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

Date and Time: Friday, February 23, 2018 / 9am to 4pm
Chairperson: Irvin Mayers
Science Advisor: Conrad Pereira
Scientific Regulatory Affairs Supervisors: Larissa Lefebvre and 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 - 10:20am
Presentation: Establishing Therapeutic Equivalence for Subsequent
Market Entry orally inhaled products submitted as an Abbreviated New Drug Submission (ANDS)
Bureau of Cardiology, Allergy and Neurological Sciences and
Bureau of Pharmaceutical Sciences

10:20am - 11:20am
Discussion
SAC-RAT members

11:30am - 12:30pm
Fingerprinting for members

12:30pm - 1:15pm
Lunch

1:15pm - 2:45pm
Discussion and Recommendation
SAC-RAT members

2:45pm - 3:00pm
Overview of Population Bioequivalence (PBE)
Biostatistics, Bureau of Policy, Science and International Programs

3:00pm - 3:30pm
Presentation and Recommendation
Data Requirements for Strengths of Orally Inhaled Drug Products not administered in In Vivo Studies
Bureau of Pharmaceutical Sciences

3:30pm - 3:45pm
Future direction of the committee and membership list
Chair and members

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