Scientific Advisory Committee on Health Products for Women (SAC-HPW): Nomination Call for Members

Ottawa, Ontario

January 30, 2019
Our file number: 19-101176-709

As part of its “Action Plan on Medical Devices”, announced in December 2018, Health Canada is establishing a new external Scientific Advisory Committee on Health Products for Women (SAC-HPW).  The SAC-HPW will 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, and 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.

Health Canada is seeking nominations (including self-nominations) for up to 12 SAC-HPW core members as well as for ad hoc members. Core members will be permanent members for the duration of their two year terms and ad hoc members will be invited to serve for a specific topic or group of topics. Nominees may include: patient groups, health professionals such as pharmacists, physicians and nurse practitioners; scientists; experts from industry, academia, and/or public policy. Areas of expertise could include:

• women’s health research including research ethics
• first-hand personal experience as, for example, a health professional, patient, or caregiver
• clinical trial or investigational testing involving women
• sex and gender-based analysis (particularly for drug or device development)
• medical devices (including devices unique to women such as breast implants, contraceptive devices)
• drugs (pharmaceuticals, biologics, gene therapies) including regarding sex-based differences for safety and/or efficacy
• post-market real world issues with drugs and devices related to women’s health
• Indigenous women’s health issues, and/or
• other relevant expertise

Members will be selected by the Health Canada Management Committee (see link below for Terms of Reference) following a review of all nominations by a Health Canada selection committee. Decisions will be based on the required expertise, the individual's breadth of experience and his or her familiarity with committee work. We will strive to have membership that reflects a balance of gender and regional representation, covering various areas of expertise, knowledge, and perspectives.

Important Information for potential members:

• The first meeting will be held in spring 2019 in Ottawa.
• You must participate as a volunteer; however all travel and accommodation expenses will be compensated according to the relevant Treasury Board policies.
• Committee members must undergo government security clearance and provide a declaration of their Affiliations and Interests. A summary of this information will be posted to Health Canada's website.
• Additional information on how the Committee will be selected and its functioning can be found in the attached Terms of Reference and the Health Canada Policy on External Advisory Bodies (2011).

The nomination should contain the following information: name; contact information; area of expertise and rationale. It should be no longer than 500 words. Nominations should be sent by February 22, 2019 to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Or via email to: hc.policy.bureau.enquiries.sc@canada.ca

Thank you for your interest in this important initiative.