Workshop on Post Market Drug Safety and Effectiveness

University of Ottawa
Desmarais Building 55 Laurier East, Room 1150
May 22-23, 2008

A workshop sponsored by the Canadian Institutes of Health Research and the University of Ottawa.

Objective:

To discuss how to make optimal use of post-market evidence of drug safety and effectiveness to support decision making in the regulation of drugs and the management of public drug plans in Canada.

Background:

This is the second of series of ad-hoc workshops to discuss issues relevant to a proposal for the establishment of a pan-Canadian network of pharmaceutical research centres of excellence to close existing gaps in evidence concerning the safety and effectiveness of drugs when used post-market authorization, beyond the controlled setting of a clinical trial. Medicines that Work for Canadians: Business Plan for a Drug Effectiveness and Safety Network was released in 2007. It proposes a model for a virtual network in conjunction with a national oversight body comprised of key stakeholders which will establish priorities for research. The Business Plan is available on Health Canada's website.

The first workshop, Knowledge Translation in the Post Market Evaluation of Drug Safety and Effectiveness Data, was hosted by the McLaughlin Centre for Population Health Risk Assessment and held at the University of Ottawa on November 25 & 26, 2007. The purpose of the workshop was to discuss how to develop a coordinated Knowledge Translation (KT) process to improve drug safety and effectiveness in the real-world. A copy of the workshop report is available on the McLaughlin Centre website.

This second workshop will focus on how Canada could make optimal use of real world safety and effectiveness data and research results in a drug regulatory and reimbursement context. The discussion will be informed by Canadian case studies and international perspectives, exploring how other countries are generating and using post-market information.