Project Development and Execution

Project: Drug Product Monograph
New Format – October 1, 2004:     [English]      [Français]

Client: Health Canada

Description: A product monograph is a regulatory document developed by the manufacturer and approved by Health Canada that is the end product of a drug review. There were two parts to this project: 1. to redesign the format and content of the monograph to make it more user friendly for health professionals and consumers; 2. to incorporate these changes into a comprehensive revision of the guidance document used by manufacturers to prepare monographs

Skills used: Pharmaceutical knowledge, clinical practice experience, research and analysis, publishing experience, working with focus groups, interviewing, industry validation, training

Outcome: Implementation of the new design and the revised pharmaceutical industry guidance document