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

Date and Time: Friday November 2, 2018 / 9 am to 4 pm
Chairperson: Irvin Mayers
Science Advisor: Conrad Pereira
Scientific Regulatory Affairs Supervisor: Carl Poulin
Participants: SAC-RAT Members, Health Canada employees

9:00am-9:05am
Opening remarks
Director General, J. Patrick Stewart, Therapeutic Products Directorate

9:05am-9:20am
Introductions, Affiliations and Interests declarations, Review of Agenda, Introduction of new member Chair and members

9:20am-11:00am
Presentations:
- Comparative Pulmonary PK and in vivo bioequivalence of OIPs
- Quality considerations in the assessment of generic DPIs and pMDIs
Bureau of Pharmaceutical Sciences

11:00am-12:00pm
Discussion
SAC-RAT members

12:00pm-1:00pm
Lunch

1:00pm-3:45pm
Discussion and Recommendation
SAC-RAT members

3:45pm- 4:00pm
Next steps, Closing Remarks and Adjournment of Meeting
Chair