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Session 3 Track B - Labeling and Advertising and Promotion: Implementation of Health Canada’s revised Guidance for Industry: Review of Drug Brand Names
Session Chair(s)
Marc Poitras, PHD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada, Canada
Margaret Zimmermann
Manager, Patient Safety Section, Marketed Health Products Directorate
Health Canada , Canada
On June 13, 2015, Health Canada’s Guidance for Industry: Review of Drug Brand Names became effective. This session will walk through the revised guidance document providing information on what constitutes a brand name, brand name changes requiring an assessment, and the information to be provided to Health Canada in demonstrating the acceptability of a proposed brand name. Industry/Health Canada Perspective on the implementation of the Guidelines will be also be presented.
Speaker(s)
Overview of the Revised Guidance
Margaret Zimmerman
Health Canada (MHPD), Canada
Manager, Policy & Partnership, Marketed Health Products Directorate
Perspective from a Labeling Reviewer
Ana Nesic, MPHARM
Health Canada, Canada
Senior Regulatory Policy & Risk Management Advisor
Implementation of the Revised Guidance
Tharany Ganesh, MSC
AstraZeneca Canada Inc., Canada
Head, Regulatory Affairs