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

Date and Time: Thursday October 29, 2020, 12:30pm to 3:30 pm EST; Friday October 30, 2020, 12:30pm to 4:30 pm EST
Location: Virtual
Chairpersons: Lorraine Greaves (Chair), Louise Pilote (Vice-chair)
Secretariat: Jenna Griffiths, Despina Miteva, Olufunmilola (Funmi) Adedeji
Participants: SAC-HPW members, invited ad-hoc members, and Health Canada employees

Day 1 - October 29, 2020:

12:30-12:45

Welcome and Opening remarks
Chief Medical Advisor, Health Canada and Senior Medical Advisor for Health Products and Food Branch (HPFB)

12:45-1:00

Chair's Address, Introduction of Members, Review of Affiliations and Interests (A&I), Review of Agenda
SAC-HPW Chair

1:00-1:15

Health Canada Presentation - Actions in Response to SAC-HPW Comments
Director General, Medical Devices Directorate (MDD)

Session #1: Sex and Gender-Based Analysis (SGBA+) Initiatives for Prescription Drugs and Medical Devices

1:15-2:00

Overview of Health Canada's SGBA+ Activities for Prescription Drugs and Medical Devices
Presenter: Manager, Office of Paediatrics and Patient Involvement, Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Invited researcher 1: Lorraine Greaves, Applying an SGBA+ lens to prescription drug lifecycle management
Invited researcher 2: Anna R. Gagliardi, Applying an SGBA+ lens to medical device lifecycle management

2:00-2:45

Session #1: Committee Deliberations
SAC-HPW members

2:45-3:00

Closing Remarks
Chair

3:00-3:30

In-camera Session
SAC-HPW core members only

Day 2 - October 30, 2020:

12:30-12:40

Chair's Address, Review of Agenda, Recap of Day 1
Chair

12:40-12:45

Session #2: Patient Experiences/Perspectives on Mesh Implant Products
12:45-1:10 Patient representative 1: Cynthia Gagné
1:10-1:25 Patient representative 2: Noreen Wideman

1:25-2:10

Session #2: Committee Deliberations
SAC-HPW members

2:10-2:25

Session #3: Post-market Activities on Mesh Implants
Presenter: Director (MDD)

2:25-2:55

Session #3: Committee Deliberations
SAC-HPW members

Session #4: Demonstration of the Public Release of Clinical Information (PRCI) Portal and the Regulatory Decision Summary (RDS) Database

2:55-3:10

Public Release of Clinical Information (PRCI) Portal
Presenters: Head of Operations and Senior Policy Analyst, Resource Management and Operations Directorate (RMOD)

3:10-3:25

Regulatory Decision Summary (RDS) Database
Presenter: Project Manager, Office of Planning, Performance and Review Services (OPPRS)

3:25-3:55

Session #4: Committee Deliberations
SAC-HPW members

3:55-4:10

Summary of Recommendations from Day 1 and Day 2 and Adjournment of Meeting
Chair

4:10-4:30

In-camera session
SAC-HPW core members only