Announcement of Meeting - Expert Advisory Committee on the Vigilance of Health Products - October 24-25, 2012

Ottawa, Ontario

October 17, 2012

This notice announces a forthcoming meeting of the Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP) on October 24-25, 2012, in Ottawa.

The purpose of this EAC-VHP meeting is to obtain recommendations, in consultation with stakeholders, on the openness and transparency of the Health Products and Food Branch's health product vigilance program.

In addition to the in-camera portion of the meeting, a three-hour portion of the meeting on October 24th will be open to stakeholders. Stakeholders were invited to observe and/or present as part of a questionnaire sent out by Health Canada in August and September 2012.

The questionnaire was composed of the following two questions:

1. What are your experiences regarding the openness and transparency of Health Canada's therapeutic health product vigilance program for marketed health products?
2. Have you ever looked for information on marketed health products on the Health Canada website and not been able to find it? If so, what type of information were you unable to find?

Although it is too late to accept further requests from the public to observe and/or present at the meeting, the EAC-VHP Secretariat can provide copies of the "Analysis of Stakeholders' Responses to Questions on Openness and Transparency - Summary Report". Requests can be sent to the Secretariat via its Contact Us page linked below.

Agenda

On October 24, the Committee will discuss the Health Products and Food Branch's Openness and Transparency Agenda and be provided with an international comparison of transparency in health product vigilance.

Individuals presenting from different sectors will outline their perspectives of Openness and Transparency based on the questionnaire sent by Health Canada.

Presenters were selected by the Marketed Health Products Directorate based on the material submitted. Attention was paid to ensure representation from all groups of stakeholders, namely, health professionals, patients/consumers, industry and academia.

On October 25, the Committee will discuss issues such as making the Summary Basis of Decision process more transparent to Canadians, the transition to the electronic Canadian Adverse Reaction Newsletter, and the potential for adverse reaction reporting to Health Canada via the eHealth infrastructure.

Committee Meeting Summary Report

The Committee Meeting Summary Report for the October 2012 meeting will be published on this Web site at a later date. You are invited to read the past Committee Meeting Summary Reports.

Mandate of the EAC-VHP

The mandate of the EAC-VHP is to provide Health Canada with on-going broad strategic policy and program advice on the safety and therapeutic effectiveness of marketed health products for human use. Health Canada, through the Health Products and Food Branch (HPFB), is Canada's federal authority responsible for the regulation of health products and food. The establishment of this committee is part of a series of measures to modernize the regulatory system so that Departmental decision-making is more open, transparent and accountable to stakeholders and the public.

For more details, please refer to the Terms of Reference of the EAC-VHP.

Contact

For additional information, contact the Expert Advisory Committee on the Vigilance of Health Products.