two

12. Opening Remarks
Chair

13. Presentation: Introduction of safety issues associated with rosiglitazone (Avandia)
Health Canada

14. Presentation: Rosiglitazone (including questions from the SAC)
Sponsor

15. Presentation: Rosiglitazone (including questions from the SAC)
Health Canada

16. Questions for the Committee
Health Canada

17. Coffee Break (sponsor leaves)

18. Closed Committee Discussion: Rosiglitazone
SAC, moderated by Chair

19. Final Recommendations to Health Canada concerning rosiglitazone
SAC, moderated by Chair

20. Next Meeting Date

21. Lunch / Meeting Adjourned