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

Ottawa, Ontario
April 26, 2019

The purpose of this Notice is to announce an upcoming meeting of Health Canada's Scientific Advisory Committee on Health Products for Women (SAC-HPW).

The advice received from this meeting will be used to help inform the regulatory and scientific review of medical devices that are used in women.

Mandate of the SAC-HPW

To provide Health Canada with timely patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs. The Committee will examine issues across the product life cycle, from development to real-world use, with a focus on patient perspectives and experiences. This includes providing advice to help inform the regulatory review process, addressing specific questions on women’s health related to the evidence used to support the safety, efficacy and quality of drugs and medical devices, addressing questions on current and emerging issues (pre- and post-market) and identifying areas where clarification is needed with regard to policy, guidance and applicable regulatory requirements.

For more details on the mandate of the SAC-HPW, please refer to the Draft Terms of Reference of the SAC-HPW.

Meeting Format

Health Canada will present on each topic and pose questions to the committee.

Upon completion of the presentation and following discussion, the Committee will deliberate before providing recommendations to Health Canada.

Agenda

The following topics will be discussed:

• Clinical Evidence for Medical Devices;
• Lifecycle Management of Medical Devices; and,
• Knowledge Translation to Patients.

A more detailed agenda will be posted with this announcement.