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Development of an Integrated Orphan Drug Framework in Canada

Global Regulatory

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:

Room Number:



Development of an Integrated Orphan Drug Framework in Canada

Barbara J Sabourin, FACP
Director General, Health Products and Food Branch
Health Canada, Canada

Health Canada is developing regulations, guidance and operational supports simultaneously for an integrated orphan drug framework that represents a significant departure from current practice. The session will offer insights into the management of a range of complex issues in developing an adaptive licensing framework for the full life cycle of a class of products, from predesignation to postmarket. Attendees will also learn how a full framework can be designed to reflect the national legislative context, and also to promote international alignment in implementation, to get drugs for rare diseases from brainwave (concept) to bench to bedside.

Learning Objective(s):
Discuss the key challenges of developing and implementing a completely new regulatory framework, and how can they be overcome; Describe how regulatory authorities promote excellence in clinical trials in small populations; Identify tools required to gather patient input and integrate it into regulatory decision making.

Presentation(s) & Speaker(s):
From Regulation to Implementation: Operationalizing a New Framework for Orphan Drugs
Cathy A. Parker
Senior Executive Director, Biologics & Genetic Therapies Directorate HPFB
Health Canada, Canada