Scientific Advisory Committee on Health Products for Women (SAC-HPW)

Date and Time: Thursday June 27, 2024, 3:00-5:15 pm EST
Place: Zoom
Chair: Lorraine Greaves (Chair), Louise Pilote (Vice-chair)
Secretariat: Centre for Policy, Pediatrics and International Collaboration (CPPIC)
Participants: SAC-HPW core members, Health Canada employees

3:00-3:10
Welcome and Opening Remarks
Sophie Sommerer, Director General, Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Products and Food Branch (HPFB)

3:10-3:20
Chair’s Address, Introduction of Members, Review of Affiliations and Interests (A&I), Review of Agenda
Dr. Lorraine Greaves, SAC-HPW Chair

3:20-3:35
Session #1: Update on Breast Implants and Government Response
Bruce Randall, Director General, Medical Devices Directorate (MDD)

3:35-3:50
Session #2: Committee Questions, Feedback and Recommendations
SAC-HPW members

3:50-4:00
Session #3: Clinical Trials Modernization
Brian Parker, Associate Director, Bureau of Policy, Science and International Programs (BPSIP), Pharmaceutical Drugs Directorate (PDD)

Objective: To provide an overview of the proposed clinical trials modernization initiative. This will set-up the discussion for the remainder of the meeting on the proposed sex and gender based analysis (SGBA) plus component of the clinical trials modernization initiative.

4:00-4:10
Session #4: Committee Questions, Feedback and Recommendations
SAC-HPW members

4:10-4:20
Session #5: Integrating SGBA Plus-Related Components in the Clinical Trials Modernization Initiative
Tanya Pires, Regulatory Policy and Risk Management Specialist, CPPIC, BRDD

Objective: Discuss and seek feedback from SAC-HPW with re to SGBA Plus CT Guidance.

4:20–4:50
Session #6: Committee Questions, Feedback and Recommendations
SAC-HPW members

4:50-5:00
Review of SAC-HPW Recommendations
Alysha Croker, Director, CPPIC

5:00-5:10
Secretariat Update
SAC-HPW Secretariat

Objective: Inform members of relevant operational updates and timelines (e.g., meeting Record of Proceedings (RoP); date/theme of upcoming meetings; future planning for committee, including revision of the Terms of Reference and membership).

5:10-5:15
Closing and Adjournment of Meeting
Chair

5:15
In-Camera Session
SAC-HPW members only