Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT) - Agenda

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

Date and Time: March 14, 2012/8:30am-4:00pm

Chairperson: Irvin Mayers
Science Advisor: Bob Li
Science and Regulatory Officer: Erica Harnett
Participants: SAC-RAT Members, Health Canada representatives

SAC-RAT members: Don Cockcroft, Myrna Dolovich, Allan Donner, Alan Kaplan, Redwan Moqbel, Parameswaran Nair, William Racz, Don Sin, Robert Schellenberg, William Swan, Susan Waserman

Health Canada representatives: Kimby Barton, Jatinderpal Raj Deol, Dominique Heon, Gail Grant, Barbara J. Sabourin, Ajaykumar Thaker, Violina Thomas, Jun Zhang

8:30 - 9:00 Refreshments

9:00 - 9:05 Opening Remarks (Barbara J. Sabourin, TPD)

9:05 - 9:15 Review of the Agenda, Declaration of Affiliations and Interests, Introduction of New Member, Announcement of ad hoc member change to core member status (Chair/SAC-RAT Members)

9:15 - 9:25 Review and Acceptance of Terms of Reference (Chair/SAC-RAT Members)

9:25 - 9:30 Introduction of issues (Ajaykumar Thaker, Bureau of Bureau of Cardiology, Allergy and Neurologica Sciences)

9:30 - 10:30 Review of Kelly et al's paper: Eosinophilic bronchitis in asthma: A model for establishing dose-response and relative potency of inhaled corticosteroids
(J Allergy Clin Immunol, 2006)

1. Presentation (Bob Li, Yongmin Yu, Bureau of Policy, Science and International Programs)
2. Questions and Discussions (SAC-RAT members and Health Canada representatives)

10:30 - 10:45 Break

10:45 - 11:30 Sputum Eosinophils: Review of comments from 60-day consultation period and questions to the committee (Draft Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroids Products for Use in the Treatment of Asthma)

1. Introduction
2. Discussions (Chair/SAC-RAT Members)

11:30 - 12:30 Lunch

1:00 - 1:45 Other issues: Review of comments from 60-day consultation period and questions to the committee committee (Draft Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroids Products for Use in the Treatment of Asthma)

1. Introduction
2. Discussions (Chair/SAC-RAT Members)

1:45 - 2:45 Committee Recommendations: Response to Questions concerning safety and efficacy requirements for SME ICS in the treatment of Asthma (Chair/SAC-RAT members)

2:45 - 2:55 Break

2:55 - 3:55 Committee Recommendations (cont'd): Response to Questions concerning safety and efficacy requirements for SME ICS in the treatment of Asthma (Chair/SAC-RAT members)

3:55 - 4:00 Next steps, Closing Remarks and Adjournment of Meeting