Teleconference: Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT) – October 26, 2012

Teleconference

Agenda

• Date and Time: Friday, October 26, 2012, 1:00pm - 3:30pm
• Chairperson: Irvin Mayers
• Science Advisor: Bob Li
• Science and Regulatory Officers: Erica Harnett, Caroline Hunt
• Participants: SAC-RAT Members, Scientific Advisory Committee for Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP) Members, Health Canada

1:00pm - 1:05pm

Opening remarks (Barbara Sabourin, Director General, Therapeutic Products Directorate)

1:05pm - 1:20pm

Introductions, Affiliations and Interests declarations, Review of Agenda, Introduction of new member (Chair and members)

1:20pm - 1:30pm

Introduction of the issue - Data requirements for determining bioequivalence of nebulizer suspensions (Craig Simon, Bureau of Pharmaceutical Sciences)

1:30pm - 1:35pm

Questions for Health Canada (members)

1:35pm - 3:25pm

Deliberation of questions (members)

3:25pm - 3:30pm

Next steps, Closing Remarks and Adjournment of Meeting (Chair)