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Proprietary Name Review: International Perspectives from the FDA, Health Canada, and EMA

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
311

Room Number:
6D

Level:
Intermediate

Type:
Session

Title:
Proprietary Name Review: International Perspectives from the FDA, Health Canada, and EMA

Chair(s):
Lina Aljuburi, PharmD, MS
Director, Global Regulatory Policy
Merck & Co., Inc., United States

Description:
A trademark that minimizes the risk for medication errors is important to all stakeholders. Learning the role of trademarks and review is critical to the success of the process. An international panel of regulators will discuss the approach they take.

Learning Objective(s):
Discuss trademark development and review processes; Identify the important role of trademarks; Assess take-away points to improve internal company processes.

Presentation(s) & Speaker(s):
FDA Perspective
Kellie Taylor, PhD, MPH
Acting Director, Division of Medication Error Prevention and Analysis, CDER
FDA, United States

Health Canada's Revised Guidance For Industry: Review of Brand Names Past, Present, and Future
Cathy A. Parker
Senior Executive Director, Biologics & Genetic Therapies Directorate HPFB
Health Canada, Canada

EMA Perspective
Isabelle Moulon, MD
Head of Medical Information
European Medicines Agency, European Union, United Kingdom