Canada Vigilance Expert Working Group

The Canada Vigilance Expert Working Group will assist Health Canada to implement electronic reporting by industry and clinical trial sponsors. The reporting will include post market and clinical trial adverse reaction information in accordance with international and Health Canada's standards.

Mandate

This working-level expert group is in line with the approach established by other regulatory agencies such as the European Medicines Agency (EMA).

The Canada Vigilance Expert Working Group will help implement electronic adverse reaction reporting by providing guidance, expertise and input to Health Canada on the following:

• approaches and timelines for dissemination of information to stakeholders
• planning and support of pilot activities required to implement electronic reporting by industry and clinical trial sponsors
• user requirements for stakeholders
• business rules and guidance for electronic reporting, trading partner agreements, and other activities
• establishment of ad hoc expert working groups to address specific project deliverables, their membership composition, the invitation and selection process

Membership

Health Canada appoints members of the working group through a call nomination system.

The working group includes governmental and non-governmental representatives.

Non-governmental representatives were drawn from a cross section of the Canadian industry and clinical trial sponsors who have a legal obligation to report adverse reactions to Health Canada. The group includes members representing the following sectors:

• pharmaceutical drugs
• biologics
• radiopharmaceuticals
• natural health products
• vaccines

The governmental representatives were drawn from the Health Products and Food Branch (HPFB) and the Corporate Services Branch (CSB) of Health Canada.

Additional Information

• Terms of Reference of the Canada Vigilance Expert Working Group
• For more information on the Canada Vigilance Expert Working Group, contact the Canada Vigilance Program.