Scientific Advisory Committee on Respiratory and Allergy Therapies

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Contact: Bureau of Policy, Science and International Programs Enquiries

Agenda

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

Date and Time: Friday November 13^th 2009 / 9:00 a.m. - 4:30 p.m.

Participants:
SAC members and Health Canada

Chairperson:
Dr. Irvin Mayers

Scientific Advisor:
Bob Li

Scientific and Regulatory Officer:
Jackie Moore

1. Opening Remarks
   Dr. Irvin Mayers, SAC-RAT Chair
2. Introductions and Conflict of Interest Declarations
   SAC, moderated by Chair
3. Review of Revised Terms of Reference (ToR)
   SAC
4. Progress Update on Guidance Documents for Industry:
   
   1. Data Requirements for Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma;
   2. Data Requirements for Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis.
   Allergy and Respiratory Drugs Division (ARDD) Representative
5. Introduction: Data Requirements for Subsequent Market Entry (SME) Long-Acting Beta-Agonists (LABA) in the treatment of Chronic Obstructive Pulmonary Disease (COPD)
   ARDD Representative
6. Coffee Break
7. Committee Recommendations: Response to Questions concerning Therapeutic Equivalence Study Requirements for SME LABA in the treatment COPD
   SAC, Moderated by Chair
8. Lunch
9. Committee Recommendations: Response to Questions concerning Pharmacokinetic Study Requirements for SME LABA in the treatment of COPD
   SAC, moderated by Chair
10. Coffee Break
11. Summary of Committee Recommendations
    Chair
12. Next Steps and Closing Remarks
    Chair
13. Adjournment of Meeting